An early-stage cost and implementation feasibility study of the administration of pro/synbiotics to infants 0-5 months in rural Kenya

An early-stage cost and implementation feasibility study of the administration of pro/synbiotics to infants 0-5 months in rural Kenya | medRxiv /* */ /* */ <!-- <!-- /*! * yepnope1.5.4 * (c) WTFPL, GPLv2 */ (function(a,b,c){function d(a){return"[object Function]"==o.call(a)}function e(a){return"string"==typeof a}function f(){}function g(a){return!a||"loaded"==a||"complete"==a||"uninitialized"==a}function h(){var a=p.shift();q=1,a?a.t?m(function(){("c"==a.t?B.injectCss:B.injectJs)(a.s,0,a.a,a.x,a.e,1)},0):(a(),h()):q=0}function i(a,c,d,e,f,i,j){function k(b){if(!o&&g(l.readyState)&&(u.r=o=1,!q&&h(),l.onload=l.onreadystatechange=null,b)){"img"!=a&&m(function(){t.removeChild(l)},50);for(var d in y[c])y[c].hasOwnProperty(d)&&y[c][d].onload()}}var j=j||B.errorTimeout,l=b.createElement(a),o=0,r=0,u={t:d,s:c,e:f,a:i,x:j};1===y[c]&&(r=1,y[c]=[]),"object"==a?l.data=c:(l.src=c,l.type=a),l.width=l.height="0",l.onerror=l.onload=l.onreadystatechange=function(){k.call(this,r)},p.splice(e,0,u),"img"!=a&&(r||2===y[c]?(t.insertBefore(l,s?null:n),m(k,j)):y[c].push(l))}function j(a,b,c,d,f){return q=0,b=b||"j",e(a)?i("c"==b?v:u,a,b,this.i++,c,d,f):(p.splice(this.i++,0,a),1==p.length&&h()),this}function k(){var a=B;return a.loader={load:j,i:0},a}var l=b.documentElement,m=a.setTimeout,n=b.getElementsByTagName("script")[0],o={}.toString,p=[],q=0,r="MozAppearance"in l.style,s=r&&!!b.createRange().compareNode,t=s?l:n.parentNode,l=a.opera&&"[object Opera]"==o.call(a.opera),l=!!b.attachEvent&&!l,u=r?"object":l?"script":"img",v=l?"script":u,w=Array.isArray||function(a){return"[object Array]"==o.call(a)},x=[],y={},z={timeout:function(a,b){return b.length&&(a.timeout=b[0]),a}},A,B;B=function(a){function b(a){var a=a.split("!"),b=x.length,c=a.pop(),d=a.length,c={url:c,origUrl:c,prefixes:a},e,f,g;for(f=0;f<d;f++)g=a[f].split("="),(e=z[g.shift()])&&(c=e(c,g));for(f=0;f<b;f++)c=x[f](c);return c}function g(a,e,f,g,h){var i=b(a),j=i.autoCallback;i.url.split(".").pop().split("?").shift(),i.bypass||(e&&(e=d(e)?e:e[a]||e[g]||e[a.split("/").pop().split("?")[0]]),i.instead?i.instead(a,e,f,g,h):(y[i.url]?i.noexec=!0:y[i.url]=1,f.load(i.url,i.forceCSS||!i.forceJS&&"css"==i.url.split(".").pop().split("?").shift()?"c":c,i.noexec,i.attrs,i.timeout),(d(e)||d(j))&&f.load(function(){k(),e&&e(i.origUrl,h,g),j&&j(i.origUrl,h,g),y[i.url]=2})))}function h(a,b){function c(a,c){if(a){if(e(a))c||(j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}),g(a,j,b,0,h);else if(Object(a)===a)for(n in m=function(){var b=0,c;for(c in a)a.hasOwnProperty(c)&&b++;return b}(),a)a.hasOwnProperty(n)&&(!c&&!--m&&(d(j)?j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}:j[n]=function(a){return function(){var b=[].slice.call(arguments);a&&a.apply(this,b),l()}}(k[n])),g(a[n],j,b,n,h))}else!c&&l()}var h=!!a.test,i=a.load||a.both,j=a.callback||f,k=j,l=a.complete||f,m,n;c(h?a.yep:a.nope,!!i),i&&c(i)}var i,j,l=this.yepnope.loader;if(e(a))g(a,0,l,0);else if(w(a))for(i=0;i (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];var j=d.createElement(s);var dl=l!='dataLayer'?'&l='+l:'';j.src='//www.googletagmanager.com/gtm.js?id='+i+dl;j.type='text/javascript';j.async=true;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-P4HH5NV'); Skip to main content Home About Submit ALERTS / RSS Search for this keyword Advanced Search An early-stage cost and implementation feasibility study of the administration of pro/synbiotics to infants 0-5 months in rural Kenya Beth McCallum , Iwaret Otiti , Florence Achieng , View ORCID Profile Stephen Allen , Eve Worral doi: https://doi.org/10.1101/2024.12.17.24319142 Beth McCallum 1 Department of Clinical Sciences, Liverpool School of Tropical Medicine , Pembroke Place, Liverpool, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site For correspondence: bethmccallum{at}gmail.com Iwaret Otiti 2 Malaria Branch, Kenya Medical Research Institute (KEMRI) Centre for Global Health Research , P.O. Box 1578, 40100 Kisumu, Kenya Find this author on Google Scholar Find this author on PubMed Search for this author on this site Florence Achieng 2 Malaria Branch, Kenya Medical Research Institute (KEMRI) Centre for Global Health Research , P.O. Box 1578, 40100 Kisumu, Kenya Find this author on Google Scholar Find this author on PubMed Search for this author on this site Stephen Allen 1 Department of Clinical Sciences, Liverpool School of Tropical Medicine , Pembroke Place, Liverpool, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Stephen Allen Eve Worral 1 Department of Clinical Sciences, Liverpool School of Tropical Medicine , Pembroke Place, Liverpool, UK Find this author on Google Scholar Find this author on PubMed Search for this author on this site Abstract Full Text Info/History Metrics Data/Code Preview PDF Abstract Background Undernutrition underlies approximately 45% of global deaths among children less than five years old, making it one of the most concerning global child health issues. The PRO biotics and SYN biotics in infants in K enya (PROSYNK) trial is assessing whether supervised doses of pro/synbiotics daily for the first 10 days and then weekly to age 6 months (total of 32 doses), has a positive impact on gut health and thereby growth and nutrition. This study is an early-stage cost and implementation feasibility study defining unit costs for the PROSYNK trial and estimating programmatic cost and feasibility of delivering the intervention to infants in rural Kenya. Methods This provider perspective costing study uses a combination of ingredients approach, activity-based costing and microcosting. First, an empirical cost analysis of the PROSYNK trial was conducted by review of trial documentation and time and motion observations. Next, semi-structured interviews with key informants informed a thematic analysis of implementation feasibility and the development of a theoretical programme structure which formed the basis for estimation of total economic programme costs. Results The economic cost of delivering the full pro/synbiotics course under trial conditions was measured as $757.32 per participant. Experience gained during PROSYNK and discussions with key informants revealed that it was feasible for the Ministry of Health (MoH) to implement programmatic delivery of the pro/synbiotics, particularly through community-based delivery, without a cold chain and with pro/synbiotic administered directly into infant’s mouths. Incremental economic costs to the MoH of delivering the pro/synbiotic programmatically were estimated to be $9.15 per infant per full course under the base case scenario. Conclusion Pro/synbiotic administration in early life may be feasible and bear similar costs to existing nutrition interventions. This study will provide policy makers and stakeholders with vital cost and feasibility information to inform effective programmatic implementation in Kenya and similar settings. Background Malnutrition is one of the most concerning global child health issues, with approximately 45% of worldwide deaths among children less than five years old attributable to undernutrition [ 1 ]. Children with impaired linear growth, characterised by stunting, also experience suboptimal organ development and cognitive and immune system functioning [ 2 ]. Stunting has lifelong and intergenerational socioeconomic consequences, with 43% of children under five in low- and middle-income countries (LMICs) at a greater risk of poverty due to stunting [ 3 ]. Children who experience stunting typically earn 20% less income than their non stunted counterparts in adult life [ 4 ]. Despite global efforts, the slow decline in the prevalence of stunting highlights the need for further research and continued efforts to combat this issue [ 5 ]. PROSYNK ( PRO biotics and SYN biotics in infants in K enya) is an intervention trial assessing whether administering pro/synbiotics to newborns daily for the first 10 days and then weekly to age five months (total of 32 doses) in Homa Bay county, western Kenya improves gut health and thereby growth and nutrition [ 6 ]. Newborns are randomised to one of four study arms, either a probiotic, one of two synbiotics or control (no intervention). Pro/synbiotics are maintained in a central refrigerator in the Homa Bay Hospital Department of Pharmacy with each dose transported in a cold box by research staff on motorbikes to children’s homes and administered under supervision [ 7 ]. Pro/synbiotics are administered either directly into the infant’s mouth or after mixing with sterile water in a medicine cup. Economic evaluations and implementation feasibility research provide invaluable insights that lay the groundwork for more effective allocation of resources, ultimately leading to enhanced overall health outcomes. This paper provides an early-stage cost analysis of the PROSYNK intervention and considers the feasibility and estimated cost of real-world implementation. It provides context-specific evidence for Homa Bay County where the trial was undertaken. Methods The processes and methods employed to administer pro/synbiotics during the first 0-5 months in infants in Homa Bay County, western Kenya, in the context of a randomised clinical trial have been reported previously [ 7 ]. Trial costing Data were collected from the PROSYNK trial site, as well as remotely (virtually) from the UK. The remote collection was necessitated by COVID-19 travel restrictions in place at the time. Costing was carried out using a combination of activity-based costing (ABC) and the ingredients approach. This involved identifying activities required to deliver the intervention followed by estimating the quantity and unit cost of the resources (or ‘ingredients’) required for each activity [ 8 ]. Data collection consisted of trial documentation review and semi-structured interviews with trial key informants. Initial data collection informed the creation of a comprehensive costing spreadsheet outlining trial activities, subactivities (for activities being microcosted only), and resources used for each of these. Activities were categorised as either trial research costs (TRC) or trial intervention delivery costs (TIDC) by key informants, which allowed research-specific costs to be separated. Activities, subactivities, and ingredients were then shared for review with trial management to check for errors or omissions. Data for each resource used in the trial were outlined on the costing spreadsheet, including a broad cost category (cost category 1), specific cost category (cost category 2), cost type (capital/not-capital), unit type, unit quantity, unit cost, percentage of resources allocated to activity, and useful life of resources. The percentage of each resource allocated to activities was also defined by trial documentation review and trial personnel interviews (e.g., a study vehicle utilised across several activities may be used 80% of the time for the activity “home visits” and 20% of the time for another activity). Given that personnel time spent delivering the intervention was expected to be a key cost driver, time and motion (TAM) observations were carried out for activities ‘home visits’ and ‘clinic visits’ to facilitate more accurate costing. Resources were assigned financial costs based on trial expenditure records and confirmed, where possible, with secondary publicly available sources (e.g., manufacturers’ prices of items). Resources were valued using appropriate market rates such as current rent and vehicle purchase costs. Resource values were assigned in the currency used, most often in Kenyan Shillings (KES) and British Pounds (£GBP). KES and £GBP costs were calculated for each item which were subsequently converting to 2021 US dollars ($USD) using respective mean exchange rates for 2021 [ 9 ] at the time of study analysis. In line with World Health Organization (WHO) costing guidance, a standard discount rate of 3% was used for economic costs to account for the opportunity cost of capital assets [ 10 ] Discount rate and useful life were used to calculate annualisation factors for capital items. These inputs are outlined for each resource on the costing spreadsheet (available on reasonable request). Annualisation factors were then used to obtain annual economic costs of capital goods. The trial costing spreadsheet was used to calculate total trial cost which is defined as the total annualised economic cost of delivering the intervention to all trial participants over a period of one year . This is presented in $USD. Financial costs and results in other currencies (£GBP and KES) are available as supplementary material. Feasibility and Theoretical Programme Structure Semi-structured interviews with trial field workers, trial management, local healthcare workers and relevant experts and informed a thematic analysis of implementation feasibility and the development of a Theoretical Programme Structure (TPS). Interview guides were developed for each of four key informant types. The themes explored included overall feasibility, health system capacity, delivery and logistics, administration safety and ease, acceptability, potential challenges, supply chain, and stakeholders. Sections of interview transcripts were coded into the above themes. This allowed themes to be analysed across all transcripts and synthesised to explore themes in detail and identifies aspects of programmatic delivery considered to be the most and least feasible. Using contributions from key informants, the TPS outlined a potential delivery method with a staffing and resource structure that would be required for the Ministry of Health (MoH) to carry out programmatic implementation of pro/synbiotic delivery across Homa Bay County. Estimated programme costs Scaled-up programmatic costs for the TPS were estimated from the provider (MoH) perspective. Costs were estimated under a base case scenario using the delivery method identified as the most realistic and feasible based on key informant discussions. The base case scenario was defined as follows: initial pro/synbiotic supply and education on how to administer these given to mothers by Community Health Workers (CHWs) (or equivalent role) coinciding with their existing routine postnatal home visits for the first 3 days, with resupply of pro/synbiotics monthly coinciding with existing routine child health clinic visits carried out by clinical officers (or nursing staff). Additional scenario analysis (such as utilising a cold chain or extra consumables for pro/synbiotic administration) is discussed further below. An estimated costing sheet was developed to obtain programmatic cost estimates. Input variables (including those associated with the operational elements outlined above) used to obtain programme cost estimates were derived either from empirical data measured in trial settings, secondary data, or based on assumptions. Input variables are outlined in supplementary material ( Supplementary Table 1 , Additional File 1). Programmatic costs were estimated using the same methods regarding currency, discount rate, resource valuation and annualisation as outlined above for trial costs. Cost estimates are presented as economic incremental costs (the additional cost to the MoH above the standard of care (SoC)) of implementing programmatic pro/synbiotic delivery to all infants in Homa Bay County per year in $USD. Unit costs were calculated defined as follows: Cost per pro/synbiotic = estimated total economic incremental cost above the SoC to the MoH of delivering one pro/synbiotic to one infant in Homa Bay County. Cost per course = estimated total economic incremental cost above the SoC to the MoH of delivering one full course of pro/synbiotics (total of 32 doses) to one infant in Homa Bay County. Financial costs and results in £GBP are available as supplementary material. Uncertainty and scenario analysis As in any cost analysis uncertainty and alternative scenarios will affect costs; this was explored in scenario and uncertainty analysis. Input variables for the base case scenario underwent one-way sensitivity analysis to assess the extent of their impact on total programme costs. Programmatic costs were also estimated under different scenarios varying in operational elements that impact the cost and/or feasibility of delivery. Operational elements varied were: the use of a cold chain in pro/synbiotic supply and distribution, and the use of consumables (e.g., medicine cup, sterile water) in administration of pro/synbiotics. Results Trial costs were calculated as shown in Table 1 . Detailed trial costing results (including financial costs, reporting in other currencies, and further breakdown of cost categories) are available in Supplementary Table 2 , Additional File 1. View this table: View inline View popup Table 1: Total Trial Costs Programmatic Feasibility Key informants considered that it would be feasible for the MoH to carry out programmatic delivery of pro/synbiotics, particularly through community-based delivery coinciding with routine postnatal care. Detailed thematic analysis results are available ( Supplementary Table 4 , Additional File 1). The Theoretical Programme Structure was developed as shown in Figure 1 . Download figure Open in new tab Fig. 1: Theoretical Programme Structure *Community Health Assistant † Community Health Volunteer ‡ Maternal and Child Health Programme cost estimates Programme cost estimates under base case scenario input variables are outlined in Table 2 . View this table: View inline View popup Download powerpoint Table 2: Estimated programme cost of county-wide delivery Uncertainty and scenario analysis Sensitivity analysis presents the three most impactful variables considered ( Figure 2 ) and highlights that the cost per pro/synbiotic had, by far, the most significant impact on programme costs. On analysis and costing of varying scenarios, administration method was identified as another very significant factor impacting estimated programme costs. This was due to the differences in consumables required to administer the pro/synbiotic. Lower programme costs were associated with administration directly into the infant’s mouth (as utilised in the base case), as this does not require any additional consumables. This is in contrast to mixing the pro/synbiotic in a container with sterile water before administering, for which costs were estimated using a medicine cup and a small amount of sterile water for each of the 32 doses. The scenario using consumables for the administration of the pro/synbiotic therefore showed an increase in estimated total programme costs, with cost per course increasing from $9.25 to $47.32 (base case using direct administration). Conversely, the scenario utilising a cold chain for supply and distribution of pro/synbiotics resulted only in a modest cost increase, increased the cost per course from $9.25 (base case using ambient supply chain) to $9.61 (with cold chain). Estimated programme costs for these varying scenarios and more detailed base case costing (including financial costs and presenting in £GBP) are available as supplementary material ( Supplementary Tables 5 - 7 , Additional File 1). Download figure Open in new tab Fig. 2: Sensitivity analysis Discussion We conducted a cost analysis of the PROSYNK trial which showed total trial cost of $202,964. Interviews indicated that key stakeholders consider the intervention to be feasible and were used to define a TPS with defined staffing. This, along with trial cost data was used to estimate cost of a base case which was estimated to cost $9.15 per course per infant and $0.29 per pro/synbiotic per infant. Scenario analysis revealed that costs increased by 417% with administration via a cup. Use of cold chain increased costs by 5%. Administration of pro/synbiotics may have significant health benefits in early life [ 6 ]. This analysis shows that administration in the community as part of routine child health services in Kenya, without the use of a cold chain and with administration directly into infants mouths, may be affordable with an estimated cost per 6-month course (32 dose) per infant of USD $9.15. The results of this study will guide future research (ideally with embedded cost-effective analysis) and offer policymakers and stakeholders valuable insights into cost and feasibility for potential implementation, informing efficient intervention design. Decentralisation in Kenya also indicates that the results of this study will be especially useful to Homa Bay County, as counties have their own budgets and can allocate them to relevant priorities. Homa Bay County has a dispersed rural population and poverty rates above the national average [ 11 , 12 ]. Therefore, it can be logistically and financially difficult for individuals to attend facilities [ 13 ]. For this reason, key informants considered that community-based delivery led by CHVs (without the use of a cold chain) was the most feasible. The use of CHVs for similar interventions has been shown to be cost-effective and improve healthcare coverage, particularly in rural areas [ 14 – 19 ] such as Homa Bay County. The role of CHVs in pro/synbiotic delivery would be expected to include delivery of an initial supply of pro/synbiotics and teaching on how to administer these coinciding with existing routine postnatal home visits for the first 3 days (as was utilised in the estimation of programme costs). The point estimates for economic and financial programme costs were $381,320.58 and $359,171.84, respectively. Pre-existing resources already owned by the MoH used in programme delivery, such as clinic space and staff, have no financial cost and bare only economic costs; these resources account for much of the difference between economic and financial costs. Economic costs include the opportunity cost of utilising pre-existing resources for programmatic delivery and, therefore, are more representative of the resources (rather than finances) needed, as it does not assume pre-existing resources to be “free”. Sensitivity analysis showed that total programme costs were very sensitive to the cost per pro/synbiotic. Cost per pro/synbiotic is a particularly important variable to consider, particularly as the ongoing PROSYKN trial is currently investigating three distinct formulations (each bearing different costs). This highlights the importance of further investigation, if the intervention is shown to be effective, to determine which pro/synbiotic formulation would be used. This also highlights how reductions in cost when buying in bulk for programmatic delivery has the potential to significantly reduce programmatic costs. Other variables, such as healthcare worker time spent on pro/synbiotic delivery, fee for warehousing and distribution, and costs of training and initiation, were also examined. However, these factors had a very modest impact on total estimated costs compared to the cost per pro/synbiotic. A substantial difference in estimated program costs were observed between different administration methods. Specifically, the scenario utilising consumables (e.g., mixing cups and sterile water which was included in the PROSYNK trial) to administer the pro/synbiotic resulted in a large increase in costs from the base case scenario, where the pro/synbiotic would be administered directly into the infant’s mouth. Direct administration not only bares lower estimated costs but was also considered to be highly feasible and realistic. Experience from the PROSYNK trial indicated that direct administration to infants was preferred by many mothers, suggesting its potential adoption as the primary delivery method outside of a trial context. Although less impactful on estimated costs than some of the other variables considered, the use of a cold chain was highlighted during key informant interviews as an operational element which could significantly reduce the feasibility of programmatic implementation. Additional costs incurred when utilising a cold chain were due to capital purchases (fridges, cool boxes) and an increased fee from Kenya Medical Supplies Agency (KEMSA, the government medical logistics provider contracted by county governments to delivery medical commodities) for procurement, warehousing, and distribution under a cold chain. However, stability testing of the pro/synbiotics at ambient temperatures in Kenya indicate that a cold chain would not be required (K. Otieno; personal communication). Unit costs of existing interventions may provide context for nutrition spending in Kenya. Some financial unit costs (per beneficiary per year) in Kenya are reported by The World Bank [ 20 ] as follows: vitamin A supplementation ($0.44), therapeutic zinc supplementation with ORS ($1.34), multiple micronutrient powders ($2.00), public provision of complementary food for prevention of moderate acute malnutrition ($47.99), and treatment of severe acute malnutrition ($83.32). The programmatic financial unit cost of delivering one full course of pro/synbiotics to one infant was estimated to be $8.62 under base case conditions in our study (this was $9.15 when considering economic costs, which the world bank examples do not). This is within a similar cost range to these existing interventions. Cost-effectiveness analysis is the preferred economic analysis method to evaluate interventions but, as the PROSYNK trial is ongoing, the effectiveness of the intervention is not yet known, precluding a cost-effectiveness analysis. Further, cost estimates presented for the PROSYNK intervention are based on costs of undertaking a limited research project under trial conditions. Due to highly regulated research conditions trial costs are not representative of routine intervention delivery costs, and our estimated costs did not consider potential reduced costs when buying in bulk (for both pro/synbiotic and consumables) for programmatic delivery. However, our methodology used key informant interviews to try and adapt these data to a realistic programmatic delivery costing. This study took the provider perspective. A societal perspective, which considers the financial and economic cost to participants, would be best practice. Many economic analyses in LMICs highlight important opportunity costs incurred by beneficiaries of existing community-based nutrition programmes [ 13 ]. Therefore, it would be crucial to also consider costs to beneficiaries in future research and if the intervention were to be delivered programmatically (particularly when considering and comparing possible delivery mechanisms). To overcome these limitations, we recommend an embedded cost-effective analysis in further studies that take forward the findings from the PROSYNK trial. Conclusion Prioritising effective implementation of interventions to improve nutrition that have been proven to be affordable and feasible using context-specific data grounded in local healthcare systems is critical to ensuring improved health outcomes. Despite methodological limitations that could be addressed in follow-on studies, these results suggest that pro/synbiotic administration in early-life is an affordable intervention when delivered at scale. Opting for community-based delivery without a cold chain and pro/synbiotic administration directly into infants mouths would minimise provider costs and enhance feasibility. Data Availability All data produced in the present study are available upon reasonable request to the authors Declarations Ethics approval and consent to participate The PROSYNK trial, and subsequently this study, ensured compliance with the Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (World Medical Association, 2013) and all applicable local regulatory requirements in Kenya. Ethical approval was granted by ethics committees at the Liverpool School of Tropical Medicine (LSTM; 20(09)) and Kenya Medical Research Institute (KEMRI; KEMRI/SERU/CGHR/320/3917). There were no deviations from the approved study protocol. Consent for publication N/A Availability of data and materials The datasets supporting the conclusions of this article are available from the corresponding author on reasonable request. Competing Interests The authors declare that they have no competing interests. Funding The PROSYNK trial is funded by the Children’s Investment Fund Foundation; no additional funding was available for this economic analysis. Authors Contributions SA and EW conceptualised and all authors designed the study. BM and FA collected data. BM analysed the data with supervision from EW. BW wrote the first draft, EW and SA provided important edits. All authors read and approved the final manuscript. Footnotes View this table: View inline View popup Supplementary Table 1: Input variables for estimated programme costs View this table: View inline View popup Supplementary Table 2: Trial Activities, Costing Methods, and Categorisation View this table: View inline View popup Download powerpoint Supplementary Table 3: Trial cost categories, all currencies View this table: View inline View popup Supplementary Table 4: Thematic analysis results View this table: View inline View popup Download powerpoint Supplementary Table 5: Estimated programme cost of county-wide delivery: base case scenario View this table: View inline View popup Download powerpoint Supplementary Table 6: Estimated programme costs scenarios analysis: administration method View this table: View inline View popup Download powerpoint Supplementary Table 7: Estimated programme costs scenarios analysis: cold chain Republic of Kenya Ministry of Health (MoH), Homa Bay County, Health at a Glance . 2015. Institute for Health Metrics and Evaluation (IHME). Kenya - HomaBay . 2019 13 August 2021]; Available from: http://www.healthdata.org/kenya-homabay . County Innovation Challenge Fund (CICF), Ubuntu-Afya Kiosks: An innovative partnership for extending quality healthcare services to underserved communities 2019. Republic of Kenya Ministry of Health (MoH), Health Sector HRH Strategy 2014 – 2018 . 2014. Acknowledgements We thank the key informants for their valuable insights into the operational aspects of pro/synbiotic delivery in communities in Kenya. List of Abbreviations ABC Activity-based costing CHA Community health assistant CHV Community health volunteer GBP Great British Pounds KEMRI Kenya Medical Research Institute KES Kenyan Shillings LMICs Low- and middle-income countries LSTM Liverpool School of Tropical Medicine MCH Maternal and Child Health MoH Ministry of Health PROSYNK PRObiotics and SYNbiotics in infants in Kenya SoC Standard of Care TAM Time and motion TIDC Trial intervention delivery costs TPS Theoretical programme structure TRC Trial research costs USD US Dollars WHO World Health Organization KEMSA Kenya Medical Supplies Authority References 1. ↵ Black RE , Victora CG , Walker SP , Bhutta ZA , Christian P , de Onis M , et al. Maternal and child undernutrition and overweight in low-income and middle-income countries . The Lancet . 2013 ; 382 : 427 – 51 . OpenUrl CrossRef 2. ↵ Stunting in a nutshell . World Health Organization . 2015 . https://www.who.int/news/item/19-11-2015-stunting-in-a-nutshell . 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