Effectiveness of peer-group therapy using community based participatory research model on medication adherence among patients of diabetes and/or hypertension: Study protocol for a multi-centercluster randomized trial in rural settings across India (PARTICIPATE study)

Effectiveness of peer-group therapy using community based participatory research model on medication adherence among patients of diabetes and/or hypertension: Study protocol for a multi-centercluster randomized trial in rural settings across India (PARTICIPATE study) | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effectiveness of peer-group therapy using community based participatory research model on medication adherence among patients of diabetes and/or hypertension: Study protocol for a multi-centercluster randomized trial in rural settings across India (PARTICIPATE study) Pooja Reddy, Anuja Jha, Harshal Gupta, Vivek Verma, Dinesh Kumar, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5772282/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 06 Nov, 2025 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background : According to the WHO, more than 50% of patients do not take their medications as prescribed. Nonadherence is caused by several variables, such as social and economic factors, issues with the healthcare team and system, problems relating to specific diseases, characteristics of those diseases, and their treatments. Objective : To study the effectiveness of PARTICIPATE intervention at community level regarding medication adherence among diabetes and/or hypertension adults in rural India. Study design : This is a multicenter cluster randomized trial implemented across 04 blocks (64 villages) of 04 districts in East, West, North, and South India, and will cover 2880 randomly selected participants, with a nested economic evaluation to measure the effectiveness of community-based participatory research (CBPR). The intervention will be delivered by peer educators identified from the community for the duration of 12-month with the first 6 months, followed by once monthly for the next 6 months, and the control group continue to receive all aspects of standard care offered by healthcare providers (public or private). Methods : The measure of drug adherence for hypertension and/or diabetes, as determined by the self-reported Morisky Medication Adherence Scale (MMAS-8) at baseline, midterm, and end, is the study's outcome variable. The independent variables, viz., socio-economical and number of antihypertensive and/or antidiabetic drugs and their duration, self-perceived health status, systolic and diastolic blood pressure and/or HbA1c, will becontrolled while doing the analysis. Secondary outcomes include improvement in health literacy using All Aspects of Health Literacy Scale (AAHS), clinical outcomes, quality of life using EURO-QoL (EQ-5D), cost-effectiveness and return on investment (ROI). Process evaluations will be conducted with a sub-sample of participants to examine engagement in various intervention components. The fidelity of intervention will be monitored using the Normalisation Process Theory framework. Discussion : To the best of our knowledge, this is the first multi-centre cluster randomized controlled trial in India to assess the effectiveness of CBPR approach for improving medication adherence among diabetics and hypertensives. The results of this study will contribute to the evidence of scaling-up peer-educator models for diabetes and hypertension management in India and similar low-and middle-income countries. Trial registration : The registration number for this trial is CTRI/2024/01/061939 Medication adherence Peer group therapy Community-based participatory research (CBPR) Diabetes Hypertension India Figures Figure 1 Figure 2 Administrative information Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/). Title {1} Effectiveness of peer-group therapy using community based participatory research model on medication adherence among patients of diabetes and/or hypertension: Study protocol for a multi-center cluster randomized trial in rural settings across India (PARTICIPATE study) Trial registration {2a and 2b}. The registration number for this trial is CTRI/2024/01/061939 Protocol version {3} Version 6.0,28 February 2024 Funding {4} Financial support from Indian Council of Medical Research (ICMR) under National task force on Safe and Rational Use of Medicine. Author details {5a} Pooja Reddy, Professor and Head, Dept. of Pharmacology, Sri Aurobindo Medical College and PGI, Indore, MP, India-453555 Anuja Jha, Associate Professor, Dept. of Pharmacology, Sri Aurobindo Medical College and PGI, Indore, MP, India-453555 Harshal Gupta, Professor, Dept. of Community Medicine, Sri Aurobindo Medical College and PGI, Indore, MP, India-453555 Vivek Verma, Assistant Professor, Department of Statistics, Assam University, Silchar, Assam Dinesh Kumar, Professor, Department of Community Medicine, Dr. Rajendra Prasad Government Medical College, Kangra, Tanda, Himachal Pradesh, India Avi Kumar Bansal, Scientist E, National JALMA Institute for Leprosy and Other Mycobacterial Diseases, Tajganj, Agra, India Smita Mahapatra, Nodal Officer, MRU, Prof and HOD, Transfusion Medicine,SCB Medical College, Cuttack, India Tanveer Rehman, Scientist-B (Medical), ICMR-Regional Medical Research Centre, Bhubaneswar, Department of Health Research, Ministry of Health & Family Welfare, Government of India Sudhira Kumar Parida, Associate Professor, Community Medicine, SCBMedical College, Cuttack, India Mamata Jena, Research Scientist -I, MRU, SCB Medical College, Cuttack, India A. Charles PonRuban, Assistant Professor of Community Medicine,Tirunelveli medical college, Tamil Nadu, India ShantaramanKalyanaraman, Additional Director of Medical Education, Directorate of Medical Education and Research, Chennai, Tamil Nadu, India K. Sunitha, Professor of Community Medicine, Tirunelveli Medical College, Tirunelveli, Tamil Nadu, India Jerin Cherian, Medical Scientist, Indian Council of Medical Research, Department of Health Research, Ministry of Health and Family Welfare, New Delhi, India Tanu Anand, Scientist E (Medical), Clinical Studies & Trials Unit, Division of Development Research, Indian Council of Medical Research, Department of Health Research, Ministry of Health & Family Welfare, New Delhi, India Denny John, Professor, Faculty of Life and Allied Health Sciences, MS Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India Name and contact information for the trial sponsor {5b} Dr. Jerin Cherian, Medical Scientist, Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, New Delhi, Email: [email protected] Role of sponsor {5c} Jerin Cherian & Tanu Anand is employed with ICMR who have funded the study, have contributed to protocol development, and agreement to the final manuscript. Study sponsor does not have any role in the study design, collection, management, analysis and interpretation of data. Introduction Background and rationale {6a} According to the Indian Council of Medical Research (ICMR) State-Level Disease Burden initiative (2017), the percentage of mortality in India attributable to non-communicable diseases (NCDs) rose from 37.9% in 1990 to 61.8% in 2016. (1) The four major causes of NCD deaths are: Coronary Heart Disease, Stroke and Hypertension (45%), Chronic respiratory disease (22%), Cancers (12%) and Diabetes (3%). (2) Despite the fact that drugs work well to treat these diseases, there are several factors which lead to treatment failure. Factors contributing towards treatment failure are unhealthy diet, lack of physical activity and use of tobacco and alcohol along with poor treatment adherence. (2,3) Globally, over 50% of patients do not adhere to their medicines, leading to treatment failure. (4) The WHO defines adherence as the extent to which a person’s behaviour – taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider. (4) Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments. (5)Multiple barriers, pertaining to various socio-cultural and scientific factors, frequently make it difficult for patients to adhere to treatment regimens in the best possible way. These includesocial and economic factors, the healthcare team and system, disease-related factors, disease features, and disease treatments. If patient's adherence to treatments is to be improved, the factors associated with these problems must be addressed. (4) Patient-tailored interventions, healthcare professionals trained in adherence, and team building with community and patients’ organizations have been shown to improve adherence. (4) Peer support, an example of team building, can be a critical and effective strategy for health care and sustained behaviour change for people with, or at risk for, chronic diseases and other conditions. (4) Peers can be defined as people sharing similar experiences or backgrounds. (6,7) The objectives of these support systems are: – to promote the exchange of experiences of dealingwith a disease and its treatment, to provide comprehensive medical information, and to promote patients’ responsibility for their own care. (4) Numerous studies have been conducted around the world, including in our country, to determine the efficacy of peer group therapy in treating psychiatric disorders, cancers, and infectious diseases like human immunodeficiency virus (HIV) and tuberculosis. (8,9,10,11,12) However, there is a dearth of information regarding the effectiveness of such modalities among diabetic and hypertensive individuals in LMICs. As diabetes and hypertension are highly prevalent in India, adherence to medicines is crucial for bringing down the disease burden. In a developing nation like ours, sustained peer group therapy using community-based participatory research (CBPR) model can significantly contribute to enhancing adherence in an affordable and long-lasting manner. (13) CBPR models have also improved health literacy in diabetes and mental health in China and India.(13,14) As a community health program, our intervention aims to: (i) improve medication adherence in patients with diabetes and/or hypertension, (ii) improve health literacy in patients with diabetes and/or hypertension, (iii) improved clinical outcomes in terms of HbA1cand blood pressure in patients with diabetes and/or hypertension, (iv) improve quality of life among patients with diabetes and/or hypertension, and (v) improve utilisation of healthcare services by patients with diabetes and/or hypertension. Our hypothesis is that, using a cluster controlled randomized controlled trial, the intervention compared to those receiving standard treatment care will improve medication adherence and health literacy among patients with diabetes and/or hypertension. Measuring the efficiency and implementation process of the intervention will generate valuable insights on how we might sustain the impact of the intervention when delivered to a larger population. Objectives {7} Primary objective To assess the effectiveness of community-based participatory research (CBPR) for improving medication adherence in diabetic and/or hypertensive patients in comparison to control group. Secondary objective To measure the effects of using CBPR for improving medication adherence among diabetes and hypertension patients on individual outcomes such as personal health literacy, quality of life, and service user satisfaction. To assess the effects of using CBPR for improving adherence to drugs among diabetes and hypertension patients on implementation outcomes such as acceptability and adoption. To assess the cost-effectiveness and return-of-investment of the intervention (i.e. CBPR for improving medication adherence among diabetes and hypertensive patients) Trial design {8} It is a multi-center cluster randomized controlled trial (MC-CRCT) with a 1:1 allocation ratio. The intervention group participants will receive peer-group therapy sessions on medication adherence using CBPR model. Participants in the control group will receive standard care offered by private or public healthcare providers. The authors hypothesize that CBPR model using peer-group therapy sessions is superior to standard care for medication adherence among adult patients with diabetes and/or hypertension. Methods: Participants, interventions and outcomes Study setting {9} The intervention will be implemented across 04 sub-blocks (64 villages) across 04 districts in East, West, North, and South zones of India. The implementation will be first conducted in the West zone, which will act as coordinating site for the effectiveness study component and later replicated in other zones for the implementation component. In West zone, study will be conducted in Sanwer block of Indore district, Madhya Pradesh state, that has 25 PHCs and 8 CHCs. This district has a population of 32,76,697 with 16,99,627 males and 15,77,070 females, rural population of 8,48,988, literacy rate of 80.87, and 1,36,449 population employed in agricultural sector. Sanwer has a population of 1,97,835 with 1,02,874 males and 94,960 females, rural population of 1,71,292, and 23,740 population employed in agricultural sector.In East Zone, study will be conducted in Tigiria block of Cuttack district, Odisha state, which has 4 primary healthcare centre (PHCs) and 2 community health centres (CHCs). This block has a population of 76,379 with 40,026 males and 36,349 females, with rural population of 66,582, literacy rate of around 73.2% and 4049 population employed in agricultural sector. In North Zone, study will be conducted in Haroli block, Una district, Himachal Pradesh state, with 7 PHC and 4 CHC. This block has a population of 1,12,592 with 57,128 males and 55,464 females, rural population of 1,12,592, literacy rate of 61%, and 15,074 population employed in agricultural sector. In South zone study will be conducted in Pappakudiblock of Tirunelveli district, Tamil Nadu, that has 3 PHCs. Pappakudi has a population of 1,04,380 with 51,720 males and 52,660 females, with rural population of 80,333, literacy rate of around 69.31% and3500 population employed in agriculture sector. Eligibility criteria {10} The study samples will consist of adult community members with diabetes and/or hypertension, are on medications residing in the target districts who provide informed consent. Inclusion criteria Diagnosed case of diabetes and/or hypertension and are on medication(s). Male or female aged 18 years or more. Resident of village during the baseline survey. Has no plans to migrate in next 12 months from the date of initiation of intervention. Exclusion criteria Bedridden persons who cannot provide informed consent or unable to answer the questions Pregnant or lactating mothers Persons with a terminal medical condition or with cognitive impairment Who will take informed consent? {26a} Written informed consent will be obtained from the study participants by PI/Co-PI or health counsellor. Participants will receive a participant information sheet outlining the rationale for the study, details on interventions, the steps and protocols to be followed throughout the study, potential side effects and risks, benefits, a confidentiality statement, the option to withdraw from the study at any time, and the investigators' contact information. Additional consent provisions for collection and use of participant data and biological specimens {26b} Blood samples will be collected to assess HbA1c among patients with DM and HTN after obtaining consent. These samples will be tested using point-of-care devices and will not be stored. We will request consent for review of participants’ medical records, and for the collection of blood samples to assess HbA1c among the patients with type 2 diabetes. But this trial does not involve collecting biological specimens for storage. Interventions Explanation for the choice of comparators {6b} Studies have shown that patient-tailored interventions using healthcare professionals trained in adherence, and team building with community and patients’ organizations have been shown to improve medication adherence among people with, or at risk for, chronic diseases and other conditions. Peer group therapy have been used in treating psychiatric disorders, cancers, and infectious diseases like human immunodeficiency virus (HIV) and tuberculosis. The dearth of information regarding the effectiveness of peer-group therapy among diabetes and hypertensive individuals in LMICs, and high prevalence of these diseases in the Indian context, prompted us to implement this cluster-controlled multicenter study. We envisage that using community based participatory research (CBPR) methods for sustained peer group therapy could make a significant contribution to enhancing medication adherence in India in an affordable and long-lasting manner. Intervention description {11a} The implementation will be conducted in four phases, including the intervention of peer group therapy as shown in Figure 1. Phase 1: Planning The process of developing the intervention started with the initial concepts based on the available literature & interaction with healthcare professionals working in rural areas. The objectives of the interventions included educating patients on adherence and associated challenges, providing daily management help, connecting them to clinical and community resources, and providing ongoing social and emotional support through peer group therapy. Development of peer group therapy sessions and education materials - There will be eighteen face-to-face sessions, twice a month for the first six months and then once a month for the following six months. The agenda of these sessions are WHO adherence principles, barriers, methods for overcoming such challenges and providing daily management help. These sessions will be categorized under five modules which are: understanding disease- and medication-related information, information about disease and medication, tackling misinformation, concept of adherence, and, institutionalizing the intervention on long-term basis. Each Session will start with re-cap of the previous session and questions on adherence/NCDs followed by delivery of content for the day using teach-back technique. The last session of each module will be goal setting; and learnings. Intermediate feedback will be collected from the participants and learning from them will be incorporated in future sessions. Details of eighteen face-to-face sessions are included in Appendix-1. Advocacy meetings: Line listing of villages will be done and selected villages will be stratified based on population cut-off of 2500. These villages will be randomized into intervention & control clusters as shown in Figure 2. To identify the eligible participants and peer educator from each cluster, a meeting will be organised with the head of the villages and the responsible NCD clinic. Under the National Programme for prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and stroke (NPCDCS)Government of India has established NCD clinics for the screening, management, counselling, andother aspects of non-communicable disease management. These clinics at community health centres level maintain individual diagnosis, treatment and referral records on the patient chronic disease card, with verbal and pictorial advice for the patient. Patients who are all eligible for the study will have their information collected from NCD clinics. Peer educators will be selected from the community. These clinics will be used for intervention implementation site. Selection & training of team : Our team will consist of principal investigator (PI), co-principal investigators (Co-PI), health counsellor (trained psychologist/clinical pharmacologist/clinical pharmacist) and project coordinator along with a peer educator from the community. Health counsellor& project coordinator will be recruited and trained by the PI & Co-PIs. Health counsellor will deliver the intervention initially & project coordinator will assist the training programs and meetings, supporting health counsellor and record keeping. Peer educator will be recruited by the investigators on the advice of village head & NCD clinic in-charge. He should be a member of community with an interest in health care and community, willingness to learn, and leadership qualities. A strong commitment to work in the community was identified as an important criteria for the selection of all the team members. Phase 2: Baseline evaluation and Implementation of intervention at coordinating site In the Phase 2, study will be implemented at co-ordinating site (SAMC & PGI, Indore) after obtaining the ethics committee approval. Written informed consent will be obtained from the study participants by PI/Co-PI or health counsellor. Participants will receive a participant information sheet (PIS) outlining the rationale for the study, details on interventions, the steps and protocols to be followed throughout the study, potential side effects and risks, benefits, a confidentiality statement, the option to withdraw from the study at any time, and the investigators' contact information. The baseline survey will be done at T0 visit which will include questionnaires to assess degree of adherence, health literacy and quality of life. It will be performed by trained health counsellor who have undergone training. Questions will be explained to each participant to get familiar with the contents, instructions for filling them out will be given and the responses will be recorded. Special instructions would be given not to ask or consult a colleague while answering the questionnaire. After completion of baseline survey at all clusters, intervention will be implemented in intervention clusters for 12 months. All the participants in both intervention and control arm will be permitted to used standard treatment for diabetes & hypertension. For the 1st 6 months, sessions will be given twice a month followed by once a month for next 6 month. Control group (wait list group) will be given intervention after the completion of 12-month session in intervention group. This will not be included for data analysis. Table 1 shows the timepoint for the intervention implementation as per SPIRIT reporting guidelines.(15)Mid-term evaluation will be done at T7 and T13 sessions. Phase 3: Interim analysis and Implementation of intervention at collaborative sites Interim analysis will be done after 9 months of intervention at coordinating site. If the analysis shows the expected result (8% difference in clinical outcomes between intervention and control group), study will be implemented at other collaborating site in the same pattern as coordinating site. PI and Co-PIs from collaborating site will be trained by the coordinating site team. A workshop will be conducted for this training at coordinating site. Phase 4: Data analysis and publications After the completion of study at all the collaborating sites, data will be compiled at coordinating site. They will be analyzed and submitted to the ICMR. Results of the study will be published in peer-reviewed journal and will be shared with the participants. All the participants are permitted to use standard care treatment for diabetes or hypertension. Criteria for discontinuing or modifying allocated interventions {11b} This is not applicable as the intervention is aimed to improve medication adherence, so there will no special criteria for discontinuing or modifying allocated intervention. Strategies to improve adherence to interventions {11c} The intervention is designed to enhance medication adherence in individuals with diabetes and/or hypertension, as assessed using the eight-item Morisky Medication Adherence Scale (MMAS-8). (16) Adherence to interventions will be ensured through the selection of peers from the community. Research team members (PI and Co-PI of coordinating site) will be conducting multiple visits to ensure intervention fidelity. Process evaluations will be conducted in conjunction with the intervention through interviews with treating doctors, program staff, peer educators, and target beneficiaries at regular intervals during the intervention. The analysis of these interviews will be used by program staff to improve adherence to interventions. Relevant concomitant care permitted or prohibited during the trial {11d} Concomitant care permitted are medicines and other cares that patients' doctors provide to treat their hypertension and diabetes or any other associated illness. Provisions for post-trial care {30} This is a non-pharmacological intervention; therefore, there are no specific post-trial care provisions. Outcomes {12} The measure of drug adherence for hypertension and/or diabetes, as determined by the self-reported Morisky Medication Adherence Scale (MMAS-8) at baseline, midterm, and at the end, is the study's outcome variable. (16) When converted into a dichotomous variable, a score of more than 6 denotes “good adherence.” Age, gender, total number of antihypertensive and/or antidiabetic drugs used (regardless of medication class), duration using these drugs, educational attainment, marital status, occupation, monthly household income, self-perceived health status, systolic and diastolic blood pressure and/or HbA1c, and other independent variables were all controlled while doing the analysis. A standardised methodology for the detection of arterial hypertension and/or diabetes will be used to assess blood pressure and/or HbA1c. For Indore and Himachal Pradesh sites, MMAS-8 Hindi version would be used. For the sites in Odisha and Tamil Nadu,, translation versions of MMAS-8 tool will be used using ISPOR best practices guidelines. (17) The secondary outcomes include personal health literacy improvements due to the intervention measured using All Aspects of Health Literacy Scale(AAHLS).(18)Our choice for identifying health literacy as a secondary outcome is based on the conceptual causal model linking health literacy to health outcomes as documented in Paasche-Orlow& Wolf (2007) (Annexure I). (19) Other secondary outcomes include improvement in clinical outcomes measured in terms of HbA1c and blood pressure in patients with diabetes and/or hypertension in both the groups. HbA1c and blood pressure will be measured at baseline and will be compared from midline and endline measurements. Improvements in medication adherence is expected to improve quality of life among persons with diabetes and/or hypertension and this will be assessed using a validated version of the EURO Quality of life-5D (EQ-5D) in the local language of the target sub-districts. (20) User satisfaction with the intervention will be assessed using a validated version in the local language of the Patient Satisfaction Questionnaire Short-Form (PSQ-18). (21) Additional outcomes will include costs of intervention, cost-consequence based on the observed results within the trial period, and (2) cost-effectiveness analysis where differences between groups in the trial will be extrapolated to the longer term where appropriate. Fidelity of intervention will be monitored using the Normalisation Process Theory framework. Participant timeline {13} Table 1: Timepoint for the intervention implementation Sample size {14} The required sample size will be determined by focusing on the primary objective of this trial, which was to evaluate the effect of peer group therapy on medical adherence in diabetics and hypertensives in rural India. Sample size was calculated using the parameters of the study published by Amir et al (2021) and Abdullah et al (2022) on hypertensive and diabetes medication adherence population, respectively. (22,23) R software version 4.1.3 was used for the sample size calculation. Proportion of hypertension and Type-II diabetes medication adherence among 18 years and above was 57.3% and 53.4%, respectively in the control group. (24) Sample sizes of 1088 in control group and 1088 in intervention group, which were obtained by sampling 32 (𝑚) clusters with 34 subjects each in control group and 32 clusters with 34 subjects each in intervention group, achieve 90% power (𝛽) and 5% (𝛼) (one sided) significance level, allowing for intra-cluster correlation (ICC) 0.02 (𝜌) to detect a difference between the intervention and control group proportions of 8% [pI = 61.4%] through the formula: (22,23,24) Considering the 20% loss to follow up, we anticipated the final sample size of ~2880 from 4 participating centers, i.e., 360 per group and per center to complete sample size. • Total number of clusters in Control group= 32 [Village [4]X Population Group [2]X Centre [4]] = Total number of clusters Intervention group • Total participants per cluster in Control group per center= 360 [ i.e., 45 from each of Village [8]] = Total participants per cluster in Intervention group • Total participants= 2880 [720 X 4 Centers] Recruitment {15} The village on the list will be visited by our team. Principal Investigator (PI) and Co-Principal Investigator (Co-PI) in charge of implementation will meet the heads of the village and the NCD clinic. Patients who are all eligible for the study will have their information collected. We will only enroll patients who agree to participate in the trial. Assignment of interventions: allocation Sequence generation {16a} Allocation of intervention and sequence generation will be conducted as follows. Codes will be randomly assigned to the two interventions (CBPR and control groups) namely A and B. In the next step, randomization list will be generated using RANDOM ALLOC software. 4 centers will be randomized into 2 study groups (A and B). Each center will be allocated random numbers ranging from 1 to 4 using computer random number generators. Following randomization, participants and caregivers will be aware of whether they are in an intervention village or control village. Participants who fulfil the eligibility criteria and signed the informed consent will be included in the study. Concealment mechanism {16b} Due to the nature of the intervention (peer-group) blinding is not possible for this trial. However, study site allocation will be done only after completing baseline assessment and agreements with sites to participate. A centralised online computer-generated system (Sealed Envelope) will conceal allocation for the study. The allocation sequence is provided to the PI/Co-PI at each site via this secure system. Once participants are randomised to a treatment arm, PI/Co-PI in charge of implementation will meet the heads of the village and the NCD clinic. Patients who are all eligible for the study will have their information collected and those patients who agree to participate in the trial will be included. The system has restricted access of the allocation, which is only assigned to specific personnel, i.e.unblind statistician.All other study personnel involved in direct study conduct and participants are completely blinded to the randomisation system. It will not be possible for the study team to determine treatment allocation using laboratory data during the trial period. Implementation {16c} A statistician who will be unaware of the group assignment will assign randomly selected villages to each stratum using computer generated random number, and also assign random treatment allocation. The enrolment will be by done by the Co-PI and the Co-PI will assign village as it is a cluster randomized trial. Assignment of interventions: Blinding Who will be blinded {17a} Data analysts (biostatisticians) will be blinded. The patients, their caregivers and outcome assessors are not blinded. Procedure for unblinding if needed {17b} In this study, the patients, their caregivers and outcome assessors will not be blinded. Only the data analyst will be blinded. The data analyst will be unblinded if there are any outlier biochemical values which requires immediate action so that the patient can be intimated. Data collection and management Plans for assessment and collection of outcomes {18a} The primary outcome is the improvement in medication adherence in diabetes and/or hypertension as measured using the eight-item Morisky Medication Adherence Scale (MMAS-8). (16) The MMAS-8 consists of eight questions, first seven items having a dichotomous answer (yes/no) that indicates adherence or non-adherent behaviour. For item 8, a patient can choose an answer on a 5-point Likert scale, expressing how often happens that a patient does not take his medications. MMAS-8 scores can range from 0 to 8 points. Cut-off values for categorizing patients as having a high, medium or low adherence rates are chosen. For Indore site, MMAS-8 Hindi version would be used. For the sites in Odisha and Tamil Nadu, translation versions of MMAS-8 tool will be used using ISPOR best practices guidelines. (17) We will be using CDC’s definition of personal health literacy, which is the degree to which individuals can find, understand, and use information and services to inform health-related decisions and actions for themselves and others. (25) Personal health literacy improvements due to the intervention will be measured using All Aspects of Health Literacy Scale(AAHLS). (18) It measures patients' functional, communicative, and critical health literacy in the context of basic healthcare. There are thirteen items in all, and item number 1 to 10 are rated on a 3-point Likert scale with the prompts "rarely", "sometimes", and "often" . Whereas item number 11–13 are analyzed on a 2-point Likert scale in a descriptive manner. Higher total scores indicate a higher level of health literacy. Improvement in clinical outcomes will be measured in terms of HbA1c and blood pressure in patients with diabetes and/or hypertension in both the groups. HbA1c and blood pressure will be measured at baseline and will be compared from midline and endline measurements. For HbA1c measurement, 5 ml of blood will be collected from participants by venipuncture after taking consent in EDTA tube. Samples will be carried to analysis center in icepack (2-8 degree Celsius) andwill be analyzed in Trivitron nano H5 machine using High Performance Liquid Chromatography (HPLC) technique. Calibration of the instrument will be as per manufacturer’s guidelines and lab quality assurance. Blood pressure measurement will be done using digital sphygmomanometer and will be measured as per Centers for Disease Control and Prevention (CDC) guideline. Calibration of the instrument will be as per manufacturer’s guidelines. Improvement in quality of life among persons with diabetes and/or hypertension will be assessed using a validated version of the EURO Quality of life-5D (EQ-5D) in the local language of the target sub-districts. The EQ-5D’s descriptive system is a preference-based Health Related Quality of Life (HRQoL) measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression measured at 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A lower score indicates a better quality of life. (20) User satisfaction with the intervention will be assessed using a validated version in the local language of the Patient Satisfaction Questionnaire Short-Form (PSQ-18). (21) The PSQ-18 contains 18 times tapping each of the seven dimensions of satisfaction with medical care measured by the PSQ-III: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Subjects have five options when answering each question: Strongly agree, Agree, Uncertain, Disagree and Strongly Disagree, with 1-5 points for each answer, where 5 mean the highest satisfaction. (21) For cost-consequence and cost-effectiveness analyses, costs in both arms will be estimated from a societal perspective. Costs will be accounted under two categories: 1. Total cost of the intervention, and 2. Treatment cost of diabetes and/or hypertension. Treatment costs will be categorized as direct medical costs, direct non-medical costs, and indirect costs. Direct medical costs will include out-of-pocket expenses incurred to seek treatment (e.g. diagnostic tests, fees for consultation in clinics, traditional healers, hospitals, bed day charges at a public or private health facility). Direct non-medical costs will include the amount spent for traveling to the health facility for the patient and accompanied persons for treatment, the amount spent on meals/food taken while waiting for treatment, expenses for overnight accommodation for seeking care, etc. Indirect costs represent the opportunity cost for the patient and their household members’ time related to diabetes and/or hypertension. Cost data will be collected at baseline and each month from all study participants. Time spent by the peer educators will be obtained from the program implementation data. The minimum wage rate of the state will be used to value their time. Total hours spent on the program will be multiplied by hourly wage (obtained from the minimum wage rate) to get the time cost of the peer educators. Benefits will be considered based on improved health, functioning, participation, productivity, increased saving and investment, reduced informal caregiving, and health and welfare services. Lost workdays before and after the intervention will be obtained through the WHO-DAS 12 questionnaire and will be linked to the minimum wage rate to estimate the aggregate effect. (26) Process evaluation will be conducted using a mix of questionnaires, interviews, and focus groups. The process evaluation will be used to understand: The participants’ experiences of the intervention and its different components; any discrepancies between expected and observed outcomes; the influence of intervention components and context of the observed outcomes; sustainability; the extent of any contamination between intervention and control; and any unexpected events arising from participation. Self-reported questionnaires will be provided to study participants to evaluate their opinions of the various intervention components. Interviews and focus groups with study participants (sub-sample) will further examine engagement in the various components of the intervention, along with any barriers or facilitators to participating in the various components. Focus groups with study participants (sub-sample) will further examine the intervention implementation and participants’ experiences of delivery. All interviews and focus groups will be audio-recorded and transcribed verbatim. Throughout the intervention, the fidelity of the intervention implementation will be monitored using the Normalisation Process Theory Framework.(27) Observations will take place in intervention arms across clusters to assess whether the intervention was delivered as expected and receipt of the intervention by the attendees. During the observations, a case report form will also be completed. The case report form will combine an ‘adherence measure’ to capture delivery (mode of delivery (dose/duration/content) and use of resources (materials/activities). Plans to promote participant retention and complete follow-up {18b} All efforts will be made to retain all participants in the study. Due to the institutions providing medical and clinical care in the respective study sites, there is a good rapport with the study group, local self-government, and frontline health workers. Loss to follow-up may result from migration to their children’s places of living or death or for other reasons. The characteristics of the patients who drop out will be recorded and compared to those who are in the study. Data management {19} All the PIs and Co-PIs along with data entry operators will have access to the research data. All the qualitative and quantitative data will be stored in paper format as well as electronically. The paper copies and documents will be kept in closed cabinets at the individual sites under lock and key and will have limited access to the data management team. The electronic data will be stored on cloud using a separate google drive account for the purpose of this research with access restricted to the data management team only. Audit trails ofongoing decisions including revision of existing codes and emergent codes will be kept for all interviews. Quality of data will be ensured at every step by the site data operators, PIs and Co-PIs. Strict confidentiality will be maintained while handling the data. The data will be stored for a period of 5 years. The results generated out of this research will be freely shared with public and research community through research publications. Confidentiality {27} Confidentiality of the participants will be ensured during recruitment of the participants, data collection, during transcription, data analysis and during dissemination of research results. It will be done by assigning unique ID to the participants while recruitment and coding them during analysis. This will be stored confidentially before, during, and after the trial. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} The baseline survey will include questionnaires to assess degree of adherence, health literacy and quality of life. It will be performed by trained health counsellor who have undergone training. Questions will be explained to each participant to get familiar with the contents, instructions for filling them out will be given and the responses will be recorded. Special instructions would be given not to ask or consult a colleague while answering the questionnaire. For HbA1c measurement, 5 ml of blood will be collected from participants by venipuncture after taking consent in EDTA tube. Samples will be carried to analysis center in icepack (2-8 degree Celsius) and will be analyzed in Trivitron nano H5 machine using High Performance Liquid Chromatography (HPLC) technique. Calibration of the instrument will be as per manufacturer’s guidelines and lab quality assurance. Blood pressure measurement will be done using digital sphygmomanometer and will be measured as per Centers for Disease Control and Prevention (CDC) guideline. Calibration of the instrument will be as per manufacturer’s guidelines. This trial does not involve collecting biological specimens for storage. In this study, blood samples will be collected to assess random blood sugar and HbA1c. These tests are done using point-of-care devices. The blood samples will not be stored in the current trial. Statistical methods Statistical methods for primary and secondary outcomes {20a} Data will be collected by following the well-structured questionnaire and entered in SPSS. Data will be analyzed using software STATA or SPSS. The intention-to-treat principle will form the basis of the primary analysis. For all patient–related outcome analyses, we will conduct cluster–specific methods. Dichotomous outcomes will be compared between intervention and control group using a chi-square test. Continuous outcomes will be compared between intervention and control using t-test or non-parametric test, and for more than two groups’ comparison ANOVA test/ Krushkal test, and post hoc test for within group’s comparison after more than 2 follow up repeated measures ANOVA test/ Friedman test will be applied. Pre and post interventional comparison will be done using paired t-test / Wilcoxon sign rank test. Multilevel modeling (linear or logistic as appropriate) will be used to compare the primary outcome pre-intervention to post-intervention data between groups while adjusting for potential convariates (age, sex, and co- morbidities or secondary outcomes (blood pressure, random blood sugar, Hba1c levels and quality of life. When the MMAS-8 score is dichotomized (e.g., high adherence vs. low adherence, a multilevel logistic regression model will be used to compare adherence between groups while accounting for clustering within the data. (28,29,30) The Model includes (31): Level 1 (individual level): This includes patient-level factors such as age, gender, socioeconomic status, or duration of illness. Level 2 (cluster level): This includes higher-level factors such as clinics or regions, if the patients are nested within these settings. When the MMAS-8 score is treated as a continuous variable (ranging from 0 to 8), a multilevel linear regression model is appropriate for analyzing adherence.(27, 32) The model includes: Level 1 (individual level): Continuous MMAS-8 scores are modeled at the patient level with covariates such as age, income, or comorbidities. Level 2 (cluster level): Clinics, doctors, or geographic regions where patients are nested are treated as higher-level units, introducing random intercepts (or slopes, if needed). By using multilevel modeling , we can effectively compare adherence outcomes while accounting for the hierarchical structure of the data (e.g., patients nested within clinics), making the estimates more reliable and appropriately controlling for between-group variability. Additionally, a return on investment (ROI) analysis, expressing benefits in monetary terms relative to investments made, and expressing both the costs and the full range of benefits of an intervention in the same units (money), will also be conducted. Within the period of the trial, we will collect resource use estimates from participant questionnaires. These questionnaires will record health resources that the population is likely to use services such as outpatient and any other health services (e.g. laboratory). The within-trial analysis will present incremental results for the primary and secondary outcomes using EQ-5D in both arms and will be compared with the incremental costs measured. While there may be short-term benefits to improving adherence, the longer-term effect on mortality will likely be more important. We will use existing evidence that links short-term trial endpoints and longer-term outcomes. While some existing evidence used covariates to adjust for confounding factors, it is not possible to assess unmeasured confounders. We will use existing evidence to extrapolate costs and effects to a more appropriate time horizon as recommended by Taylor and Elston (2009) and to explain how the relationship of surrogate-final outcomes quantified and explore the uncertainty around the use of the surrogate outcome (i.e., adherence) through sensitivity analysis. (33) If appropriate an Incremental Cost-Effectiveness Ratio (ICER) for the extrapolated period will be reported using the Quality Adjusted Life Year (QALY). Costs and effects will be discounted at 3% as per WHO guidelines but will be the subject of sensitivity analysis to reflect the ongoing uncertainty around appropriate discount rates for public health interventions. Probabilistic sensitivity analysis will be conducted to allow characterization of the uncertainty around the adoption decision which will be depicted using cost-effectiveness acceptability curves. Sensitivity analysis will be performed to determine the robustness of the results to altering certain assumptions such as discount rate, intervention costs, and the robustness of the relationship between adherence and mortality. Being alive and healthy will also be considered valuable and the overall value of a life year will be broken down into its economic (instrumental) and health (intrinsic) elements. Following the approach used in prior ROI analyses in diabetes and/or hypertension, a figure of 0.5 times the per-capita income of India will be considered as the value of a healthy life year. (34) Qualitative interviews will be recorded and analysed thematically, using both inductive and deductive coding approaches. Two coders will independently code each transcript by identifying emergent themes and interview guides. Broader themes will be broken down into smaller, more specific subthemes until no further subcategories are required. Inter-coder reliability will be assessed; agreement between 66 and 97% will considered as good reliability. Any coding disagreements will be resolved through project team discussions and where required, a third independent coder will re-code the transcript. Questionnaire data will be summarized using frequency counts and means (+/- SD) where appropriate. Audio-recordings of interviews and focus groups will be transcribed verbatim and analysed using framework analysis using the Normalisation Process Theory as the overarching framework. (27) Interim analyses {21b} Interim analysis will be done at 9 th month of intervention at the coordinating site. Since the risk due to the intervention (CBPR method) is minimal or none, interim analysis, and stopping guidelines have not been prescribed by the ethical committee and therefore will not be any stopping guidelines. Methods for additional analyses (e.g. subgroup analyses) {20b} Subgroup analysis will not be carried out. However, for the primary and secondary outcome variables, covariates such as age, sex, and co-morbidities will be considered as potential confounders in the mixed effect model analysis. Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} Nonadherence will be managed by the intention to treat analysis and if there are too many missing data, imputations using Markov Chain Monte Carlo (MCMC) for missing data problems arising due to the longitudinal nature of the study will be considered. Mixed method analysis will be considered for intention to treat analysis. Also depending on the percentage of data missingness and assumption for data missing in the study variables, appropriate missing data imputation technique will be used. Plans to give access to the full protocol, participant level-data and statistical code {31c} Full protocol can be given. Full dataset can be given with the permission of the participating institutions, and ICMR. Oversight and monitoring Composition of the coordinating centre and trial steering committee {5d} Principal Investigators and Co-PIs will form a project management unit (PMU) andwill meet every month online to discuss the progress of the project and the PI will report quarterly to the oversight steering committee. Recruitment, follow-up rates, and missing data will be discussed at monthly review meetings between data manager and field data collectors. The oversight steering committee will be consisting of senior members from various institutions including Dean or heads of collaborating institutions, who are not directly involved with the project. Their objective is to ensure that the PI gets the strategic support for all the activities of the research project. Composition of the data monitoring committee, its role and reporting structure {21a} The PI will be conducting all aspects of data collection and management. All participants will be given a unique study Participation Identification Number (PIN). Data will be entered under this identification number onto the laptop of the PI that will be controlled with a unique username and password. Once data entry is complete, the database will be locked prior to any trial analysis. Following consent, identifiable (consented participants only) data linked to the PIN will be held locally at the research office in a locked filing cabinet. After completion of the study, the identification, screening and enrolment logs will be securely archived at the research office for 5 years, unless otherwise advised by the university. Adverse event reporting and harms {22} As this study is measuring adherence of an intervention, no adverse events or serious adverse events and harms from the intervention are anticipated. We will consider adverse events as stopping treatment altogether, or any adverse events arising due to the medications. A protocol for reporting and recording of adverse events is provided in the Additional file. All team members will be trained by the data manager and PI on proper identification, recording, and reporting of adverse events. All adverse events will be tracked as per protocol and reported to the Institutional Ethics Committee within 15 days of occurrence, District Health Authority and Trial Steering Committee. Trial deviations will be reported to the ethical committee. Harms reporting in the final publication will be conducted as per CONSORT Harms 2022 statement. (35) Frequency and plans for auditing trial conduct {23} The meetings of the Project management group, Trial Steering group, independent data monitoring, and Ethics Committee periodically will also serve to audit the trial. Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} Before the start and at the start, there have been some minor modifications which has been updated to the ethical committee and subsequently uploaded in the CTRI. Dissemination plans {31a} The results of the study will be published in standard peer-review journals with authorship as per ICMJE (2023) and CRediT recommendations. Social media and Stakeholder workshops will be used to disseminate the findings. A plain-language summary will be shared with all participants. Discussion This cluster-randomized, multi-centric trial will be one of the unique studies which will be benefitting the community by increasing the drug adherence for chronic conditions using CBPR model. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence. The trial will be using type 2 hybrid effectiveness-implementation design, with the effectiveness study conducted in the West zone of the country and the implementation to be replicated in other 3 zones of India, in the areas with diverse culture and beliefs, which will make the model more generalizable, and will make the evidence applicable for India and South Asia, and similar contexts. A hybrid type 2 design has a dual focus on the clinical intervention and implementation related factors. In hybrid type 2 designs, it is important to have an explicitly described implementation strategy that is thought to be plausible in the real world. Hybrid type 2 designs always need explicit measurement of implementation outcome (e.g., adoption, fidelity) and it is important to be clear about the intervention components versus the implementation strategy components. (36,37) Stepped wedge designs involves implementing an intervention over time in a staggered way usually involving cluster randomization, with collection of observations during a baseline period, and then randomly assigning clusters to receive the intervention at regular intervals. (38) There are significant expected implementation challenges to note. First, the trial involves working with the primary clinics providing NCD screening and detection services, and building an effective partnership with the state government of each state where the project will be implemented will be crucial for its success. Second, medication nonadherence for patients with chronic diseases is extremely common with 40%-50% of patients prescribed medications for management of diabetes and hypertension. (39) There exist treatment-related barriers, such as treatment complexity, side effects (or fear of side effects), inconvenience, cost, and time, and other barriers such as poor practitioner-patient relationship, aspects of which are beyond the scope of the intervention. (40,41) If successful, the medication adherence intervention, using minimum technology and low financial investment has the potential to constitute evidence-based practice for improving medication adherence for diabetes and hypertension in India, and in similar developing countries. The use of CBPR has the potential to improve health literacy among the target populations thus making the study sustainable beyond the project period. The examination of implementation processes throughout the trial will also help in preparing a roadmap for policymakers and researchers to implement and scale-up implement medication adherence interventions in diabetes and hypertension and potentially other non-communicable diseases in other settings. Trial status The current protocol is version 6.0 dated 28/02/2024. The recruitment began on March 01, 2024 and is expected to be complete by July 01, 2025. The submission has been delayed due to unavoidable circumstances such as changes in trial registry and weather. Abbreviations CBPR: Community based participatory research WHO: World health organization MMAS 8: Morisky Medication Adherence Scale 8 AAHLS: All Aspects of Health Literacy Scale ICMR: Indian Council of Medical Research NCD: Non-communicable diseases HIV: Human immunodeficiency virus MRHRU: Model rural health research unit PI: Principal investigator Co-PI: Co principal investigators ICER: IncrementalCost-Effectiveness Ratio CDC: Centers for Disease Control and Prevention HPLC: High Performance Liquid Chromatography QALY: Quality Adjusted Life Year NP-NCD: National Programme for Non-Communicable Diseases Declarations Acknowledgements The authors acknowledge ICMR and Sri Aurobindo Medical College & PGI, Indore for all the support provided for this research. Authors’ contributions PR is the Chief Investigator; conceived the study, led the proposal and protocol development and acquired funding, Methodology, Writing-Original Draft Preparation, Review & Editing AJ- Design of intervention, development of the proposal, acquired funding, Methodology, Writing-Original Draft Preparation, Review & Editing HG & VV are involved as statisticians and will conduct the statistical and qualitative analyses. Writing- Review & Editing DK, AB, SM, TR, SKR, MJ, ACPR, SK, KS and BU will be responsible for implementing intervention at collaborating sites. Writing- Review & Editing JC & TA are attached to ICMR and are research managers to the project, Writing- Review & Editing DJ is lead trial methodologist and for economic evaluation, Writing – Original Draft Preparation, Review & Editing All authors read and approved the final manuscript. Funding This is a ICMR funded research protocol under National task force on Safe and Rational Use of Medicine. Protocol ID is 2023-20019, version 6 dated 28/02/2024. JC & TA is employed with ICMR who have funded the study. JC & TA have contributed to protocol development, and agreement to the final manuscript. The funding institution had no other role in the development of this protocol. Contact Dr. Jerin Cherian, Medical Scientist, Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, New Delhi, Email: [email protected] Availability of data and materials The investigators will have access to the final data set. There are no contractual agreements which limit access to investigators. The investigators in the field collect the data and data will be entered in RedCap software. Any data required to support the protocol can be supplied on request. Ethics approval and consent to participate Ethics committee approval has been obtained from the Institutional Ethics Committee of Sri Aurobindo Medical College & PGI, Indore for protocol version 6 dated 28/02/2024. Written, informed consent to participate will be obtained from all participants. Consent for publication Informed consent has been obtained and the model consent form can be made available. No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Competing interests The authors declare that there are no competing interests References Ministry of Health and Family Welfare. https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1796435#:~:text=The%20four%20major%20NCDs%20are,use%20of%20tobacco%20and%20alcohol. Accessed 17 June 2023 Burden of NCDs and their risk factors in India. http://www.searo.who.int/india/topics/noncommunicable_diseases/ncd_situation_global_report_ncds_2014.pdf. 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Table Table 1: Timepoint for the intervention implementation TIMEPOINT STUDY PERIOD Session (T0) Session (T1-T6) Session (T7) Session (T8-T12) Session (T13) Session (T14-T17) Session (T18) ENROLMENT Eligibility screen Informed consent Allocation INTERVENTIONS Intervention group Control group ASSESSMENTS Primary outcome Medication adherence (DOSE nonadherence scale) Secondary outcomes Health literacy (STOFHLA test) Clinical outcome (Hb1AC, blood pressure) Quality of life (EQ5-D scale) Service user satisfaction (PSQ-18) Economic Questionnaire Supplementary Files SPIRITchecklist.docx Appendix.docx Cite Share Download PDF Status: Published Journal Publication published 06 Nov, 2025 Read the published version in Trials → Version 1 posted Reviewers agreed at journal 14 Aug, 2025 Reviewers invited by journal 14 Aug, 2025 Editorial decision: Major revision 14 Aug, 2025 Editor assigned by journal 10 Jul, 2025 First submitted to journal 08 Jul, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5772282","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":500374477,"identity":"b2a2c7b1-262a-4120-9cd0-56936a6ed5c7","order_by":0,"name":"Pooja Reddy","email":"","orcid":"","institution":"Sri Aurobindo Institute of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Pooja","middleName":"","lastName":"Reddy","suffix":""},{"id":500374478,"identity":"f786e036-0b05-4ae9-851c-2a0d5388b1b1","order_by":1,"name":"Anuja Jha","email":"","orcid":"","institution":"Sri Aurobindo Institute of Medical 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John","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA4ElEQVRIiWNgGAWjYDCCAwfYGBgMbOr72RuAPAMLYrUUpDHO7DkA0iJBjBYGoJYPhxk3zEgAcYnQwnfw8LHHBQaHmQ0kn1/d8KNAgoG/vTsBrxbJA8fSjWcYpLOZS+eU3ewBOkzizNkNeLUYHDhjJs1jYM1jOTsn7QYPUIuBRC5RWpglDG6eSbv5hwQtzgYGN9iP3SbKFqBf0oBa0hIke3LYbssYSPAQ9AvfjcPHpHn+2CTwsx9/dvPNHxs5/vZe/FoYJA7AWDwGYBK/chDgb4Cx2B8QVj0KRsEoGAUjEgAA2oNLIr7w3PAAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-4486-632X","institution":"MS Ramaiah University of Applied Sciences","correspondingAuthor":true,"prefix":"","firstName":"Denny","middleName":"","lastName":"John","suffix":""}],"badges":[],"createdAt":"2025-01-06 09:03:27","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5772282/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5772282/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-025-09209-7","type":"published","date":"2025-11-06T15:57:19+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":89657523,"identity":"c097ea2a-582a-428e-937d-aeb087e98d31","added_by":"auto","created_at":"2025-08-22 10:35:36","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":95705,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version.\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-5772282/v1/67a851dcff18be6a26e2300c.jpg"},{"id":89654709,"identity":"e57a49c2-6f6d-4b1e-b393-19170e55f270","added_by":"auto","created_at":"2025-08-22 10:19:36","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":305250,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version.\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-5772282/v1/7313d6b51e5e20adf718dca8.png"},{"id":95564003,"identity":"36fbf735-4742-4c46-b83d-844a6bc617a6","added_by":"auto","created_at":"2025-11-10 16:06:20","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2230720,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5772282/v1/fe2d1883-266f-4d3c-a939-efe1c615580b.pdf"},{"id":89654705,"identity":"e5ac9765-1e43-4340-a4e5-5f35136edf71","added_by":"auto","created_at":"2025-08-22 10:19:36","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":41349,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITchecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-5772282/v1/77d3ff84a6b6fecae2bc0ada.docx"},{"id":89654710,"identity":"00b56c22-9b57-4adc-9325-eb050c30b59c","added_by":"auto","created_at":"2025-08-22 10:19:36","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":292457,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix.docx","url":"https://assets-eu.researchsquare.com/files/rs-5772282/v1/9f680b23db9044295b9b1295.docx"}],"financialInterests":"","formattedTitle":"Effectiveness of peer-group therapy using community based participatory research model on medication adherence among patients of diabetes and/or hypertension: Study protocol for a multi-centercluster randomized trial in rural settings across India (PARTICIPATE study)","fulltext":[{"header":"Administrative information","content":"\u003cp\u003eNote: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"639\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eTitle {1}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eEffectiveness of peer-group therapy using community based participatory research model on medication adherence among patients of diabetes and/or hypertension: Study protocol for a multi-center cluster randomized trial in rural settings across India (PARTICIPATE study)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eTrial registration {2a and 2b}.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eThe registration number for this trial is CTRI/2024/01/061939\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eProtocol version {3}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eVersion 6.0,28 February 2024\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eFunding {4}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eFinancial support from Indian Council of Medical Research (ICMR) under National task force on Safe and Rational Use of Medicine.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eAuthor details {5a}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003ePooja Reddy, Professor and Head, Dept. of Pharmacology, Sri Aurobindo Medical College and PGI, Indore, MP, India-453555\u003c/p\u003e\n \u003cp\u003eAnuja Jha, Associate Professor, Dept. of Pharmacology, Sri Aurobindo Medical College and PGI, Indore, MP, India-453555\u003c/p\u003e\n \u003cp\u003eHarshal Gupta, Professor, Dept. of Community Medicine, Sri Aurobindo Medical College and PGI, Indore, MP, India-453555\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eVivek Verma, Assistant Professor, Department of Statistics, Assam University, Silchar, Assam\u003c/p\u003e\n \u003cp\u003eDinesh Kumar, Professor, Department of Community Medicine, Dr. Rajendra Prasad Government Medical College, Kangra, Tanda, Himachal Pradesh, India\u003c/p\u003e\n \u003cp\u003eAvi Kumar Bansal, Scientist E, National JALMA Institute for Leprosy and Other Mycobacterial Diseases, Tajganj, Agra, India\u003c/p\u003e\n \u003cp\u003eSmita Mahapatra, Nodal Officer, MRU, Prof and HOD, Transfusion Medicine,SCB Medical College, Cuttack, India\u003c/p\u003e\n \u003cp\u003eTanveer Rehman, Scientist-B (Medical), ICMR-Regional Medical Research Centre, Bhubaneswar, Department of Health Research, Ministry of Health \u0026amp; Family Welfare, Government of India\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eSudhira Kumar Parida, Associate Professor, Community Medicine, SCBMedical College, Cuttack, India\u003c/p\u003e\n \u003cp\u003eMamata Jena, Research Scientist -I, MRU, SCB Medical College, Cuttack, India\u003c/p\u003e\n \u003cp\u003eA. Charles PonRuban, Assistant Professor of Community Medicine,Tirunelveli medical college, Tamil Nadu, India\u003c/p\u003e\n \u003cp\u003eShantaramanKalyanaraman, Additional Director of Medical Education, Directorate of Medical Education and Research, Chennai, Tamil Nadu, India\u003c/p\u003e\n \u003cp\u003eK. Sunitha, Professor of Community Medicine, Tirunelveli Medical College, Tirunelveli, Tamil Nadu, India\u003c/p\u003e\n \u003cp\u003eJerin Cherian, Medical Scientist, Indian Council of Medical Research, Department of Health Research, Ministry of Health and Family Welfare, New Delhi, India\u003c/p\u003e\n \u003cp\u003eTanu Anand, Scientist E (Medical), Clinical Studies \u0026amp; Trials Unit, Division of Development Research, Indian Council of Medical Research, Department of Health Research, Ministry of Health \u0026amp; Family Welfare,\u0026nbsp;New Delhi, India\u003c/p\u003e\n \u003cp\u003eDenny John, Professor, Faculty of Life and Allied Health Sciences, MS Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eName and contact information for the trial sponsor {5b}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eDr. Jerin Cherian, Medical Scientist, Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, New Delhi, Email: [email protected]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eRole of sponsor {5c}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eJerin Cherian \u0026amp; Tanu Anand is employed with ICMR who have funded the study, have contributed to protocol development, and agreement to the final manuscript. Study sponsor does not have any role in the study design, collection, management, analysis and interpretation of data.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003e\u003cstrong\u003eBackground and rationale {6a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAccording to the Indian Council of Medical Research (ICMR) State-Level Disease Burden initiative (2017), the percentage of mortality in India attributable to non-communicable diseases (NCDs) rose from 37.9% in 1990 to 61.8% in 2016. (1) The four major causes of NCD deaths are: Coronary Heart Disease, Stroke and Hypertension (45%), Chronic respiratory disease (22%), Cancers (12%) and Diabetes (3%). (2) Despite the fact that drugs work well to treat these diseases, there are several factors which lead to treatment failure. Factors contributing towards treatment failure are unhealthy diet, lack of physical activity and use of tobacco and alcohol along with poor treatment adherence. (2,3)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eGlobally, over 50% of patients do not adhere to their medicines, leading to treatment failure. (4) The WHO defines adherence as the extent to which a person\u0026rsquo;s behaviour \u0026ndash; taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider. (4) Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments. (5)Multiple barriers, pertaining to various socio-cultural and scientific factors, frequently make it difficult for patients to adhere to treatment regimens in the best possible way. These includesocial and economic factors, the healthcare team and system, disease-related factors, disease features, and disease treatments. If patient\u0026apos;s adherence to treatments is to be improved, the factors associated with these problems must be addressed. (4)\u003c/p\u003e\n\u003cp\u003ePatient-tailored interventions, healthcare professionals trained in adherence, and team building with community and patients\u0026rsquo; organizations have been shown to improve adherence. (4) Peer support, an example of team building, can be a critical and effective strategy for health care and sustained behaviour change for people with, or at risk for, chronic diseases and other conditions. (4) Peers can be defined as people sharing similar experiences or backgrounds. (6,7) The objectives of these support systems are: \u0026ndash; to promote the exchange of experiences of dealingwith a disease and its treatment, to provide comprehensive medical information, and to promote patients\u0026rsquo; responsibility for their own care. (4)\u003c/p\u003e\n\u003cp\u003eNumerous studies have been conducted around the world, including in our country, to determine the efficacy of peer group therapy in treating psychiatric disorders, cancers, and infectious diseases like human immunodeficiency virus (HIV) and tuberculosis. (8,9,10,11,12)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHowever, there is a dearth of information regarding the effectiveness of such modalities among diabetic and hypertensive individuals in LMICs. As diabetes and hypertension are highly prevalent in India, adherence to medicines is crucial for bringing down the disease burden.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn a developing nation like ours, sustained peer group therapy using community-based participatory research (CBPR) model can significantly contribute to enhancing adherence in an affordable and long-lasting manner. (13) CBPR models have also improved health literacy in diabetes and mental health in China and India.(13,14) As a community health program, our intervention aims to: (i) improve medication adherence in patients with diabetes and/or hypertension, (ii) improve health literacy in patients with diabetes and/or hypertension, (iii) improved clinical outcomes in terms of HbA1cand blood pressure in patients with diabetes and/or hypertension, (iv) improve quality of life among patients with diabetes and/or hypertension, and (v) improve utilisation of healthcare services by patients with diabetes and/or hypertension. Our hypothesis is that, using a cluster controlled randomized controlled trial, the intervention compared to those receiving standard treatment care will improve medication adherence and health literacy among patients with diabetes and/or hypertension. Measuring the efficiency and implementation process of the intervention will generate valuable insights on how we might sustain the impact of the intervention when delivered to a larger population.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjectives {7}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePrimary objective\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eTo assess the effectiveness of community-based participatory research (CBPR) for improving medication adherence in diabetic and/or hypertensive patients in comparison to control group.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eSecondary objective\u003c/p\u003e\n\u003col start=\"2\"\u003e\n \u003cli\u003eTo measure the effects of using CBPR for improving medication adherence among diabetes and hypertension patients on individual outcomes such as personal health literacy, quality of life, and service user satisfaction.\u003c/li\u003e\n \u003cli\u003eTo assess the effects of using CBPR for improving adherence to drugs among diabetes and hypertension patients on implementation outcomes such as acceptability and adoption.\u003c/li\u003e\n \u003cli\u003eTo assess the cost-effectiveness and return-of-investment of the intervention (i.e. CBPR for improving medication adherence among diabetes and hypertensive patients)\u0026nbsp;\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eTrial design {8}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIt is a multi-center cluster randomized controlled trial (MC-CRCT) with a 1:1 allocation ratio. The intervention group participants will receive peer-group therapy sessions on medication adherence using CBPR model. Participants in the control group will receive standard care offered by private or public healthcare providers. The authors hypothesize that CBPR model using peer-group therapy sessions is superior to standard care for medication adherence among adult patients with diabetes and/or hypertension.\u003c/p\u003e"},{"header":"Methods: Participants, interventions and outcomes","content":"\u003cp\u003e\u003cstrong\u003eStudy setting {9}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe intervention will be implemented across 04 sub-blocks (64 villages) across 04 districts in East, West, North, and South zones of India. The implementation will be first conducted in the West zone, which will act as coordinating site for the effectiveness study component and later replicated in other zones for the implementation component. In West zone, study will be conducted in Sanwer block of Indore district, Madhya Pradesh state, that has 25 PHCs and 8 CHCs. This district has a population of 32,76,697 with 16,99,627 males and 15,77,070 females, rural population of 8,48,988, literacy rate of 80.87, and 1,36,449 population employed in agricultural sector. Sanwer has a population of 1,97,835 with 1,02,874 males and 94,960 females, rural population of 1,71,292, and 23,740 population employed in agricultural sector.In East Zone, study will be conducted in Tigiria block of Cuttack district, Odisha state, which has 4 primary healthcare centre (PHCs) and 2 community health centres (CHCs). This block has a population of 76,379 with 40,026 males and 36,349 females, with rural population of 66,582, literacy rate of around 73.2% and 4049 population employed in agricultural sector. In North Zone, study will be conducted in Haroli block, Una district, Himachal Pradesh state, with 7 PHC and 4 CHC. This block has a population of 1,12,592 with 57,128 males and 55,464 females, rural population of 1,12,592, literacy rate of 61%, and 15,074 population employed in agricultural sector. In South zone study will be conducted in Pappakudiblock of Tirunelveli district, Tamil Nadu, that has 3 PHCs. Pappakudi has a population of 1,04,380 with 51,720 males and 52,660 females, with rural population of 80,333, literacy rate of around 69.31% and3500 population employed in agriculture sector.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEligibility criteria {10}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study samples will consist of adult community members with diabetes and/or hypertension, are on medications residing in the target districts who provide informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eInclusion criteria\u003c/em\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eDiagnosed case of diabetes and/or hypertension and are on medication(s).\u003c/li\u003e\n \u003cli\u003eMale or female aged 18 years or more.\u003c/li\u003e\n \u003cli\u003eResident of village during the baseline survey.\u003c/li\u003e\n \u003cli\u003eHas no plans to migrate in next 12 months from the date of initiation of intervention.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003eExclusion criteria\u003c/em\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eBedridden persons who cannot provide informed consent or unable to answer the questions\u003c/li\u003e\n \u003cli\u003ePregnant or lactating mothers\u003c/li\u003e\n \u003cli\u003ePersons with a terminal medical condition or with cognitive impairment\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eWho will take informed consent? {26a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWritten informed consent will be obtained from the study participants by PI/Co-PI or health counsellor. Participants will receive a participant information sheet outlining the rationale for the study, details on interventions, the steps and protocols to be followed throughout the study, potential side effects and risks, benefits, a confidentiality statement, the option to withdraw from the study at any time, and the investigators\u0026apos; contact information.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdditional consent provisions for collection and use of participant data and biological specimens {26b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBlood samples will be collected to assess HbA1c among patients with DM and HTN after obtaining consent. These samples will be tested using point-of-care devices and will not be stored. We will request consent for review of participants\u0026rsquo; medical records, and for the collection of blood samples to assess HbA1c among the patients with type 2 diabetes. But this trial does not involve collecting biological specimens for storage.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterventions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExplanation for the choice of comparators {6b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStudies have shown that patient-tailored interventions using healthcare professionals trained in adherence, and team building with community and patients\u0026rsquo; organizations have been shown to improve medication adherence among people with, or at risk for, chronic diseases and other conditions. Peer group therapy have been used in treating psychiatric disorders, cancers, and infectious diseases like human immunodeficiency virus (HIV) and tuberculosis. The dearth of information regarding the effectiveness of peer-group therapy among diabetes and hypertensive individuals in LMICs, and high prevalence of these diseases in the Indian context, prompted us to implement this cluster-controlled multicenter study. We envisage that using community based participatory research (CBPR) methods for sustained peer group therapy could make a significant contribution to enhancing medication adherence in India in an affordable and long-lasting manner.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention description {11a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe implementation will be conducted in four phases, including the intervention of peer group therapy as shown in Figure 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePhase 1: Planning\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe process of developing the intervention started with the initial concepts based on the available literature \u0026amp; interaction with healthcare professionals working in rural areas. The objectives of the interventions included educating patients on adherence and associated challenges, providing daily management help, connecting them to clinical and community resources, and providing ongoing social and emotional support through peer group therapy.\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003e\u003cstrong\u003eDevelopment of peer group therapy sessions and education materials\u003c/strong\u003e- There will be eighteen face-to-face sessions, twice a month for the first six months and then once a month for the following six months. The agenda of these sessions are WHO adherence principles, barriers, methods for overcoming such challenges and providing daily management help. These sessions will be categorized under five modules which are: understanding disease- and medication-related information, information about disease and medication, tackling misinformation, concept of adherence, and, institutionalizing the intervention on long-term basis. Each Session will start with re-cap of the previous session and questions on adherence/NCDs followed by delivery of content for the day using teach-back technique. The last session of each module will be goal setting; and learnings. Intermediate feedback will be collected from the participants and learning from them will be incorporated in future sessions. Details of eighteen face-to-face sessions are included in Appendix-1.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eAdvocacy meetings: \u0026nbsp;\u003c/strong\u003eLine listing of villages will be done and selected villages will be stratified based on population cut-off of 2500. These villages will be randomized into intervention \u0026amp; control clusters as shown \u0026nbsp; in Figure 2.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eTo identify the eligible participants and peer educator from each cluster, a meeting will be organised with the head of the villages and the responsible NCD clinic. Under the National Programme for prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and stroke (NPCDCS)Government of India has established NCD clinics for the screening, management, counselling, andother aspects of non-communicable disease management. These clinics at community health centres level maintain individual diagnosis, treatment and referral records on the patient chronic disease card, with verbal and pictorial advice for the patient. Patients who are all eligible for the study will have their information collected from NCD clinics. Peer educators will be selected from the community. These clinics will be used for intervention implementation site.\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003e\u003cstrong\u003eSelection \u0026amp; training of team\u003c/strong\u003e: Our team will consist of principal investigator (PI), \u0026nbsp;co-principal investigators (Co-PI), health counsellor (trained psychologist/clinical pharmacologist/clinical pharmacist) and project coordinator along with a peer educator from the community. Health counsellor\u0026amp; project coordinator will be recruited and trained by the PI \u0026amp; Co-PIs. Health counsellor will deliver the intervention initially \u0026amp; project coordinator will assist the training programs and meetings, supporting health counsellor and record keeping. Peer educator will be recruited by the investigators on the advice of village head \u0026amp; NCD clinic in-charge. He should be a member of community with an interest in health care and community, willingness to learn, and leadership qualities. A strong commitment to work in the community was identified as an important criteria for the selection of all the team members.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003ePhase 2: Baseline evaluation and Implementation of intervention at coordinating site\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn the Phase 2, study will be implemented at co-ordinating site (SAMC \u0026amp; PGI, Indore) after obtaining the ethics committee approval. Written informed consent will be obtained from the study participants by PI/Co-PI or health counsellor. Participants will receive a participant information sheet (PIS) outlining the rationale for the study, details on interventions, the steps and protocols to be followed throughout the study, potential side effects and risks, benefits, a confidentiality statement, the option to withdraw from the study at any time, and the investigators\u0026apos; contact information. The baseline survey will be done at T0 visit which will include questionnaires to assess degree of adherence, health literacy and quality of life. It will be performed by trained health counsellor who have undergone training. Questions will be explained to each participant to get familiar with the contents, instructions for filling them out will be given and the responses will be recorded. Special instructions would be given not to ask or consult a colleague while answering the questionnaire. After completion of baseline survey at all clusters, intervention will be implemented in intervention clusters for 12 months. All the participants in both intervention and control arm will be permitted to used standard treatment for diabetes \u0026amp; hypertension. For the 1st 6 months, sessions will be given twice a month followed by once a month for next 6 month. Control group (wait list group) will be given intervention after the completion of 12-month session in intervention group. This will not be included for data analysis. Table 1 shows the timepoint for the intervention implementation as per SPIRIT reporting guidelines.(15)Mid-term evaluation will be done at T7 and T13 sessions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePhase 3: Interim analysis and Implementation of intervention at collaborative sites\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInterim analysis will be done after 9 months of intervention at coordinating site. If the analysis shows the expected result (8% difference in clinical outcomes between intervention and control group), study will be implemented at other collaborating site in the same pattern as coordinating site. PI and Co-PIs from collaborating site will be trained by the coordinating site team. A workshop will be conducted for this training at coordinating site.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePhase 4: Data analysis and publications\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAfter the completion of study at all the collaborating sites, data will be compiled at coordinating site. They will be analyzed and submitted to the ICMR. Results of the study will be published in peer-reviewed journal and will be shared with the participants.\u003c/p\u003e\n\u003cp\u003eAll the participants are permitted to use standard care treatment for diabetes or hypertension.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCriteria for discontinuing or modifying allocated interventions {11b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis is not applicable as the intervention is aimed to improve medication adherence, so there will no special criteria for discontinuing or modifying allocated intervention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStrategies to improve adherence to interventions {11c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe intervention is designed to enhance medication adherence in individuals with diabetes and/or hypertension, as assessed using the eight-item Morisky Medication Adherence Scale (MMAS-8). (16) Adherence to interventions will be ensured through the selection of peers from the community. Research team members (PI and Co-PI of coordinating site) will be conducting multiple visits to ensure intervention fidelity. Process evaluations will be conducted in conjunction with the intervention through interviews with treating doctors, program staff, peer educators, and target beneficiaries at regular intervals during the intervention. The analysis of these interviews will be used by program staff to improve adherence to interventions.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRelevant concomitant care permitted or prohibited during the trial {11d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConcomitant care permitted are medicines and other cares that patients\u0026apos; doctors provide to treat their hypertension and diabetes or any other associated illness.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProvisions for post-trial care {30}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis is a non-pharmacological intervention; therefore, there are no specific post-trial care provisions.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes {12}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe measure of drug adherence for hypertension and/or diabetes, as determined by the self-reported Morisky Medication Adherence Scale (MMAS-8) at baseline, midterm, and at the end, is the study\u0026apos;s outcome variable. (16) \u0026nbsp;When converted into a dichotomous variable, a score of more than 6 denotes \u0026ldquo;good adherence.\u0026rdquo; Age, gender, total number of antihypertensive and/or antidiabetic drugs used (regardless of medication class), duration using these drugs, educational attainment, marital status, occupation, monthly household income, self-perceived health status, systolic and diastolic blood pressure and/or HbA1c, and other independent variables were all controlled while doing the analysis. A standardised methodology for the detection of arterial hypertension and/or diabetes will be used to assess blood pressure and/or HbA1c.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor Indore and Himachal Pradesh sites, MMAS-8 Hindi version would be used. For the sites in Odisha and Tamil Nadu,, translation versions of MMAS-8 tool will be used using ISPOR best practices guidelines. (17) The secondary outcomes include personal health literacy improvements due to the intervention measured using All Aspects of Health Literacy Scale(AAHLS).(18)Our choice for identifying health literacy as a secondary outcome is based on the conceptual causal model linking health literacy to health outcomes as documented in Paasche-Orlow\u0026amp; Wolf (2007) (Annexure I). (19) Other secondary outcomes include improvement in clinical outcomes measured in terms of HbA1c and blood pressure in patients with diabetes and/or hypertension in both the groups. HbA1c and blood pressure will be measured at baseline and will be compared from midline and endline measurements. Improvements in medication adherence is expected to improve quality of life among persons with diabetes and/or hypertension and this will be assessed using a validated version of the EURO Quality of life-5D (EQ-5D) in the local language of the target sub-districts. (20) User satisfaction with the intervention will be assessed using a validated version in the local language of the Patient Satisfaction Questionnaire Short-Form (PSQ-18). (21) Additional outcomes will include costs of intervention, cost-consequence based on the observed results within the trial period, and (2) cost-effectiveness analysis where differences between groups in the trial will be extrapolated to the longer term where appropriate. Fidelity of intervention will be monitored using the Normalisation Process Theory framework.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipant timeline {13}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTable 1: Timepoint for the intervention implementation\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size {14}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe required sample size will be determined by focusing on the primary objective of this trial, which was to evaluate the effect of peer group therapy on medical adherence in diabetics and hypertensives in rural India. Sample size was calculated using the parameters of the study published by Amir et al (2021) and Abdullah et al (2022) on hypertensive and diabetes medication adherence population, respectively. (22,23) R software version 4.1.3 was used for the sample size calculation. Proportion of hypertension and Type-II diabetes medication adherence among 18 years and above was 57.3% and 53.4%, respectively in the control group. (24) Sample sizes of 1088 in control group and 1088 in intervention group, which were obtained by sampling 32 (𝑚) clusters with 34 subjects each in control group and 32 clusters with 34 subjects each in intervention group, achieve 90% power (𝛽) and 5% (𝛼) (one sided) significance level, allowing for intra-cluster correlation (ICC) 0.02 (𝜌) to detect a difference between the intervention and control group proportions of 8% [pI = 61.4%] through the formula: (22,23,24)\u003c/p\u003e\n\u003cp\u003e\u003cimg 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\" width=\"659\" height=\"119\"\u003e\u003c/p\u003e\n\u003cp\u003eConsidering the 20% loss to follow up, we anticipated the final sample size of ~2880 from 4 participating centers, i.e., 360 per group and per center to complete sample size.\u003c/p\u003e\n\u003cp\u003e\u0026bull; Total number of clusters in Control group= 32 [Village [4]X Population Group [2]X Centre [4]] = Total number of clusters Intervention group\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026bull; Total participants per cluster in Control group per center= 360 [ i.e., 45 from each of Village [8]] = Total participants per cluster in Intervention group\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026bull; Total participants= 2880 [720 X 4 Centers]\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment {15}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe village on the list will be visited by our team. Principal Investigator (PI) and Co-Principal Investigator (Co-PI) in charge of implementation will meet the heads of the village and the NCD clinic. Patients who are all eligible for the study will have their information collected. We will only enroll patients who agree to participate in the trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssignment of interventions: allocation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSequence generation {16a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAllocation of intervention and sequence generation will be conducted as follows. Codes will be randomly assigned to the two interventions (CBPR and control groups) namely A and B. In the next step, randomization list will be generated using RANDOM ALLOC software. 4 centers will be randomized into 2 study groups (A and B). Each center will be allocated random numbers ranging from 1 to 4 using computer random number generators. Following randomization, participants and caregivers will be aware of whether they are in an intervention village or control village. Participants who fulfil the eligibility criteria and signed the informed consent will be included in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConcealment mechanism {16b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDue to the nature of the intervention (peer-group) blinding is not possible for this trial. However, study site allocation will be done only after completing baseline assessment and agreements with sites to participate. A centralised online computer-generated system (Sealed Envelope) will conceal allocation for the study. The allocation sequence is provided to the PI/Co-PI at each site via this secure system. Once participants are randomised to a treatment arm, PI/Co-PI in charge of implementation will meet the heads of the village and the NCD clinic. Patients who are all eligible for the study will have their information collected and those patients who agree to participate in the trial will be included. The system has restricted access of the allocation, which is only assigned to specific personnel, i.e.unblind statistician.All other study personnel involved in direct study conduct and participants are completely blinded to the randomisation system. It will not be possible for the study team to determine treatment allocation using laboratory data during the trial period.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation {16c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA statistician who will be unaware of the group assignment will assign randomly selected villages to each stratum using computer generated random number, and also assign random treatment allocation. The enrolment will be by done by the Co-PI and the Co-PI will assign village as it is a cluster randomized trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssignment of interventions: Blinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho will be blinded {17a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData analysts (biostatisticians) will be blinded. The patients, their caregivers and outcome assessors are not blinded.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cbr\u003e\u0026nbsp;Procedure for unblinding if needed {17b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this study, the patients, their caregivers and outcome assessors will not be blinded. Only the data analyst will be blinded. The data analyst will be unblinded if there are any outlier biochemical values which requires immediate action so that the patient can be intimated.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection and management\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for assessment and collection of outcomes {18a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary outcome is the improvement in medication adherence in diabetes and/or hypertension as measured using the eight-item Morisky Medication Adherence Scale (MMAS-8). (16) The MMAS-8 consists of eight questions, first seven items having a dichotomous answer (yes/no) that indicates adherence or non-adherent behaviour. For item 8, a patient can choose an answer on a 5-point Likert scale, expressing how often happens that a patient does not take his medications. MMAS-8 scores can range from 0 to 8 points. Cut-off values for categorizing patients as having a high, medium or low adherence rates are chosen. For Indore site, MMAS-8 Hindi version would be used. For the sites in Odisha and Tamil Nadu, translation versions of MMAS-8 tool will be used using ISPOR best practices guidelines. (17)\u003c/p\u003e\n\u003cp\u003eWe will be using CDC\u0026rsquo;s definition of personal health literacy, which is the degree to which individuals can find, understand, and use information and services to inform health-related decisions and actions for themselves and others. (25) Personal health literacy improvements due to the intervention will be measured using All Aspects of Health Literacy Scale(AAHLS). (18) It measures patients\u0026apos; functional, communicative, and critical health literacy in the context of basic healthcare. There are thirteen items in all, and item number 1 to 10 are rated on a 3-point Likert scale with the prompts \u0026quot;rarely\u0026quot;, \u0026quot;sometimes\u0026quot;, and \u0026quot;often\u0026quot; . Whereas item number 11\u0026ndash;13 are analyzed on a 2-point Likert scale in a descriptive manner. Higher total scores indicate a higher level of health literacy.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eImprovement in clinical outcomes will be measured in terms of HbA1c and blood pressure in patients with diabetes and/or hypertension in both the groups. HbA1c and blood pressure will be measured at baseline and will be compared from midline and endline measurements. For HbA1c measurement, 5 ml of blood will be collected from participants by venipuncture after taking consent in EDTA tube. Samples will be carried to analysis center in icepack (2-8 degree Celsius) andwill be analyzed in Trivitron nano H5 machine using High Performance Liquid Chromatography (HPLC) technique. Calibration of the instrument will be as per manufacturer\u0026rsquo;s guidelines and lab quality assurance. Blood pressure measurement will be done using digital sphygmomanometer and will be measured as per Centers for Disease Control and Prevention (CDC) guideline. Calibration of the instrument will be as per manufacturer\u0026rsquo;s guidelines.\u003c/p\u003e\n\u003cp\u003eImprovement in quality of life among persons with diabetes and/or hypertension will be assessed using a validated version of the EURO Quality of life-5D (EQ-5D) in the local language of the target sub-districts. The EQ-5D\u0026rsquo;s descriptive system is a preference-based Health Related Quality of Life (HRQoL) measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression measured at 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A lower score indicates a better quality of life. (20)\u003c/p\u003e\n\u003cp\u003eUser satisfaction with the intervention will be assessed using a validated version in the local language of the Patient Satisfaction Questionnaire Short-Form (PSQ-18). (21) The PSQ-18 contains 18 times tapping each of the seven dimensions of satisfaction with medical care measured by the PSQ-III: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Subjects have five options when answering each question: Strongly agree, Agree, Uncertain, Disagree and Strongly Disagree, with 1-5 points for each answer, where 5 mean the highest satisfaction. (21)\u003c/p\u003e\n\u003cp\u003eFor cost-consequence and cost-effectiveness analyses, costs in both arms will be estimated from a societal perspective. Costs will be accounted under two categories: 1. Total cost of the intervention, and 2. Treatment cost of diabetes and/or hypertension. Treatment costs will be categorized as direct medical costs, direct non-medical costs, and indirect costs. Direct medical costs will include out-of-pocket expenses incurred to seek treatment (e.g. diagnostic tests, fees for consultation in clinics, traditional healers, hospitals, bed day charges at a public or private health facility). Direct non-medical costs will include the amount spent for traveling to the health facility for the patient and accompanied persons for treatment, the amount spent on meals/food taken while waiting for treatment, expenses for overnight accommodation for seeking care, etc. Indirect costs represent the opportunity cost for the patient and their household members\u0026rsquo; time related to diabetes and/or hypertension. Cost data will be collected at baseline and each month from all study participants. Time spent by the peer educators will be obtained from the program implementation data. The minimum wage rate of the state will be used to value their time. Total hours spent on the program will be multiplied by hourly wage (obtained from the minimum wage rate) to get the time cost of the peer educators. Benefits will be considered based on improved health, functioning, participation, productivity, increased saving and investment, reduced informal caregiving, and health and welfare services. Lost workdays before and after the intervention will be obtained through the WHO-DAS 12 questionnaire and will be linked to the minimum wage rate to estimate the aggregate effect. (26)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eProcess evaluation will be conducted using a mix of questionnaires, interviews, and focus groups. The process evaluation will be used to understand: The participants\u0026rsquo; experiences of the intervention and its different components; any discrepancies between expected and observed outcomes; the influence of intervention components and context of the observed outcomes; sustainability; the extent of any contamination between intervention and control; and any unexpected events arising from participation. Self-reported questionnaires will be provided to study participants to evaluate their opinions of the various intervention components. Interviews and focus groups with study participants (sub-sample) will further examine engagement in the various components of the intervention, along with any barriers or facilitators to participating in the various components. Focus groups with study participants (sub-sample) will further examine the intervention implementation and participants\u0026rsquo; experiences of delivery. All interviews and focus groups will be audio-recorded and transcribed verbatim.\u003c/p\u003e\n\u003cp\u003eThroughout the intervention, the fidelity of the intervention implementation will be monitored using the Normalisation Process Theory Framework.(27) Observations will take place in intervention arms across clusters to assess whether the intervention was delivered as expected and receipt of the intervention by the attendees. During the observations, a case report form will also be completed. The case report form will combine an \u0026lsquo;adherence measure\u0026rsquo; to capture delivery (mode of delivery (dose/duration/content) and use of resources (materials/activities).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans to promote participant retention and complete follow-up {18b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll efforts will be made to retain all participants in the study. Due to the institutions providing medical and clinical care in the respective study sites, there is a good rapport with the study group, local self-government, and frontline health workers. Loss to follow-up may result from migration to their children\u0026rsquo;s places of living or death or for other reasons. The characteristics of the patients who drop out will be recorded and compared to those who are in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData management {19}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll the PIs and Co-PIs along with data entry operators will have access to the research data. \u0026nbsp;All the qualitative and quantitative data will be stored in paper format as well as electronically. The paper copies and documents will be kept in closed cabinets at the individual sites under lock and key and will have limited access to the data management team. \u0026nbsp;The electronic data will be stored on cloud using a separate google drive account for the purpose of this research with access restricted to the data management team only. Audit trails ofongoing decisions including revision of existing codes and emergent codes will be kept for all interviews. Quality of data will be ensured at every step by the site data operators, PIs and Co-PIs. Strict confidentiality will be maintained while handling the data. The data will be stored for a period of 5 years. The results generated out of this research will be freely shared with public and research community through research publications.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConfidentiality {27}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConfidentiality of the participants will be ensured during recruitment of the participants, data collection, during transcription, data analysis and during dissemination of research results. It will be done by assigning unique ID to the participants while recruitment and coding them during analysis. This will be stored confidentially before, during, and after the trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe baseline survey will include questionnaires to assess degree of adherence, health literacy and quality of life. It will be performed by trained health counsellor who have undergone training. Questions will be explained to each participant to get familiar with the contents, instructions for filling them out will be given and the responses will be recorded. Special instructions would be given not to ask or consult a colleague while answering the questionnaire. For HbA1c measurement, 5 ml of blood will be collected from participants by venipuncture after taking consent in EDTA tube. Samples will be carried to analysis center in icepack (2-8 degree Celsius) and will be analyzed in Trivitron nano H5 machine using High Performance Liquid Chromatography (HPLC) technique. Calibration of the instrument will be as per manufacturer\u0026rsquo;s guidelines and lab quality assurance. Blood pressure measurement will be done using digital sphygmomanometer and will be measured as per Centers for Disease Control and Prevention (CDC) guideline. Calibration of the instrument will be as per manufacturer\u0026rsquo;s guidelines. This trial does not involve collecting biological specimens for storage. In this study, blood samples will be collected to assess random blood sugar and HbA1c. These tests are done using point-of-care devices. The blood samples will not be stored in the current trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods for primary and secondary outcomes {20a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData will be collected by following the well-structured questionnaire and entered in SPSS. Data will be analyzed using software STATA or SPSS. The intention-to-treat principle will form the basis of the primary analysis. For all patient\u0026ndash;related outcome analyses, we will conduct cluster\u0026ndash;specific methods. Dichotomous outcomes will be compared between intervention and control group using a chi-square test. Continuous outcomes will be compared between intervention and control using t-test or non-parametric test, and for more than two groups\u0026rsquo; comparison ANOVA test/ Krushkal test, and post hoc test for within group\u0026rsquo;s comparison after more than 2 follow up repeated measures ANOVA test/ Friedman test will be applied. Pre and post interventional comparison will be done using paired t-test / Wilcoxon sign rank test.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMultilevel modeling (linear or logistic as appropriate) will be used to compare the primary outcome pre-intervention to post-intervention data between groups while adjusting for potential convariates (age, sex, and co- morbidities or secondary outcomes (blood pressure, random blood sugar, Hba1c levels and quality of life.\u003c/p\u003e\n\u003cp\u003eWhen the MMAS-8 score is dichotomized (e.g., high adherence vs. low adherence, a multilevel logistic regression model will be used to compare adherence between groups while accounting for clustering within the data. (28,29,30) The Model includes (31):\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cul type=\"circle\"\u003e\n \u003cli\u003e\u003cstrong\u003eLevel 1 (individual level):\u003c/strong\u003e This includes patient-level factors such as age, gender, socioeconomic status, or duration of illness.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eLevel 2 (cluster level):\u003c/strong\u003e This includes higher-level factors such as clinics or regions, if the patients are nested within these settings.\u003c/li\u003e\n \u003c/ul\u003e\n\u003c/ul\u003e\n\u003cp\u003eWhen the MMAS-8 score is treated as a continuous variable (ranging from 0 to 8), a multilevel linear regression model is appropriate for analyzing adherence.(27, 32) \u0026nbsp;The model includes:\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cul type=\"circle\"\u003e\n \u003cli\u003e\u003cstrong\u003eLevel 1 (individual level):\u003c/strong\u003e Continuous MMAS-8 scores are modeled at the patient level with covariates such as age, income, or comorbidities.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eLevel 2 (cluster level):\u003c/strong\u003e Clinics, doctors, or geographic regions where patients are nested are treated as higher-level units, introducing random intercepts (or slopes, if needed).\u003c/li\u003e\n \u003c/ul\u003e\n\u003c/ul\u003e\n\u003cp\u003eBy using \u003cstrong\u003emultilevel modeling\u003c/strong\u003e, we can effectively compare adherence outcomes while accounting for the hierarchical structure of the data (e.g., patients nested within clinics), making the estimates more reliable and appropriately controlling for between-group variability. Additionally, a return on investment (ROI) analysis, expressing benefits in monetary terms relative to investments made, and expressing both the costs and the full range of benefits of an intervention in the same units (money), will also be conducted. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWithin the period of the trial, we will collect resource use estimates from participant questionnaires. These questionnaires will record health resources that the population is likely\u003c/p\u003e\n\u003cp\u003eto use services such as outpatient and any other health services (e.g. laboratory). The within-trial analysis will present incremental results for the primary and secondary outcomes using EQ-5D in both arms and will be compared with the incremental costs measured. While there may be short-term benefits to improving adherence, the longer-term effect on mortality will likely be more important. We will use existing evidence that links short-term trial endpoints and longer-term outcomes. While some existing evidence used covariates to adjust for confounding factors, it is not possible to assess unmeasured confounders. We will use existing evidence to extrapolate costs and effects to a more appropriate time horizon as recommended by Taylor and Elston (2009) and to explain how the relationship of surrogate-final outcomes quantified and explore the uncertainty around the use of the surrogate outcome (i.e., adherence) through sensitivity analysis. (33)\u003c/p\u003e\n\u003cp\u003eIf appropriate an Incremental Cost-Effectiveness Ratio (ICER) for the extrapolated period will be reported using the Quality Adjusted Life Year (QALY). Costs and effects will be discounted at 3% as per WHO guidelines but will be the subject of sensitivity analysis to reflect the ongoing uncertainty around appropriate discount rates for public health interventions. Probabilistic sensitivity analysis will be conducted to allow characterization of the uncertainty around the adoption decision which will be depicted using cost-effectiveness acceptability curves. Sensitivity analysis will be performed to determine the robustness of the results to altering certain assumptions such as discount rate, intervention costs, and the robustness of the relationship between adherence and mortality. Being alive and healthy will also be considered valuable and the overall value of a life year will be broken down into its economic (instrumental) and health (intrinsic) elements. Following the approach used in prior ROI analyses in diabetes and/or hypertension, a figure of 0.5 times the per-capita income of India will be considered as the value of a healthy life year. (34) \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eQualitative interviews will be recorded and analysed thematically, using both inductive and deductive coding approaches. Two coders will independently code each transcript by identifying emergent themes and interview guides. Broader themes will be broken down into smaller, more specific subthemes until no further subcategories are required. Inter-coder reliability will be assessed; agreement between 66 and 97% will considered as good reliability. Any coding disagreements will be resolved through project team discussions and where required, a third independent coder will re-code the transcript. Questionnaire data will be summarized using frequency counts and means (+/- SD) where appropriate. Audio-recordings of interviews and focus groups will be transcribed verbatim and analysed using framework analysis using the Normalisation Process Theory as the overarching framework. (27)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterim analyses {21b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInterim analysis will be done at 9\u003csup\u003eth\u003c/sup\u003e month of intervention at the coordinating site. Since the risk due to the intervention (CBPR method) is minimal or none, interim analysis, and stopping guidelines have not been prescribed by the ethical committee and therefore will not be any stopping guidelines.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods for additional analyses (e.g. subgroup analyses) {20b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSubgroup analysis will not be carried out. However, for the primary and secondary outcome variables, covariates such as age, sex, and co-morbidities will be considered as potential confounders in the mixed effect model analysis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNonadherence will be managed by the intention to treat analysis and if there are too many missing data, imputations using Markov Chain Monte Carlo (MCMC) for missing data problems arising due to the longitudinal nature of the study will be considered. Mixed method analysis will be considered for intention to treat analysis. Also depending on the percentage of data missingness and assumption for data missing in the study variables, appropriate missing data imputation technique will be used.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans to give access to the full protocol, participant level-data and statistical code {31c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFull protocol can be given. Full dataset can be given with the permission of the participating institutions, and ICMR.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOversight and monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eComposition of the coordinating centre and trial steering committee {5d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePrincipal Investigators and Co-PIs will form a project management unit (PMU) andwill meet every month online to discuss the progress of the project and the PI will report quarterly to the oversight steering committee. Recruitment, follow-up rates, and missing data will be discussed at monthly review meetings between data manager and field data collectors. The oversight steering committee will be consisting of senior members from various institutions including Dean or heads of collaborating institutions, who are not directly involved with the project. Their objective is to ensure that the PI gets the strategic support for all the activities of the research project.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eComposition of the data monitoring committee, its role and reporting structure {21a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe PI will be conducting all aspects of data collection and management. All participants will be given a unique study Participation Identification Number (PIN). Data will be entered under this identification number onto the laptop of the PI that will be controlled with a unique username and password. Once data entry is complete, the database will be locked prior to any trial analysis. Following consent, identifiable (consented participants only) data linked to the PIN will be held locally at the research office in a locked filing cabinet. After completion of the study, the identification, screening and enrolment logs will be securely archived at the research office for 5 years, unless otherwise advised by the university.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdverse event reporting and harms {22}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs this study is measuring adherence of an intervention, no adverse events or serious adverse events and harms from the intervention are anticipated. We will consider adverse events as stopping treatment altogether, or any adverse events arising due to the medications. A protocol for reporting and recording of adverse events is provided in the Additional file. All team members will be trained by the data manager and PI on proper identification, recording, and reporting of adverse events. All adverse events will be tracked as per protocol and reported to the Institutional Ethics Committee within 15 days of occurrence, District Health Authority and Trial Steering Committee. Trial deviations will be reported to the ethical committee. Harms reporting in the final publication will be conducted as per CONSORT Harms 2022 statement. (35)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFrequency and plans for auditing trial conduct {23}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe meetings of the Project management group, Trial Steering group, independent data monitoring, and Ethics Committee periodically will also serve to audit the trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBefore the start and at the start, there have been some minor modifications which has been updated to the ethical committee and subsequently uploaded in the CTRI.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination plans {31a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe results of the study will be published in standard peer-review journals with authorship as per ICMJE (2023) and CRediT recommendations. Social media and Stakeholder workshops will be used to disseminate the findings. A plain-language summary will be shared with all participants.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis cluster-randomized, multi-centric trial will be one of the unique studies which will be benefitting the community by increasing the drug adherence for chronic conditions using CBPR model. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe trial will be using type 2 hybrid effectiveness-implementation design, with the effectiveness study conducted in the West zone of the country and the implementation to be replicated in other 3 zones of India, in the areas with diverse culture and beliefs, which will make the model more generalizable, and will make the evidence applicable for India and South Asia, and similar contexts. A hybrid type 2 design has a dual focus on the clinical intervention and implementation related factors. In hybrid type 2 designs, it is important to have an explicitly described implementation strategy that is thought to be plausible in the real world. Hybrid type 2 designs always need explicit measurement of implementation outcome (e.g., adoption, fidelity) and it is important to be clear about the intervention components versus the implementation strategy components. (36,37) Stepped wedge designs involves implementing an intervention over time in a staggered way usually involving cluster randomization, with collection of observations during a baseline period, and then randomly assigning clusters to receive the intervention at regular intervals. (38)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThere are significant expected implementation challenges to note. First, the trial involves working with the primary clinics providing NCD screening and detection services, and building an effective partnership with the state government of each state where the project will be implemented will be crucial for its success. Second, medication nonadherence for patients with chronic diseases is extremely common with 40%-50% of patients prescribed medications for management of diabetes and hypertension. (39) There exist treatment-related barriers, such as treatment complexity, side effects (or fear of side effects), inconvenience, cost, and time, and other barriers such as poor practitioner-patient relationship, aspects of which are beyond the scope of the intervention. (40,41)\u003c/p\u003e\n\u003cp\u003eIf successful, the medication adherence intervention, using minimum technology and low financial investment has the potential to constitute evidence-based practice for improving medication adherence for diabetes and hypertension in India, and in similar developing countries. The use of CBPR has the potential to improve health literacy among the target populations thus making the study sustainable beyond the project period. The examination of implementation processes throughout the trial will also help in preparing a roadmap for policymakers and researchers to implement and scale-up implement medication adherence interventions in diabetes and hypertension and potentially other non-communicable diseases in other settings.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial status\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe current protocol is version 6.0 dated 28/02/2024. The recruitment began on March 01, 2024 and is expected to be complete by July 01, 2025. The submission has been delayed due to unavoidable circumstances such as changes in trial registry and weather.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCBPR: Community based participatory research\u003c/p\u003e\n\u003cp\u003eWHO: World health organization\u003c/p\u003e\n\u003cp\u003eMMAS 8: \u0026nbsp;Morisky Medication Adherence Scale 8\u003c/p\u003e\n\u003cp\u003eAAHLS: All Aspects of Health Literacy Scale\u003c/p\u003e\n\u003cp\u003eICMR: Indian Council of Medical Research\u003c/p\u003e\n\u003cp\u003eNCD: Non-communicable diseases\u003c/p\u003e\n\u003cp\u003eHIV: Human immunodeficiency virus\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMRHRU: Model rural health research unit\u003c/p\u003e\n\u003cp\u003ePI: Principal investigator\u003c/p\u003e\n\u003cp\u003eCo-PI: Co principal investigators\u003c/p\u003e\n\u003cp\u003eICER: IncrementalCost-Effectiveness Ratio\u003c/p\u003e\n\u003cp\u003eCDC:\u0026nbsp;Centers for Disease Control and Prevention\u003c/p\u003e\n\u003cp\u003eHPLC: High Performance Liquid Chromatography\u003c/p\u003e\n\u003cp\u003eQALY: Quality Adjusted Life Year\u003c/p\u003e\n\u003cp\u003eNP-NCD: National Programme for Non-Communicable Diseases\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch3\u003eAcknowledgements\u003c/h3\u003e\n\u003cp\u003eThe authors acknowledge ICMR and Sri Aurobindo Medical College \u0026amp; PGI, Indore for all the support provided for this research.\u003c/p\u003e\n\u003ch3\u003eAuthors\u0026rsquo; contributions\u003c/h3\u003e\n\u003cp\u003ePR is the Chief Investigator; conceived the study, led the proposal and protocol development and acquired funding, Methodology, Writing-Original Draft Preparation, Review \u0026amp; Editing\u003c/p\u003e\n\u003cp\u003eAJ- Design of intervention, development of the proposal, acquired funding, Methodology, Writing-Original Draft Preparation, Review \u0026amp; Editing\u003c/p\u003e\n\u003cp\u003eHG \u0026amp; VV are involved as statisticians and will conduct the statistical and qualitative analyses. Writing- Review \u0026amp; Editing\u003c/p\u003e\n\u003cp\u003eDK, AB, SM, TR, SKR, MJ, ACPR, SK, KS and BU will be responsible for implementing intervention at collaborating sites. Writing- Review \u0026amp; Editing\u003c/p\u003e\n\u003cp\u003eJC \u0026amp; TA are attached to ICMR and are research managers to the project, Writing- Review \u0026amp; Editing\u003c/p\u003e\n\u003cp\u003eDJ is lead trial methodologist and for economic evaluation, Writing \u0026ndash; Original Draft Preparation, Review \u0026amp; Editing\u003c/p\u003e\n\u003cp\u003eAll authors read and approved the final manuscript.\u003c/p\u003e\n\u003ch3\u003eFunding\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThis is a ICMR funded research protocol under National task force on Safe and Rational Use of Medicine. Protocol ID is 2023-20019, version 6 dated 28/02/2024. JC \u0026amp; TA is employed with ICMR who have funded the study. JC \u0026amp; TA have contributed to protocol development, and agreement to the final manuscript. The funding institution had no other role in the development of this protocol.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eContact\u003c/h3\u003e\n\u003cp\u003eDr. Jerin Cherian,\u0026nbsp;Medical Scientist, Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, New Delhi, Email: [email protected]\u003c/p\u003e\n\u003ch3\u003eAvailability of data and materials\u003c/h3\u003e\n\u003cp\u003eThe investigators will have access to the final data set. There are no contractual agreements which limit access to investigators. The investigators in the field collect the data and data will be entered in RedCap software. Any data required to support the protocol can be supplied on request.\u003c/p\u003e\n\u003ch3\u003eEthics approval and consent to participate\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eEthics committee approval has been obtained from the Institutional Ethics Committee of Sri Aurobindo Medical College \u0026amp; PGI, Indore for protocol version 6 dated 28/02/2024. Written, informed consent to participate will be obtained from all participants.\u003c/p\u003e\n\u003ch3\u003eConsent for publication\u003c/h3\u003e\n\u003cp\u003eInformed consent has been obtained and the model consent form can be made available. No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results.\u003c/p\u003e\n\u003ch3\u003eCompeting interests\u003c/h3\u003e\n\u003cp\u003eThe authors declare that there are no competing interests\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eMinistry of Health and Family Welfare. https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1796435#:~:text=The%20four%20major%20NCDs%20are,use%20of%20tobacco%20and%20alcohol. \u0026nbsp; Accessed 17 June 2023\u003c/li\u003e\n \u003cli\u003eBurden of NCDs and their risk factors in India. http://www.searo.who.int/india/topics/noncommunicable_diseases/ncd_situation_global_report_ncds_2014.pdf. Accessed 17 June 2023\u003c/li\u003e\n \u003cli\u003ePolonsky WH, Henry RR. Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors. Patient preference and adherence. 2016 Jul 22:1299-307.\u003c/li\u003e\n \u003cli\u003eWorld Health Organization.\u0026nbsp;(\u0026lrm;2003)\u0026lrm;.\u0026nbsp;Adherence to long-term therapies : evidence for action.\u0026nbsp;World Health Organization.\u003c/li\u003e\n \u003cli\u003eBrown MT, Bussell JK. Medication adherence: WHO cares?.InMayo clinic proceedings 2011 Apr 1 (Vol. 86, No. 4, pp. 304-314)\u003c/li\u003e\n \u003cli\u003eHaynes RB. Interventions for helping patients to follow prescriptions for medications. Cochrane Database of Systematic Reviews, 2001, Issue 1.\u003c/li\u003e\n \u003cli\u003eFisher EB, Ballesteros J, Bhushan N, Coufal MM, Kowitt SD, McDonough AM, Parada H, Robinette JB, Sokol RL, Tang PY, Urlaub D. Key features of peer support in chronic disease prevention and management. Health affairs. 2015 Sep 1;34(9):1523-30.\u003c/li\u003e\n \u003cli\u003eDavidson L, Chinman M, Sells D, Rowe M. Peer support among adults with serious mental illness: a report from the field. Schizophrenia bulletin. 2006 Jul 1;32(3):443-50..\u003c/li\u003e\n \u003cli\u003eHu J, Wang X, Guo S, Chen F, Wu YY, Ji FJ, Fang X. Peer support interventions for breast cancer patients: a systematic review. Breast Cancer Research and Treatment. 2019 Apr 15;174:325-41.\u003c/li\u003e\n \u003cli\u003eEkstrand ML, Heylen E, Pereira M, D\u0026rsquo;Souza J, Nair S, Mazur A, Shamsundar R, Kumar BR, Chandy S. A behavioral adherence intervention improves rates of viral suppression among adherence-challenged people living with HIV in South India. AIDS and Behavior. 2020 Jul;24:2195-205..\u003c/li\u003e\n \u003cli\u003eMagidson JF, Joska JA, Belus JM, Andersen LS, Regenauer KS, Rose AL, Myers B, Majokweni S, O\u0026rsquo;Cleirigh C, Safren SA. Project Khanya: results from a pilot randomized type 1 hybrid effectiveness‐implementation trial of a peer‐delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa. Journal of the International AIDS Society. 2021 Jun;24:e25720.\u003c/li\u003e\n \u003cli\u003eBarik AL, Indarwati R. The role of social support on treatment adherence in TB patients: a systematic review. Nurse and health: Jurnalkeperawatan. 2020;9(2):201-10.\u003c/li\u003e\n \u003cli\u003eBalagopal P, Kamalamma N, Patel TG, Misra R. A community-based participatory diabetes prevention and management intervention in rural India using community health workers. The Diabetes educator. 2012 Nov;38(6):822-34.\u003c/li\u003e\n \u003cli\u003eYau JH, Lok E, Wong Y, Kanagawa HS, Wong NH, Liu T, Wong GH, Lum T. Using community-based participatory research to promote mental health literacy in older Chinese. Innovation in Aging. 2022 Nov;6(Supplement_1):735-735.\u003c/li\u003e\n \u003cli\u003eChan A-W, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hr\u0026oacute;bjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586\u003c/li\u003e\n \u003cli\u003eMorisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting.\u0026nbsp;J Clin Hyperten.\u0026nbsp;2008;10:348\u0026ndash;54\u003c/li\u003e\n \u003cli\u003eWild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104\u003c/li\u003e\n \u003cli\u003eChinn D, McCarthy C. All Aspects of Health Literacy Scale (AAHLS): developing a tool to measure functional, communicative and critical health literacy in primary healthcare settings. Patient education and counseling. 2013 Feb 1;90(2):247-53.\u003c/li\u003e\n \u003cli\u003ePaasche-Orlow MK, Wolf MS. The causal pathways linking health literacy to health outcomes. Am J Health Behav. 2007 Sep-Oct;31 Suppl 1:S19-26\u003c/li\u003e\n \u003cli\u003eHerdman M, Gudex C, Lloyd A, Janssen MF, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727\u0026ndash;36.\u003c/li\u003e\n \u003cli\u003eMarshall\u0026nbsp;GN\u0026nbsp;,\u0026nbsp;Hays\u0026nbsp;RD\u0026nbsp;.\u0026nbsp;The Patient Satisfaction Questionnaire Short Form (PSQ-18).\u0026nbsp;1994;\u0026nbsp;Santa Monica, CA:\u0026nbsp;RAND Corporation.\u0026nbsp;7865\u003c/li\u003e\n \u003cli\u003eAmer M, Ur Rehman N, Nazir SUR, Ehsan-Ul-Haq M, Sultana M, Jabeen M. Devoid Knowledge and Low Adherence Precipitate Uncontrolled Blood Pressure: A Depiction From Cross-Sectional Study. Altern Ther Health Med. 2021 Sep;27(5):24-32\u003c/li\u003e\n \u003cli\u003eAbdullah NF, Khuan L, Theng CA, Sowtali SN. Prevalence and reasons influenced medication non-adherence among diabetes patients: A mixed-method study. Journal of Diabetes \u0026amp; Metabolic Disorders. 2022 Dec;21(2):1669-78.\u003c/li\u003e\n \u003cli\u003eSuseela RP, Ambika RB, Mohandas S, Menon JC, Numpelil M, Vasudevan BK, Ved R, Danaei G, Spiegelman D. Effectiveness of a community-based education and peer support led by women\u0026rsquo;s self-help groups in improving the control of hypertension in urban slums of Kerala, India: a cluster randomised controlled pragmatic trial. BMJ Global Health. 2022 Nov 1;7(11):e010296\u003c/li\u003e\n \u003cli\u003eCenters for Disease Control. What is Health Literacy? https://www.cdc.gov/healthliteracy/learn/index.html#:~:text=Personal%20health%20literacy%20is%20the,actions%20for%20themselves%20and%20others. Accessed on 19 June 2023\u003c/li\u003e\n \u003cli\u003eWorld Health Organisation. Measuring Health and Disability: Manual for WHO Disability Assessment Schedule (WHODAS 2.0). 2010. Retrieved fromhttp://apps.who.int/iris/bitstream/10665/43974/1/9789241547598_eng.pdf. Accessed on 30 June 2024\u003c/li\u003e\n \u003cli\u003eMurray, E., Treweek, S., Pope, C. et al. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010; 8, 63\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eLee, G. K., Wang, H. H., Liu, K. Q., Cheung, Y., Morisky, D. E., \u0026amp; Wong, M. C. (2013). Determinants of medication adherence to antihypertensive medications among a Chinese population using Morisky Medication Adherence Scale. PloS one, 8(4), e62775.\u003c/li\u003e\n \u003cli\u003eAlalaqi, A., Lawson, G., Obaid, Y., \u0026amp; Tanna, S. (2021). Adherence to cardiovascular pharmacotherapy by patients in Iraq: A mixed methods assessment using quantitative dried blood spot analysis and the 8-item Morisky Medication Adherence Scale. Plos one, 16(5), e0251115.\u003c/li\u003e\n \u003cli\u003eIslam, S. M. S., Islam, M. T., Uddin, R., Tansi, T., Talukder, S., Sarker, F., ... \u0026amp; Rawal, L. B. (2021). Factors associated with low medication adherence in patients with Type 2 diabetes mellitus attending a tertiary hospital in Bangladesh. Lifestyle Medicine, 2(4), e47.\u003c/li\u003e\n \u003cli\u003eJafar, T. H., Gandhi, M., De Silva, H. A., Jehan, I., Naheed, A., Finkelstein, E. A., ... \u0026amp; Feng, L. (2020). A community-based intervention for managing hypertension in rural South Asia. New England Journal of Medicine, 382(8), 717-726.\u003c/li\u003e\n \u003cli\u003eOkello, S., Nasasira, B., Muiru, A. N. W., \u0026amp; Muyingo, A. (2016). Validity and reliability of a self-reported measure of antihypertensive medication adherence in Uganda. PloS one, 11(7), e0158499.\u003c/li\u003e\n \u003cli\u003eTaylor RS, Elston J. The use of surrogate outcomes in model-based cost-effectiveness analyses: a survey of UK Health Technology Assessment reports. Health Technol Assess. 2009 Jan;13(8):iii, ix-xi, 1-50\u003c/li\u003e\n \u003cli\u003eStenberg K, Axelson H, Sheehan P, Anderson I, G\u0026uuml;lmezoglu AM, Temmerman M, Mason E, Friedman HS, Bhutta ZA, Lawn JE, Sweeny K, Tulloch J, Hansen P, Chopra M, Gupta A, Vogel JP, Ostergren M, Rasmussen B, Levin C, Boyle C, Kuruvilla S, Koblinsky M, Walker N, de Francisco A, Novcic N, Presern C, Jamison D, Bustreo F; Study Group for the Global Investment Framework for Women\u0026apos;s Children\u0026apos;s Health. Advancing social and economic development by investing in women\u0026apos;s and children\u0026apos;s health: a new Global Investment Framework. Lancet. 2014 Apr 12;383(9925):1333-135\u003c/li\u003e\n \u003cli\u003eJunqueira DR, Zorzela L, Golder S, Loke Y, Gagnier JJ, Julious SA, Li T, Mayo-Wilson E, Pham B, Phillips R, Santaguida P, Scherer RW, G\u0026oslash;tzsche PC, Moher D, Ioannidis JPA, Vohra S; CONSORT Harms Group. CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials. BMJ. 2023 Apr 24;381:e073725\u003c/li\u003e\n \u003cli\u003eLandes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res. 2019 Oct;280:112513\u003c/li\u003e\n \u003cli\u003eCurran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26\u003c/li\u003e\n \u003cli\u003eLi F, Wang R. Stepped Wedge Cluster Randomized Trials: A Methodological Overview. World Neurosurg. 2022 May;161:323-330\u003c/li\u003e\n \u003cli\u003eShetty AS, Chamukuttan S, Nanditha A, Raj RK, Ramachandran A. Reinforcement of adherence to prescription recommendations in Asian Indian diabetes patients using short message service (SMS)\u0026mdash;a pilot study. J Assoc Physicians India. 2011 Nov;59(11):711-4\u003c/li\u003e\n \u003cli\u003eSchroeder, K., Fahey, T., \u0026amp; Ebrahim, S. (2004). How can we improve adherence to blood pressure\u0026ndash;lowering medication in ambulatory care? Systematic review of randomized controlled trials.\u0026nbsp;Archives of internal medicine,\u0026nbsp;164(7), 722-732\u003c/li\u003e\n \u003cli\u003eAmbaw AD, Alemie GA, Mengesha ZB. Adherence to antihypertensive treatment and associated factors among patients on follow up at University of Gondar Hospital, Northwest Ethiopia. BMC public health. 2012 Dec;12(1):1-6.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Table","content":"\u003cp\u003eTable 1: Timepoint for the intervention implementation\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"879\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 181px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eTIMEPOINT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"7\" style=\"width: 698px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSTUDY PERIOD\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSession\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(T0)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSession\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(T1-T6)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSession\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(T7)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSession\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(T8-T12)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSession\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(T13)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSession\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(T14-T17)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSession\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(T18)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" style=\"width: 567px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eENROLMENT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 181px;\"\u003e\n \u003cp\u003eEligibility screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 181px;\"\u003e\n \u003cp\u003eInformed consent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n 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src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" style=\"width: 567px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eINTERVENTIONS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 181px;\"\u003e\n \u003cp\u003eIntervention group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 181px;\"\u003e\n \u003cp\u003eControl group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"8\" style=\"width: 879px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eASSESSMENTS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" style=\"width: 567px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePrimary outcome\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 181px;\"\u003e\n \u003cp\u003eMedication adherence (DOSE nonadherence scale)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" style=\"width: 567px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSecondary outcomes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 181px;\"\u003e\n \u003cp\u003eHealth literacy\u003c/p\u003e\n \u003cp\u003e(STOFHLA test)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n 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style=\"width: 181px;\"\u003e\n \u003cp\u003eClinical \u0026nbsp; \u0026nbsp; outcome\u003c/p\u003e\n \u003cp\u003e(Hb1AC, blood pressure)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n 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style=\"width: 181px;\"\u003e\n \u003cp\u003eQuality of life (EQ5-D scale)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 181px;\"\u003e\n \u003cp\u003eService user satisfaction\u003c/p\u003e\n \u003cp\u003e(PSQ-18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 181px;\"\u003e\n \u003cp\u003eEconomic Questionnaire\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cimg width=\"21\" height=\"21\" src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABUAAAAVCAYAAACpF6WWAAAAAXNSR0ICQMB9xQAAAAlwSFlzAAAOxAAADsQBlSsOGwAAABl0RVh0U29mdHdhcmUATWljcm9zb2Z0IE9mZmljZX/tNXEAAAErSURBVDjLzZQ9CsJAEIXTahAiKHgCJWJtqdFrCHoDbfQAOYG5gkJQIX0qbfUeIoI/NxD0LbxiGdYkBhEHPrKZmbwss7Nj+b5vfRvr56KwJpiCEMR8qvfmx6KwGliCB7iBHdiALd8fjNcyicJa4AjOYAhsEbfpPzOvlSgKq4ITOKg1fSUQgDWfJforYM/8apKoqtkFOJqvD54afS3mMD80isLq/GggftQWom0RH9DfMInOwB0UQBl4oAMmQnRCv8e8Ar+bmURVzbZcB0LoHQHzVVesTaKqDzdcRxlFI+ardotNoittp/OMonNtp6u0mqpT7bJ244SaOmk1/f7pJ/RpL3ef5rxRh9QbZbj7I1AU8SL92e6+mFILTqOrmFLXj6eUEHffzFP3vyZ/Xl6gZN9qVxJFxgAAAABJRU5ErkJggg==\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" src=\"data:image/png;base64,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\" alt=\"Medical\"\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cimg width=\"22\" height=\"22\" 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AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Medication adherence, Peer group therapy, Community-based participatory research (CBPR), Diabetes, Hypertension, India","lastPublishedDoi":"10.21203/rs.3.rs-5772282/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5772282/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: According to the WHO, more than 50% of patients do not take their medications as prescribed. Nonadherence is caused by several variables, such as social and economic factors, issues with the healthcare team and system, problems relating to specific diseases, characteristics of those diseases, and their treatments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective\u003c/strong\u003e: To study the effectiveness of PARTICIPATE intervention at community level regarding medication adherence among diabetes and/or hypertension adults in rural India.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy design\u003c/strong\u003e: This is a multicenter cluster randomized trial implemented across 04 blocks (64 villages) of 04 districts in East, West, North, and South India, and will cover 2880 randomly selected participants, with a nested economic evaluation to measure the effectiveness of community-based participatory research (CBPR). The intervention will be delivered by peer educators identified from the community for the duration of 12-month with the first 6 months, followed by once monthly for the next 6 months, and the control group continue to receive all aspects of standard care offered by healthcare providers (public or private).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: The measure of drug adherence for hypertension and/or diabetes, as determined by the self-reported Morisky Medication Adherence Scale (MMAS-8) at baseline, midterm, and end, is the study's outcome variable. The independent variables, viz., socio-economical and number of antihypertensive and/or antidiabetic drugs and their duration, self-perceived health status, systolic and diastolic blood pressure and/or HbA1c, will becontrolled while doing the analysis. Secondary outcomes include improvement in health literacy using All Aspects of Health Literacy Scale (AAHS), clinical outcomes, quality of life using EURO-QoL (EQ-5D), cost-effectiveness and return on investment (ROI). Process evaluations will be conducted with a sub-sample of participants to examine engagement in various intervention components. The fidelity of intervention will be monitored using the Normalisation Process Theory framework.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e: To the best of our knowledge, this is the first multi-centre cluster randomized controlled trial in India to assess the effectiveness of CBPR approach for improving medication adherence among diabetics and hypertensives. The results of this study will contribute to the evidence of scaling-up peer-educator models for diabetes and hypertension management in India and similar low-and middle-income countries.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e: The registration number for this trial is CTRI/2024/01/061939\u003c/p\u003e","manuscriptTitle":"Effectiveness of peer-group therapy using community based participatory research model on medication adherence among patients of diabetes and/or hypertension: Study protocol for a multi-centercluster randomized trial in rural settings across India (PARTICIPATE study)","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-22 10:19:31","doi":"10.21203/rs.3.rs-5772282/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-08-14T07:54:17+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-08-14T07:54:01+00:00","index":"","fulltext":""},{"type":"decision","content":"Major revision","date":"2025-08-14T04:02:18+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-07-10T10:52:32+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-07-08T10:41:40+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5802487c-ba2c-4311-84dc-e999c53df8ab","owner":[],"postedDate":"August 22nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-11-10T16:00:19+00:00","versionOfRecord":{"articleIdentity":"rs-5772282","link":"https://doi.org/10.1186/s13063-025-09209-7","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2025-11-06 15:57:19","publishedOnDateReadable":"November 6th, 2025"},"versionCreatedAt":"2025-08-22 10:19:31","video":"","vorDoi":"10.1186/s13063-025-09209-7","vorDoiUrl":"https://doi.org/10.1186/s13063-025-09209-7","workflowStages":[]},"version":"v1","identity":"rs-5772282","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5772282","identity":"rs-5772282","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}