A randomized controlled, trial on effects of mobile phone text messaging in combination with motivational interviewing versus standard infant feeding counselling on breastfeeding and child health outcomes, among women living with HIV

A randomized controlled, trial on effects of mobile phone text messaging in combination with motivational interviewing versus standard infant feeding counselling on breastfeeding and child health outcomes, among women living with HIV | 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 A randomized controlled, trial on effects of mobile phone text messaging in combination with motivational interviewing versus standard infant feeding counselling on breastfeeding and child health outcomes, among women living with HIV Moleen Zunza, Lehana Thabane, Louise Kuhn, Christine Els, Carl Lombard, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5132328/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 20 Jan, 2025 Read the published version in International Breastfeeding Journal → Version 1 posted 11 You are reading this latest preprint version Abstract Introduction Breastfeeding improves child health, development and survival, particularly in regions where diarrhoea, pneumonia and undernutrition are leading causes of death in children under five. Despite awareness of exclusive breastfeeding benefits and efforts to promote optimal infant feeding practices, the practice of exclusive breastfeeding is low. We conducted a trial to determine whether text messaging plus motivational interviewing increase uptake of exclusive breastfeeding, prolong exclusive breastfeeding and improve child health outcomes. Methods We conducted the trial between July 2022 and May 2024, at a secondary-level healthcare facility in South Africa. Mothers living with HIV and their infant, initiating breastfeeding, on cART, 18 years or older, were randomly assigned to either weekly text messaging plus in-person motivational interviewing or standard infant feeding counselling for six months. The randomization allocation sequence was computer generated and assignment was done centrally. Results Mother-child pairs (n = 276) were randomly allocated to receive intervention (n = 138) or standard infant feeding counselling. One hundred five and 101 mother-child pairs in the intervention group and standard care group, respectively, had primary outcome data evaluation across all four study visits. We found no significant effect of the intervention on exclusive breastfeeding rates at week 24, (6% versus 7%), rate difference − 1% (95% CI -6–4%). Sixty-two of 276 (22%) mother-child pairs completely stopped breastfeeding before week 24. The most common reasons for stopping breastfeeding were the mother needing to return to work or look for work, 66% (n = 41). We also found that early breastfeeding cessation increased risk of child hospitalization or death compared to any form of breastfeeding to week 24, 10% (5/48) versus 3% (5/158), p = 0.055. Conclusion Socio-economic pressures influenced mothers’ decision to stop breastfeeding. Introduction of other foods before six months while breastfeeding remains common. Early cessation of breastfeeding is a public health threat. While finding interventions to enhance exclusive breastfeeding remains critical, HIV services should reliably offer cART, consistently monitor viral load, and support mothers cART adherence, especially where mixed feeding is common. Innovative interventions responsive to socio-economic challenges faced by mothers of reproductive and working age may be more effective in improving exclusive breastfeeding rates. Breastfeeding HIV/AIDS mobile phone text messaging motivational interviewing Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction Breastfeeding improves a child’s health, development and survival, offering significant social and economic benefits, particularly where diarrhoea, pneumonia and undernutrition are leading causes of death in children under five[ 1 ] [ 2 ] [ 3 ]. Exclusive breastfeeding could prevent 13% of under-five deaths annually in low- and middle-income settings[ 4 ] [ 5 ]. The World Health Organization (WHO) recommends exclusive breastfeeding for the first six months of life, followed by continued breastfeeding with appropriate complementary foods for two years or longer[ 1 ] [ 6 ]. Optimal treatment with combination antiretroviral treatment (cART) has reduced the risk of mother-to-child transmission (MTCT) of HIV rates below 2% [ 7 ]. Adherence to cART and breastfeeding exclusively [ 8 ] can reduce postpartum vertical transmission of HIV and lower under-five all-cause death [ 9 ][ 10 ][ 11 ]. In contrast, mixed feeding is associated with increased risk of vertical transmission of HIV and higher under-five death and morbidity if mothers are not on cART [ 12 ] [ 13 ]. Despite awareness of exclusive breastfeeding benefits and efforts to promote optimal infant feeding, the practice of exclusive breastfeeding is low in sub-Saharan Africa[ 14 ][ 15 ]. In sub-Saharan Africa, only 37% of infants under 6 months are exclusively breastfed [ 5 ]. Exclusive breastfeeding rates are below 50%, the global target[ 16 ]. Exclusive breastfeeding among South African mothers improved in recent years, but remains below global targets, with 32% of infants exclusively breastfed for the first six months [ 15 ], however, regional disparities in breastfeeding practices remains. Early breastfeeding cessation and mixed feeding before six months of age are common practices [ 17 ]. The 2016 South Africa Demographic and Health survey found that among children aged 0–5 months, 25.2% were never breastfed, 11.4% were receiving breastmilk and other milk, and 17.6% received complementary feeds [ 18 ]. Approximately, 40% of mothers living with HIV in South Africa stop breastfeeding before 12 weeks [ 17 ]. In Kenya, approximately 59% of HIV-exposed infants under 6 months are exclusively breastfed, and only 32% are breastfed up to one year [ 19 ]. Sub-optimal feeding practices are associated with vertical transmission of HIV[ 20 ] [ 21 ]. Mothers living with HIV fear transmitting HIV to infants leading to sub-optimal infant feeding practices[ 22 ][ 23 ]. For the same reason, some healthcare providers, discourage breastfeeding [ 24 ]. South Africa is one of the countries with the highest burden of HIV [ 25 ]. Due to high prevalence of HIV pregnancy (30.8%)[ 26 ], the South African Government prioritized elimination of vertical HIV transmission [ 27 ]. Prior to 2011, South African infant feeding policy recommended exclusive formula feeding [ 27 ]. All public healthcare facilities provided free infant formula to mothers living with HIV until 6 months of age [ 27 ]. In October 2012, South Africa adopted the WHO 2010 guidelines, promoting exclusive breastfeeding only [ 27 ]. Despite the counselling on infant-feeding offered at primary healthcare facilities and many interventions to promote optimal infant feeding, practices remain suboptimal [ 23 ][ 28 ]. Studies showed that infant feeding counselling improves infant feeding practices in South Africa [ 29 ]. Mobile phone text messaging, a simple, low-cost intervention, improves medication adherence among patients with HIV, diabetes, and tuberculosis[ 30 ][ 31 ] [ 32 ]. Motivational interviewing, a patient-centred non-coercive approach [ 33 ], is beneficial across many health problems, including HIV viral load suppression, weight loss, and alcohol and tobacco use, and medication adherence among patients with HIV and tuberculosis. There are different factors at multiple levels preventing mothers from following recommended infant feeding practices, leading to early breastfeeding cessation or mixed feeding during the first 6 months, particularly in low- and middle-income countries[ 14 ]. Infant feeding cultural norms, stigma, inadequate counselling and limited financial resources, and infant feeding knowledge are among the factors influencing infant feeding choices of mothers living with HIV [ 34 ][ 35 ][ 36 ]. In South Africa, the shift from exclusively using formula feeding and provision of free formula milk to promoting exclusive breastfeeding resulted in healthcare provides often giving insufficient or contradictory advice [ 37 ]. While some mothers follow healthcare providers’ advice on infant feeding, others find it challenging due to individual circumstances [ 34 ][ 35 ][ 36 ]. Significant gaps still exist in developing innovative strategies to support breastfeeding in environments with low exclusive breastfeeding rates. The trial objective was to demonstrate the superiority of mobile phone text messaging in combination with motivational interviewing over standard infant feeding counselling in increasing week 24 exclusive- and any form of -breastfeeding rates, reducing risk of child hospitalization or death and improving linear growth. Study methods and design Trial design We previously described the study methods [ 38 ]. Briefly, we conducted a parallel group, standard care-controlled randomized trial evaluating infant feeding practices at four follow up visits, among 276 mother-child pairs. We randomly assigned participants to either weekly mobile phone text messaging plus in-person motivational interviewing or to standard infant counselling for 24 weeks. The principal investigator used Stata 17 random number generating command (RALLOC), to generate the randomization allocation sequence restricted by permuted block sizes of 2, 4 and 6, with a 1:1 allocation ratio. A research assistant enrolled study participants, collected baseline data using the Research Electronic Data Capture (REDCap) mobile application and uploaded the data to the REDCap online server. The principal investigator assigned study group sequentially, using the locked unmodifiable allocation sequence stored on the REDCap online server. A research assistant not administering the study interventions completed outcome evaluation questionnaires at follow up visits, without knowledge of group assignment. A different research assistant administered the study interventions. An independent data analyst performed unblinded interim analysis during trial monitoring. Study participants and the principal investigator were aware of the group assignment. This manuscript was written following the Consolidated Standards of Reporting Trials (CONSORT 2010) guidelines for reporting parallel group randomized trial [ 39 ]. Setting and study population Mothers were counselled to exclusively breastfeed for the first 6 months by nurses and trained lay counsellors during routine postnatal clinic visits at their local primary healthcare clinics. Khayelitsha District Hospital provides secondary-level healthcare services. Women were invited to participate within 24 hours of giving birth at Khayelitsha District Hospital and followed for 6 months at Masiphuhlisane Research Centre in Khayelitsha, Cape Town. We enrolled mothers living with HIV, initiating breastfeeding, on cART, 18 years or older, with a mobile phone, and their infants. We excluded mothers who initiated formula feeding within 24 hours of giving birth, gave birth to more than one infant, infant birthweight < 2500 grams or gestational age at birth < 36 weeks. Study interventions Mobile phone text messaging and motivational interviewing A research assistant sent text message weekly to mothers in the intervention group, encouraging exclusive breastfeeding and inquired if there were any breastfeeding problems. The research assistant contacted mothers who indicated a breastfeeding problem and those who failed to respond within 48 hours. Mothers with breastfeeding problems were advised to seek healthcare services at their primary healthcare facilities. Mothers had individual motivational interviews post-delivery at week 2, 6, and 10. During the interviews, the research assistant and the mother discussed breastfeeding practices and problems, potential solutions, reinforced mother’s own self-motivational statements and readiness to correct suboptimal infant feeding practices and affirm the mother’s freedom of choice. Text messaging and motivational interviews were discontinued for mothers who completely stopped breastfeeding before trial conclusion. The mother-child pair who stopped breastfeeding early were followed for the secondary outcomes. Standard care infant feeding counselling Participants in the standard care infant feeding counselling group were counselled by primary healthcare nurses and trained lay counsellors to exclusively breastfeed for the first six months as part of routine healthcare practice. Sample size, power, and detectable differences We expected exclusive breastfeeding rate of 8% at age 6 month in the standard care group[ 13 ]. To detect a difference of 15% between the intervention and standard care groups (i.e., 23% vs 8%), 182 mother-infant pairs were required for a two-sided test traditional fixed sample size computation. Adjusting the sample size for two planned analyses using the O’Brien-Fleming inflation factor 1.01 at the 0.05 significance level and 80% power, we revised the sample size to 182 × 1.01 = 184 and further inflated the sample size by 33% to 275 mother -infant pairs, accounting for loss to follow up. Study measurements and procedures The study included an enrolment maternal interview at Khayelitsha District hospital, four in-person follow-up visits at week 2, 6, 10, and 24, at Masiphuhlisane Research Centre, child medical record review, and child length and weight measurements. Baseline sociodemographic and clinical characteristics were obtained by interviewing the mother and abstracting medical records data. At each visit, a research assistant interviewed the mother using a questionnaire of food items given to the child in the last week or 24 hours preceding the inquiry. Infant death, hospitalization, safety events and other study related data were obtained by interviewing the mother. The study provided transport to and from the study follow up research site; mothers received a R180 (~ US $ 10) voucher at each study visit, for their participation time and any other study-related costs. Baseline clinical characteristics We classified the time of starting cART as prior to conception, during pregnancy or at delivery according to mother self-report or abstracted from the medical records. We abstracted from the medical records the most recent viral load and CD4 count at delivery. Mother’s disclosure of HIV status was classified as yes or no according to mother self-report. Baseline socio-demographic characteristics were obtained by interviewing the mother. Study endpoints Primary endpoints The primary endpoints included exclusive breastfeeding and any form of breastfeeding at week 24. Exclusively breastfeeding was defined as a child who had only breastmilk and no other liquid or solid foods. Any form of breastfeeding was defined as a child who had breastmilk only or breastmilk and other liquid or solid foods. The infant feeding questionnaire was based on the WHO standardized instrument [ 40 ]. Secondary endpoints Infant death or hospitalization for any cause, and non-routine or sick-clinic visits occurring within study duration, were obtained by interviewing the mother. Infant weight and length were measured by the research assistants. Safety outcomes Potential safety events of socially unintended consequences included relationship conflicts with the partner due to study participation, reduced child monitoring due to exaggerated perception of the benefits of breastfeeding (assessed infant immunization history as proxy), and inadvertent disclosure of participant’s HIV status. Statistical methods We summarized baseline characteristics using descriptive statistics. We reported effect sizes with 95% confidence intervals. Statistical significance was set at p < 0.05. Primary analysis of primary endpoints We conducted a complete-case analysis, including participants who completed all study follow-up visits for our primary analyses. A proportion test was used to compare differences in exclusive breastfeeding rates and any form of breastfeeding rates between study groups. Secondary analysis of primary endpoints Binary endpoints We conducted a binomial regression on exclusive breastfeeding and any form of breastfeeding endpoints. Logistic regression was conducted to assess consistency of the effect. Analysis of secondary endpoints Time to event endpoints Analysis of time to stopping any form of breastfeeding and time to first all-cause hospitalization or death outcomes was compared between study groups using the log-rank test. Participants were censored at 24 weeks, or at last completed visit. Binary endpoints We compared the number of child hospitalization or death between study groups using chi-squared test and a logistic regression. Continuous endpoints WHO standardized weight-for-age, length-for-age and weight for-length z-scores were computed adjusting for gestational age at birth, using WHO Anthro Stata macro. We excluded z-scores below − 5 and above 5 from analysis. Mean weight-for-age, length-for-age and weight for-length z-scores were estimated and compared between study groups using random slope linear mixed models. The mixed effects model included study group, time and study group-time interaction as fixed effects and participant and time as random effects. Additional analysis imputing missing outcome data We used multiple imputation to compute missing exclusive breastfeeding and any form of breastfeeding outcome data. We used birthweight, marital status (married versus not married), educational status (primary or no schooling versus secondary or tertiary) as predictor variables. We created 20 imputations using the Stata mi estimate: logit command that combines estimates using the Rubin’s pooling rules. Multiple imputation was done separately by study group. Interim analysis The interim analysis was performed when 103 of the planned modified intention to treat sample size of 184 mother-child pairs completed the study. Of these, only 60 had complete data on the primary outcomes across all visits. The computed z -statistic based on 60 was 0.39, not exceeding the predefined O’Brien-Fleming stopping boundary value of ± 2.7967. Ethics considerations Stellenbosch University Human Research Ethics committee (reference M21/03/010) approved the study. Western Cape Department of Health approved access to Khayelitsha District Hospital (reference WC_202107_007). The DSMB reviewed the unblinded safety data accruing in the study. Results Study recruitment started on 22 July 2022. We screened 1145 mother-infant pairs and recruited 276 mother-infant pairs by 27 November 2023. We randomly assigned 138 mother-infant pairs to each study group. We completed study follow up by 15 May 2024. Figure 1 shows participant flow. One hundred five and 101 participants in the intervention group and standard care group, respectively, had outcome data evaluation across all four study visits. Figure 1. Flow of participants Most mothers were unemployed, had high school education, were single or never married. Disclosure of HIV status to significant others was high, at 95%. Most (87%) mothers had HIV diagnosis before the index pregnancy (Table 1 ). Table 1 Baseline demographic and clinical characteristics of study participants, n = 276 Characteristic Intervention group, n=138 Standard of care group, n=138 Mother age, mean ±SD 32 ±6 years 31 ±6 years Gestational age at booking, mean ±SD 16 ±8 weeks 16 ±8 weeks Gestational age at delivery in weeks, mean ±SD 39± 1 40± 1 Mother most recent CD4 count, median (IQR) 481 (318 to 627) cells/μl 471 (302 to 702) cells/μl Mother most recent viral load, median (IQR) 20 (20 to 44) copies/ml 20 (20 to 26) copies/ml Birthweight, mean ±SD 3218± 416 grams 3207± 383 grams Baby length, mean ±SD 50 ±5 cm 50± 5 cm Occupation, n (%) Unemployed Employed Student Other 87 (63%) 48 (35%) 2 (1%) 1 (1%) 91 (66%) 41 (30%) 4 (3%) 2 (1%) Highest level of schooling, n(%) completed None completed Primary school High school Tertiary 0 (0%) 2 (1%) 131 (95%) 5 (4%) 2 (2%) 3 (2%) 126 (91%) 7 (5%) Marital status, n (%) Single Married/living with partner Divorced/Widowed 79 (57%) 57 (41%) 2 (2%) 82 (59%) 56 (41%) 0 (0%) Baby gender Girl, n (%) 69 (50%) 62 (45%) Number of complete or incomplete pregnancies, n (%) 1 2 3 23 (17%) 113 (82%) 2 (1%) 39 (28%) 97 (70%) 2 (2%) Mode of delivery, n (%) Normal delivery Assisted normal delivery 137 (99%) 1 (1%) 136 (99%) 2 (1%) Time of HIV diagnosis Before pregnancy During pregnancy At delivery 121 (88%) 16 (11%) 1 (1%) 120 (87%) 18 (13%) 0 (0%) Time cART initiation, n (%) Before pregnancy During pregnancy At delivery 123 (89%) 14 (10%) 1 (1%) 118 (85%) 20 (15%) 0 (0%) Disclosure of HIV status to significant others, n (%) No Yes 10 (7%) 128 (93%) 4 (3%) 134 (97%) Baby on antiretroviral prevention, n (%) No Yes Don’t know 130 (94%) 4 (3%) 4 (3%) 131 (95%) 0 (0%) 7 (5%) Infant feeding practices Table 2 Estimate of breastfeeding rates at each study visit by study group. Intervention group: n = 138 Standard care group: n = 138 n Number of endpoints (%) n Number of endpoints (%) Exclusive breastfeeding Visit 1 (week 2) 111 65 (59%) 110 73 (66%) Visit 2 (week 6) 113 67 (59%) 115 59 (51%) Visit 3 (week 10) 121 56 (46%) 119 41 (34%) Visit 4 (week 24) 121 13 (11%) 120 10 (8%) Any form of breastfeeding Visit 1 (week 2) 111 107 (96%) 110 108 (98%) Visit 2 (week 6) 113 105 (93%) 115 110 (96%) Visit 3 (week 10) 121 110 (91%) 119 107 (90%) Visit 4 (week 24) 121 87 (72%) 120 92 (77%) Exclusive breastfeeding practices were modest in both study groups through week 10 and dramatically dropped at week 24 (Table 2 ). We found no significant effect of the intervention on exclusive breastfeeding rates at week 24, (6% versus 7%), rate difference − 1% (95% CI -6–4%). After inputting missing outcome data, we found rate difference of -1% (95% CI -8–5%) (Table 3 ). The z-statistic of -0.36 did not exceed the predefined O’Brien-Fleming stopping boundary value of ± 1.9776. Table 3 Estimate of breastfeeding rates, complete case analysis Intervention group: n = 138 Standard care group: n = 138 n Number of endpoints (%) n Number of endpoints (%) p-value Rate difference (95% CI) Co-primary outcomes Exclusive breastfeeding from childbirth to 24 weeks 105 6 (6%) 101 7 (7%) 0.72 -0.01(-0.06 to 0.04) Any form from breastfeeding from childbirth to 24 weeks 105 79 (75%) 101 79 (78%) 0.61 -0.03 (-0.15 to 0.09) Secondary outcomes Exclusive breastfeeding from childbirth to 6 weeks 105 47 (45%) 105 43 (41%) 0.58 0.04 (-0.10 to 0.17) Any form of breastfeeding from childbirth to 6 weeks 105 98 (93%) 105 96 (91%) 0.60 0.02 (-0.05 to 0.09) Exclusive breastfeeding from childbirth to 10 weeks 105 29 (28%) 102 24 (24%) 0.50 0.04 (-0.08 to 0.16) Any form of breastfeeding from childbirth to 10 weeks 105 97 (92%) 102 91 (89%) 0.43 0.03 (-0.05 to 0.11) All-cause child hospitalization or death 105 4 (2.9%) 9 (6.5%) 0.16 The odds of exclusive breastfeeding at week 24 were 19% non-significantly lower in the intervention group compared to the standard care group, OR 0.81 (95% CI 0.26 to 2.51), p = 0.72. Most mothers continued breastfeeding while adding other foods through week 24 (Table 2 and 3 ). The intervention had no effect on any form of breastfeeding rates (75% versus 78%), rate difference − 3% (95% CI -15–9%) in complete case analysis and after inputting missing outcome data, -3% (95% CI -15–9%) (Table 3 ). The odds of any form of breastfeeding to week 24 were 15% non- significantly lower in the intervention group compared to the standard care group, OR 0.85 (95% CI 0.44 to 1.62), p = 0.61. Sixty-two of 276 (22%) (34 (25%) in the intervention group and 28 (20%) standard care group) mother-child pairs completely stopped breastfeeding before week 24. The median (IQR) age at time of stopping breastfeeding was 16 (6 to 20) weeks. Time to stopping breastfeeding was similar in the study groups, p = 0.37, Fig. 2. The most common reasons reported by mothers for stopping breastfeeding were the mother needing to return to work or look for work, 66% (n = 41) and insufficient breastmilk or child refused breastmilk, 19% (n = 12). Figure 2. Time to stopping any form of breastfeeding, by study group All-cause child hospitalization or death Thirteen children experienced 14 hospital admissions. Twelve children were each hospitalized once, and one child in the intervention group was hospitalized twice. Two hospitalized children died, one from each study group. The number of children hospitalized was not different between the intervention group and standard care group, 4 (2.9%) versus 9 (6.5%), p = 0.16. The intervention reduced the odds of hospitalization or death by 61%, OR 0.39 (95% CI 0.10 to 1.57), p = 0.19. Time to child death or first hospitalization was similar in the groups (Fig. 3), p = 0.18. Early breastfeeding cessation increased risk of child hospitalization or death compared to breastfeeding to 6 months, among children who completed all visits, 10% (5/48) versus 3% (5/158), p = 0.055. Early breastfeeding cessation more than tripled the odds of child hospitalization or death, OR 3.56 (95% CI 0.98 to 12.86). Figure 3. Time to death or first hospitalization, by study group Most children had diarrhea. Incidence of diarrhea decreased over time, rates were 91% at week 2, 86% at week 6, 63% at week 10 and 16% at week 24. Non-routine medically attended visits were similar; 29 in the intervention group and 30 for standard care. Infant growth Infant growth was similar between study groups, (Figs. 4 and Table 4 ). Figure 4. Mean weight for age z-score, weight for length z-score, length for age z-score, by study group Mean weight for age z-scores increased over time in both groups (Fig. 4), with no significant difference between groups, p = 0.87. We found no significant difference in mean length for age z-scores, p = 0.21 and mean weight for length z-scores, p = 0.88. Table 4 Infant growth outcomes, mean z-scores by study group Study visit Intervention Standard care Mean difference (95% CI) Mean weight for age z-score Visit 2 (6 week) 0.26 0.12 0.14 ( -0.13 to 0.40) Visit 3 (10 week) 0.22 0.11 0.11 (-0.16 to 0.38) Visit 4 (24 week) 0.68 0.70 -0.02 ( -0.32 to 0.28) Mean length for age z-score Visit 2 (6 week) -0.89 -0.82 -0.07( -0.49 to 0.36) Visit 3 (10 week) -0.28 -0.57 0.29 ( -0.13 to 0.71) Visit 4 (24 week) 0.49 0.28 0.21 ( -0.22 to 0.63) Mean weight for length z-score Visit 2 (6 week) 1.30 1.20 0.10 ( -0.37 to 0.57) Visit 3 (10 week) 0.78 0.77 0.01 ( -0.45 to 0.48) Visit 4 (24 week) 0.76 0.82 -0.06 ( -0.54 to 0.41) Safety outcomes Most mothers reported cART adherence in the month prior to each visit as very good or excellent across all visits, rates of very good or excellent adherence ranged between 90% and 97%. Study participation led to no involuntary disclosure of HIV status. No mother reported relationship conflicts with their partners due to study participation. Child immunization profiles were similar across study groups, all infants received BCG at birth, 99% received the week 6, 10 and 14 immunizations and only 19% had received the six-month immunizations. Discussion Our primary objective was to demonstrate superiority of the intervention on sustaining exclusive breastfeeding to week 24 among mothers living with HIV in Western Cape Province, South Africa. However, we found no effect of motivational interviewing and text messaging compared to standard infant feeding counselling on exclusive breastfeeding or any form of breastfeeding rates at week 24. We however, found a marginal increase on exclusive breastfeeding rates in the intervention group through week 10, declining precipitously by week 24. The modest exclusive breastfeeding rates in early infancy within the standard infant feeding counselling group exceeded the 8% rate we initially expected. Our findings support a study reporting an increase in 4 to 8 weeks exclusive breastfeeding rates, coinciding with the Tshwane Declaration of support for breastfeeding [ 41 ]. Similarly, a cohort study found that South African mothers living with HIV breastfed exclusively in the first three weeks with a significant drop four months later [ 28 ]. By 12 months of age, approximately 40% of children born to mothers living with HIV in South Africa are breastfed [ 13 ]. Exclusive breastfeeding rates are far below the global target of 50% at six months. Most mothers introduced other foods before six months while breastfeeding. A comparison between the findings of our cohort study 12 years ago and our current trial demonstrate an improvement from 50% breastfeeding cessation rate [ 42 ] to 22% in 2024. Additionally, there has been a marked increase in any form of breastfeeding practice over the past decade. The increase may be attributed to efforts at national and provincial levels to promote exclusive breastfeeding among mothers living with HIV, following adoption of the breastfeeding policy. However, early breastfeeding cessation remains a public health threat. Work-related demands influenced mothers’ decision to stop breastfeeding. Various studies have shown that motivational interviewing and text messaging enhanced HIV viral load suppression, promoted weight loss, reduced alcohol and tobacco use and improved cART adherence [ 30 ][ 31 ] [ 32 ] [ 33 ]; the intervention positively impacted health conditions unlikely to interfere with the individual’s social or work-related demands. The combined intervention might not have met the socio-economic needs of the predominantly unemployed mothers. Our trial suggests that interventions focusing solely on the mother, without considering her socio-economic conditions will not improve exclusive breastfeeding rates. Maternal employment and schooling demands are key barriers to breastfeeding among mothers living with HIV [ 43 ]. Infant feeding occurs within a broader context of family, socio-cultural, economic, and health care system. Innovative interventions responsive to socio-economic challenges faced by mothers of reproductive and working age may be more effective in achieving the global target of 50% exclusive breastfeeding rates. The common practice of any form of breastfeeding among mothers with high cART adherence contributed to low incidence of child hospitalization or death from any cause. The increased risk of child hospitalization or death among those who stopped breastfeeding emphasizes the benefits of any form of breastfeeding. This is consistent with other studies reporting an association between breastfeeding and infection-related hospitalization[ 13 ]. The findings affirm the WHO guiding practice statement “practicing mixed feeding is not a reason to stop breastfeeding in the presence of cART”[ 1 ]. Most mothers acquired HIV infection before pregnancy and had low HIV viral loads. Child hospitalization or death profiles are likely worse where mothers present with incident HIV infection, high viral load or poor cART adherence. While finding interventions to enhance exclusive breastfeeding remains critical, HIV services should reliably offer cART, consistently monitor viral load, and support mothers cART adherence, especially where mixed feeding is common. Mothers who stopped breastfeeding did not consider expressing breastmilk as an alternative to continue breastfeeding. There are opportunities during routine infant feeding counselling to educate mothers about social or work demands that may arise during breastfeeding and potential solutions to enable breastfeeding even during these challenges. Our trial had limitations. Our findings cannot be generalized to settings where mothers are employed with a stable source of income. Conclusion Socio-economic pressures influenced mothers’ decision to stop breastfeeding. Introduction of other foods before six months while breastfeeding remains common. Early cessation of breastfeeding is a public health threat. Finding interventions to enhance exclusive breastfeeding and the provision of high-quality HIV services remains critical. Innovative interventions responsive to socio-economic challenges faced by mothers may be more effective in improving exclusive breastfeeding rates. Trial status Protocol version number 1 31 May 2021, recruitment began on 22 July 2023, and trial follow up was completed on 15 May 2024. Abbreviations cART: combination antiretroviral treatment; WHO: World Health Organization; DSMB: Data Safety Monitoring Board; EDCTP: European & Developing Countries Clinical Trials Partnership; HEU: HIV exposed uninfected; HIV: Human immunodeficiency virus; PI: principal investigator; RALLOC: random number generating command; REDCap: Research Electronic Data Capture; CONSORT: Consolidated Standards of Reporting Trials, Declarations Funding statement This project has received funding from the EDCTP2 programme (TMA2020CDF-3169-MTM-MI), supported by the European Union and the Fondation Botnar, South Africa Medical Research Council, Self-Initiated Research Grant, Stellenbosch University Subcommittee C, Stellenbosch University Early-Career Research Funding, Stellenbosch University temporary research assistance funding. The funders had no role in study design, data collection, data analysis, interpretation, preparation of the manuscript, or decision to publish. Conflict of interest disclosure The authors declare that they have no competing interests. Ethics approval statement Stellenbosch University Human Research Ethics committee (reference M21/03/010) approved the study. Western Cape Department of Health approved access to Khayelitsha District Hospital for study recruitment (reference WC_202107_007). Mothers signed a written informed consent form for their and their child’s participation in this study. Patient consent statement Not applicable. Study results are presented in aggregate format in technical reports and journal publications. A model consent form is provided on request. Permission to reproduce material from other sources Not applicable. Clinical trial registration The trial was registered on ClinicalTrials.gov (NCT05063240) and Pan African Clinical Trial Registries (PACTR202110870407786) before recruitment of the first subject. References World Health Organization, United Nations Children’s Fund. Guideline: updates on HIV and infant feeding: the duration of breastfeeding, and support from health services to improve feeding practices among mothers living with HIV. Geneva: World Health Organ. 2016. Rollins N, Bhandari N, Hajeebhoy N. Why invest, and what it will take to improve breastfeeding practices? Lancet. 2016;387(10017):491–504. Sankar MJ, Sinha B, Chowdhury R, Bhandari N, Taneja S, Martines J, et al. Optimal breastfeeding practices and infant and child mortality: A systematic review and meta-analysis. Vol. 104, Acta Paediatrica, International Journal of Paediatrics. 2015. Sinha B, Chowdhury R, Upadhyay RP, Taneja S, Martines J, Bahl R, et al. Integrated interventions delivered in health systems, home, and community have the highest impact on breastfeeding outcomes in low- and middle-income countries. Journal of Nutrition. 2017;147(11). Victora CG, Bahl R, Barros AJD, França GVA, Horton S, Krasevec J, et al. Breastfeeding in the 21st century: Epidemiology, mechanisms, and lifelong effect. Vol. 387, The Lancet. 2016. Myer L, Phillips T. Beyond ‘Option B+.’ JAIDS. 2017;75(Suppl 2):S115–S122. Flynn PM, Taha TE, Cababasay M, Fowler MG, Mofenson LM, Owor M, et al. Prevention of HIV-1 transmission through breastfeeding: Efficacy and safety of maternal antiretroviral therapy versus infant nevirapine prophylaxis for duration of breastfeeding in HIV-1-infected women with high cd4 cell count (IMPAACT PROMISE): A randomized, open-label, clinical trial. J Acquir Immune Defic Syndr (1988). 2018;77(4). Nor B, Ahlberg BM, Doherty T, Zembe Y, Jackson D, Ekström EC. Mother’s perceptions and experiences of infant feeding within a community-based peer counselling intervention in South Africa. Matern Child Nutr. 2012;8(4). Kedir M, Mengistu YG. Assessment of Infant Feeding Practice Among HIV Positive Mothers and HIV Status of Their Infants in Adama Hospital, Oromia Regional State, Ethiopia, 2016. J Pregnancy Child Health. 2017;04(05). Aishat U, David D, Olufunmilayo F. Exclusive breastfeeding and HIV/AIDS: A crossectional survey of mothers attending prevention of mother-to-child transmission of HIV clinics in southwestern Nigeria. Pan African Medical Journal. 2015;21. Davis NL, Miller WC, Hudgens MG, Chasela CS, Sichali D, Kayira D, et al. Maternal and breastmilk viral load: Impacts of adherence on peripartum HIV infections averted - The breastfeeding, antiretrovirals, and nutrition study. J Acquir Immune Defic Syndr (1988). 2016;73(5). MS K, R K. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2012;8:CD003517. le Roux S, Abrams E, Donald K, Brittain K, Phillips T, Zerbe A, et al. Infectious morbidity of breastfed, HIV-exposed uninfected infants under conditions of universal antiretroviral therapy in South Africa: a prospective cohort study. Lancet Child Adolesc Health. 2020;4(3). Tylleskär T, Jackson D, Meda N, Engebretsen IMS, Chopra M, Diallo AH, et al. Exclusive breastfeeding promotion by peer counsellors in sub-Saharan Africa (PROMISE-EBF): A cluster-randomised trial. The Lancet. 2011;378(9789). Issaka AI, Agho KE, Renzaho AMN. Prevalence of key breastfeeding indicators in 29 sub-Saharan African countries: A meta-analysis of demographic and health surveys (2010-2015). BMJ Open. 2017;7(10). World Health Organization. https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding. 2023. Infant and young child feeding. Doherty T, Sanders D, Jackson D, Swanevelder S, Lombard C, Zembe W, et al. Early cessation of breastfeeding amongst women in South Africa: an area needing urgent attention to improve child health. BMC Pediatr. 2012;12. National Department of Health, Statistics South Africa, South African Medical Research Council, ICF. South Africa demographic and health survey 2016: Key indicators. Pretoria, South Africa and Rockville, Maryland, USA: NDoH, Stats SA, SAMRC, and ICF,. 2017. Samburu BM, Young SL, Wekesah FM, Wanjohi MN, Kimiywe J, Muriuki P, et al. Effectiveness of the baby-friendly community initiative in promoting exclusive breastfeeding among HIV negative and positive mothers: A randomized controlled trial in Koibatek Sub-County, Baringo, Kenya. Int Breastfeed J. 2020;15(1). Njom Nlend AE, Motaze ACN, Sandie A, Fokam J. HIV-1 transmission and survival according to feeding options in infants born to HIV-infected women in Yaoundé, Cameroon. BMC Pediatr. 2018;18(1). Chaponda A, Goon DT, Hoque ME. Infant feeding practices among HIV-positive mothers at Tembisa hospital, South Africa. Afr J Prim Health Care Fam Med. 2017;9(1). Humphrey J. The risks of not breastfeeding. J Acquir Immune Defic Syndr. 2010;53(1):1–4. Kimani-Murage EW, Wekesah F, Wanjohi M, Kyobutungi C, Ezeh AC, Musoke RN, et al. Factors affecting actualisation of the WHO breastfeeding recommendations in urban poor settings in Kenya. Matern Child Nutr. 2015;11(3). Nyoni S, Sweet L, Clark J, Ward P. A realist review of infant feeding counselling to increase exclusive breastfeeding by HIV-positive women in sub Saharan-Africa: What works for whom and in what contexts. BMC Public Health. 2019;19(1). Statistics South Africa. Statistics South Africa. Mid-year population estimates 2017. https://www.statssa.gov.za/publications/P0302/P03022017.pdf.; 2017. Kharsany ABM, Frohlich JA, Yende-Zuma N, Mahlase G, Samsunder N, Dellar RC, et al. Trends in HIV prevalence in pregnant women in rural South Africa. J Acquir Immune Defic Syndr (1988). 2015;70(3). Department of Health. The Tshwane Declaration of Support for Breastfeeding in South Africa. South African Journal of Clinical Nutrition. 2011;24(4). Goga AE, Doherty T, Jackson DJ, Sanders D, Colvin M, Chopra M, et al. Infant feeding practices at routine PMTCT sites, South Africa: Results of a prospective observational study amongst HIV exposed and unexposed infants - birth to 9 months. Int Breastfeed J. 2012;7. Jones DL, Rodriguez VJ, Mandell LN, Lee TK, Weiss SM, Peltzer K. Influences on Exclusive Breastfeeding Among Rural HIV-Infected South African Women: A Cluster Randomized Control Trial. AIDS Behav. 2018;22(9). Iribarren S, Beck S, Pearce P, Chirico C, Etchevarria, M Cardinale D, Rubinstein F. TextTB: A mixed method pilot study evaluating acceptance, feasibility, and exploring initial efficacy of a text messaging intervention to support TB treatment adherence. Tuberc Res Treat. 2013;2013. Dick J, Nundy S, Solomon M, Bishop K, Chin M, Peek M. Feasibility and usability of a text message-based program for diabetes self-management in an urban African-American population. J Diabetes Sci Technol. 2011;5(5):1246–54. Pop-Eleches, C Thirumurthy, H Habyarimana J, Zivin J, Goldstein M, de Walque D, MacKeen L, Haberer J, et al. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011;25(6):825–34. Miller W, Rollnick S. Motivational interviewing: preparing people to change behaviour. New York: Guilford Press; 1991. Chinkonde JR, Hem MH, Sundby J. HIV and infant feeding in Malawi: Public health simplicity in complex social and cultural contexts. BMC Public Health. 2012;12(1). Odeny BM, Pfeiffer J, Farquhar C, Igonya EK, Gatuguta A, Kagwaini F, et al. The Stigma of Exclusive Breastfeeding among Both HIV-Positive and HIV-Negative Women in Nairobi, Kenya. Breastfeeding Medicine. 2016;11(5). Hazemba AN, Ncama BP, Sithole SL. Promotion of exclusive breastfeeding among HIV-positive mothers: An exploratory qualitative study. Int Breastfeed J. 2016;11(1). Ijumba P, Doherty T, Jackson D, Tomlinson M, Sanders D, Persson LÅ. Free formula milk in the prevention of mother-to-child transmission programme: Voices of a peri-urban community in South Africa on policy change. Health Policy Plan. 2013;28(7). Zunza M, Thabane L, Kuhn L, Els C, Cotton MF, Young T. Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI). Trials. 2023;24(1). Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. BMJ (Online). 2010;340(7748). World Health Organization. Breastfeeding and replacement feeding practices in the context of mother-to-child transmission of HIV: an assessment tool for research and programs. Geneva: WHO. 2001. Jackson D, Swanevelder S, Doherty T, Lombard C, Bhardwaj S, Goga A. Changes in rates of early exclusive breastfeeding in South Africa from 201 to 2013: data from three national surveys before and during implementation of a change in national breastfeeding policy. BMJ Open. 2019;9(11). Zunza M, Esser M, Slogrove A, Bettinger JA, Machekano R, Cotton MF. Early Breastfeeding Cessation Among HIV‑Infected and HIV‑Uninfected Women in Western Cape Province, South Africa. AIDS Behav. 2018;22:S114–S120. Nabulsi M. Why are breastfeeding rates low in Lebanon? a qualitative study. BMC Pediatr. 2011;11. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 20 Jan, 2025 Read the published version in International Breastfeeding Journal → Version 1 posted Editorial decision: Revision requested 07 Nov, 2024 Reviews received at journal 04 Nov, 2024 Reviews received at journal 22 Oct, 2024 Reviews received at journal 21 Oct, 2024 Reviewers agreed at journal 30 Sep, 2024 Reviewers agreed at journal 30 Sep, 2024 Reviewers agreed at journal 29 Sep, 2024 Reviewers invited by journal 28 Sep, 2024 Editor assigned by journal 27 Sep, 2024 Submission checks completed at journal 27 Sep, 2024 First submitted to journal 22 Sep, 2024 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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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-5132328","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":375526215,"identity":"f113d30b-74e5-4a48-9802-d5d4aa6983e5","order_by":0,"name":"Moleen Zunza","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAwElEQVRIiWNgGAWjYFAC5gYQKUeKFkawFmPStSQ2EK1Bt72x8cHHHXXp82fkHmD4UcNgz09Is9mZg82GM8+w5W64kZfA2HOMgVniACEtNxLbpHnbeHI3SOQYMPA2MLAxEKGl/fffNol0+Rk5Box/Gxh45ImxhZmxzSCB4UaOATPQFgkDglqAfpHsbUsw3HDmjcFhmWMSBoYEtRxvPvjhZ1udvHx7juHDNzU29nKEtKAAoGIJUtSPglEwCkbBKMAFAJR0PnVX69NdAAAAAElFTkSuQmCC","orcid":"","institution":"Division of Epidemiology \u0026 Biostatistics, Stellenbosch University","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Moleen","middleName":"","lastName":"Zunza","suffix":""},{"id":375526217,"identity":"9f623c6a-2137-490a-a3ef-dca8c2236205","order_by":1,"name":"Lehana Thabane","email":"","orcid":"","institution":"Department of Biostatistics Health Research Methods, Evidence, and Impact, McMaster University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Lehana","middleName":"","lastName":"Thabane","suffix":""},{"id":375526218,"identity":"e60497b5-6c7b-43b5-a5b3-13a40ba5017e","order_by":2,"name":"Louise Kuhn","email":"","orcid":"","institution":"Gertude H. Sergievsky Center, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Louise","middleName":"","lastName":"Kuhn","suffix":""},{"id":375526219,"identity":"51ffc3d2-d93b-4fc0-b3b9-9914e93e1176","order_by":3,"name":"Christine Els","email":"","orcid":"","institution":"Khayelitsha District Hospital, Western Cape Department of Health","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Christine","middleName":"","lastName":"Els","suffix":""},{"id":375526220,"identity":"132b2dc0-ec23-436d-b645-48e1dff8c2a3","order_by":4,"name":"Carl Lombard","email":"","orcid":"","institution":"Division of Epidemiology \u0026 Biostatistics, Stellenbosch University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Carl","middleName":"","lastName":"Lombard","suffix":""},{"id":375526221,"identity":"4f7a6034-4b01-4499-9be1-605b9d7b5cc0","order_by":5,"name":"Mark F. Cotton","email":"","orcid":"","institution":"Department of Paediatrics and Child Health, Family Center for Research with Ubuntu, Stellenbosch University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Mark","middleName":"F.","lastName":"Cotton","suffix":""},{"id":375526222,"identity":"88352af8-db06-47fd-bca5-5845de4cf565","order_by":6,"name":"Taryn Young","email":"","orcid":"","institution":"Division of Epidemiology \u0026 Biostatistics, Stellenbosch University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Taryn","middleName":"","lastName":"Young","suffix":""}],"badges":[],"createdAt":"2024-09-22 12:06:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5132328/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5132328/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13006-024-00693-2","type":"published","date":"2025-01-20T15:57:45+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":69850594,"identity":"03e4f62c-e3ed-47dd-aa2c-8106a09e8192","added_by":"auto","created_at":"2024-11-25 23:28:23","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":672281,"visible":true,"origin":"","legend":"\u003cp\u003eFlow of participants\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-5132328/v1/37c49cbd69c1e8e831a72195.png"},{"id":69850590,"identity":"f1193e6f-271d-48a5-b8e1-efd46614c8e0","added_by":"auto","created_at":"2024-11-25 23:28:23","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":162504,"visible":true,"origin":"","legend":"\u003cp\u003eTime to stopping any form of breastfeeding, by study group\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-5132328/v1/1204c7cbf63067c3705758f0.png"},{"id":69850591,"identity":"fa53d564-1b37-44ab-a7a1-37db834eaf20","added_by":"auto","created_at":"2024-11-25 23:28:23","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":161978,"visible":true,"origin":"","legend":"\u003cp\u003eTime to death or first hospitalization, by study group\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-5132328/v1/b46c03c7b3be284591f732f0.png"},{"id":69850861,"identity":"864a46d3-6315-4ee0-ae38-39ee0b8efa6b","added_by":"auto","created_at":"2024-11-25 23:36:23","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":229348,"visible":true,"origin":"","legend":"\u003cp\u003eMean weight for age z-score, weight for length z-score, length for age z-score, by study group\u003c/p\u003e","description":"","filename":"floatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-5132328/v1/1256d9070c7c9ee2b6793bde.png"},{"id":74859152,"identity":"e0cc3e7d-ffff-406b-80ff-6e23958c8ea2","added_by":"auto","created_at":"2025-01-27 16:13:41","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2395898,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5132328/v1/0e3cc952-08c9-4a9d-984e-9f88f2e58f32.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"A randomized controlled, trial on effects of mobile phone text messaging in combination with motivational interviewing versus standard infant feeding counselling on breastfeeding and child health outcomes, among women living with HIV","fulltext":[{"header":"Introduction","content":"\u003cp\u003eBreastfeeding improves a child’s health, development and survival, offering significant social and economic benefits, particularly where diarrhoea, pneumonia and undernutrition are leading causes of death in children under five[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Exclusive breastfeeding could prevent 13% of under-five deaths annually in low- and middle-income settings[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. The World Health Organization (WHO) recommends exclusive breastfeeding for the first six months of life, followed by continued breastfeeding with appropriate complementary foods for two years or longer[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Optimal treatment with combination antiretroviral treatment (cART) has reduced the risk of mother-to-child transmission (MTCT) of HIV rates below 2% [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Adherence to cART and breastfeeding exclusively [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] can reduce postpartum vertical transmission of HIV and lower under-five all-cause death [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e][\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e][\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. In contrast, mixed feeding is associated with increased risk of vertical transmission of HIV and higher under-five death and morbidity if mothers are not on cART [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite awareness of exclusive breastfeeding benefits and efforts to promote optimal infant feeding, the practice of exclusive breastfeeding is low in sub-Saharan Africa[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e][\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. In sub-Saharan Africa, only 37% of infants under 6 months are exclusively breastfed [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Exclusive breastfeeding rates are below 50%, the global target[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Exclusive breastfeeding among South African mothers improved in recent years, but remains below global targets, with 32% of infants exclusively breastfed for the first six months [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], however, regional disparities in breastfeeding practices remains. Early breastfeeding cessation and mixed feeding before six months of age are common practices [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. The 2016 South Africa Demographic and Health survey found that among children aged 0–5 months, 25.2% were never breastfed, 11.4% were receiving breastmilk and other milk, and 17.6% received complementary feeds [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Approximately, 40% of mothers living with HIV in South Africa stop breastfeeding before 12 weeks [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. In Kenya, approximately 59% of HIV-exposed infants under 6 months are exclusively breastfed, and only 32% are breastfed up to one year [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Sub-optimal feeding practices are associated with vertical transmission of HIV[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Mothers living with HIV fear transmitting HIV to infants leading to sub-optimal infant feeding practices[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e][\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. For the same reason, some healthcare providers, discourage breastfeeding [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSouth Africa is one of the countries with the highest burden of HIV [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Due to high prevalence of HIV pregnancy (30.8%)[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e], the South African Government prioritized elimination of vertical HIV transmission [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Prior to 2011, South African infant feeding policy recommended exclusive formula feeding [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. All public healthcare facilities provided free infant formula to mothers living with HIV until 6 months of age [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. In October 2012, South Africa adopted the WHO 2010 guidelines, promoting exclusive breastfeeding only [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite the counselling on infant-feeding offered at primary healthcare facilities and many interventions to promote optimal infant feeding, practices remain suboptimal [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e][\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Studies showed that infant feeding counselling improves infant feeding practices in South Africa [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Mobile phone text messaging, a simple, low-cost intervention, improves medication adherence among patients with HIV, diabetes, and tuberculosis[\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e][\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. Motivational interviewing, a patient-centred non-coercive approach [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e], is beneficial across many health problems, including HIV viral load suppression, weight loss, and alcohol and tobacco use, and medication adherence among patients with HIV and tuberculosis. There are different factors at multiple levels preventing mothers from following recommended infant feeding practices, leading to early breastfeeding cessation or mixed feeding during the first 6 months, particularly in low- and middle-income countries[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Infant feeding cultural norms, stigma, inadequate counselling and limited financial resources, and infant feeding knowledge are among the factors influencing infant feeding choices of mothers living with HIV [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e][\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e][\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. In South Africa, the shift from exclusively using formula feeding and provision of free formula milk to promoting exclusive breastfeeding resulted in healthcare provides often giving insufficient or contradictory advice [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. While some mothers follow healthcare providers’ advice on infant feeding, others find it challenging due to individual circumstances [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e][\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e][\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSignificant gaps still exist in developing innovative strategies to support breastfeeding in environments with low exclusive breastfeeding rates. The trial objective was to demonstrate the superiority of mobile phone text messaging in combination with motivational interviewing over standard infant feeding counselling in increasing week 24 exclusive- and any form of -breastfeeding rates, reducing risk of child hospitalization or death and improving linear growth.\u003c/p\u003e\n\n\n\n\n\n\n\n \n\n\n\n \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003cdiv id=\"Sec18\" class=\"Section3\"\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003cdiv id=\"Sec20\" class=\"Section3\"\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Study methods and design","content":"\u003ch2\u003eTrial design\u003c/h2\u003e\u003cp\u003eWe previously described the study methods [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]. Briefly, we conducted a parallel group, standard care-controlled randomized trial evaluating infant feeding practices at four follow up visits, among 276 mother-child pairs. We randomly assigned participants to either weekly mobile phone text messaging plus in-person motivational interviewing or to standard infant counselling for 24 weeks. The principal investigator used Stata 17 random number generating command (RALLOC), to generate the randomization allocation sequence restricted by permuted block sizes of 2, 4 and 6, with a 1:1 allocation ratio. A research assistant enrolled study participants, collected baseline data using the Research Electronic Data Capture (REDCap) mobile application and uploaded the data to the REDCap online server. The principal investigator assigned study group sequentially, using the locked unmodifiable allocation sequence stored on the REDCap online server.\u003c/p\u003e\u003cp\u003eA research assistant not administering the study interventions completed outcome evaluation questionnaires at follow up visits, without knowledge of group assignment. A different research assistant administered the study interventions. An independent data analyst performed unblinded interim analysis during trial monitoring. Study participants and the principal investigator were aware of the group assignment. This manuscript was written following the Consolidated Standards of Reporting Trials (CONSORT 2010) guidelines for reporting parallel group randomized trial [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e].\u003c/p\u003e\u003ch3\u003eSetting and study population\u003c/h3\u003e\u003cp\u003eMothers were counselled to exclusively breastfeed for the first 6 months by nurses and trained lay counsellors during routine postnatal clinic visits at their local primary healthcare clinics. Khayelitsha District Hospital provides secondary-level healthcare services. Women were invited to participate within 24 hours of giving birth at Khayelitsha District Hospital and followed for 6 months at Masiphuhlisane Research Centre in Khayelitsha, Cape Town. We enrolled mothers living with HIV, initiating breastfeeding, on cART, 18 years or older, with a mobile phone, and their infants. We excluded mothers who initiated formula feeding within 24 hours of giving birth, gave birth to more than one infant, infant birthweight \u0026lt; 2500 grams or gestational age at birth \u0026lt; 36 weeks.\u003c/p\u003e\u003ch3\u003eStudy interventions\u003c/h3\u003e\u003ch2\u003eMobile phone text messaging and motivational interviewing\u003c/h2\u003e\u003cp\u003eA research assistant sent text message weekly to mothers in the intervention group, encouraging exclusive breastfeeding and inquired if there were any breastfeeding problems. The research assistant contacted mothers who indicated a breastfeeding problem and those who failed to respond within 48 hours. Mothers with breastfeeding problems were advised to seek healthcare services at their primary healthcare facilities. Mothers had individual motivational interviews post-delivery at week 2, 6, and 10. During the interviews, the research assistant and the mother discussed breastfeeding practices and problems, potential solutions, reinforced mother’s own self-motivational statements and readiness to correct suboptimal infant feeding practices and affirm the mother’s freedom of choice. Text messaging and motivational interviews were discontinued for mothers who completely stopped breastfeeding before trial conclusion. The mother-child pair who stopped breastfeeding early were followed for the secondary outcomes.\u003c/p\u003e\u003ch3\u003eStandard care infant feeding counselling\u003c/h3\u003e\u003cp\u003eParticipants in the standard care infant feeding counselling group were counselled by primary healthcare nurses and trained lay counsellors to exclusively breastfeed for the first six months as part of routine healthcare practice.\u003c/p\u003e\u003ch2\u003eSample size, power, and detectable differences\u003c/h2\u003e\u003cp\u003eWe expected exclusive breastfeeding rate of 8% at age 6 month in the standard care group[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. To detect a difference of 15% between the intervention and standard care groups (i.e., 23% vs 8%), 182 mother-infant pairs were required for a two-sided test traditional fixed sample size computation. Adjusting the sample size for two planned analyses using the O’Brien-Fleming inflation factor 1.01 at the 0.05 significance level and 80% power, we revised the sample size to 182 × 1.01 = 184 and further inflated the sample size by 33% to 275 mother -infant pairs, accounting for loss to follow up.\u003c/p\u003e\u003ch3\u003eStudy measurements and procedures\u003c/h3\u003e\u003cp\u003eThe study included an enrolment maternal interview at Khayelitsha District hospital, four in-person follow-up visits at week 2, 6, 10, and 24, at Masiphuhlisane Research Centre, child medical record review, and child length and weight measurements. Baseline sociodemographic and clinical characteristics were obtained by interviewing the mother and abstracting medical records data. At each visit, a research assistant interviewed the mother using a questionnaire of food items given to the child in the last week or 24 hours preceding the inquiry. Infant death, hospitalization, safety events and other study related data were obtained by interviewing the mother. The study provided transport to and from the study follow up research site; mothers received a R180 (~ US \u003cspan\u003e$\u003c/span\u003e10) voucher at each study visit, for their participation time and any other study-related costs.\u003c/p\u003e\u003ch3\u003eBaseline clinical characteristics\u003c/h3\u003e\u003cp\u003eWe classified the time of starting cART as prior to conception, during pregnancy or at delivery according to mother self-report or abstracted from the medical records. We abstracted from the medical records the most recent viral load and CD4 count at delivery. Mother’s disclosure of HIV status was classified as yes or no according to mother self-report. Baseline socio-demographic characteristics were obtained by interviewing the mother.\u003c/p\u003e\u003ch2\u003eStudy endpoints\u003c/h2\u003e\u003ch2\u003ePrimary endpoints\u003c/h2\u003e\u003cp\u003eThe primary endpoints included exclusive breastfeeding and any form of breastfeeding at week 24. Exclusively breastfeeding was defined as a child who had only breastmilk and no other liquid or solid foods. Any form of breastfeeding was defined as a child who had breastmilk only or breastmilk and other liquid or solid foods. The infant feeding questionnaire was based on the WHO standardized instrument [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e].\u003c/p\u003e\u003ch2\u003eSecondary endpoints\u003c/h2\u003e\u003cp\u003eInfant death or hospitalization for any cause, and non-routine or sick-clinic visits occurring within study duration, were obtained by interviewing the mother. Infant weight and length were measured by the research assistants.\u003c/p\u003e\u003ch2\u003eSafety outcomes\u003c/h2\u003e\u003cp\u003ePotential safety events of socially unintended consequences included relationship conflicts with the partner due to study participation, reduced child monitoring due to exaggerated perception of the benefits of breastfeeding (assessed infant immunization history as proxy), and inadvertent disclosure of participant’s HIV status.\u003c/p\u003e\u003ch2\u003eStatistical methods\u003c/h2\u003e\u003cp\u003eWe summarized baseline characteristics using descriptive statistics. We reported effect sizes with 95% confidence intervals. Statistical significance was set at \u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05.\u003c/p\u003e\u003ch2\u003ePrimary analysis of primary endpoints\u003c/h2\u003e\u003cp\u003eWe conducted a complete-case analysis, including participants who completed all study follow-up visits for our primary analyses. A proportion test was used to compare differences in exclusive breastfeeding rates and any form of breastfeeding rates between study groups.\u003c/p\u003e\u003ch2\u003eSecondary analysis of primary endpoints\u003c/h2\u003e\u003ch2\u003eBinary endpoints\u003c/h2\u003e\u003cp\u003eWe conducted a binomial regression on exclusive breastfeeding and any form of breastfeeding endpoints. Logistic regression was conducted to assess consistency of the effect.\u003c/p\u003e\u003ch2\u003eAnalysis of secondary endpoints\u003c/h2\u003e\u003ch2\u003eTime to event endpoints\u003c/h2\u003e\u003cp\u003eAnalysis of time to stopping any form of breastfeeding and time to first all-cause hospitalization or death outcomes was compared between study groups using the log-rank test. Participants were censored at 24 weeks, or at last completed visit.\u003c/p\u003e\u003ch2\u003eBinary endpoints\u003c/h2\u003e\u003cp\u003eWe compared the number of child hospitalization or death between study groups using chi-squared test and a logistic regression.\u003c/p\u003e\u003ch2\u003eContinuous endpoints\u003c/h2\u003e\u003cp\u003eWHO standardized weight-for-age, length-for-age and weight for-length z-scores were computed adjusting for gestational age at birth, using WHO Anthro Stata macro. We excluded z-scores below − 5 and above 5 from analysis. Mean weight-for-age, length-for-age and weight for-length z-scores were estimated and compared between study groups using random slope linear mixed models. The mixed effects model included study group, time and study group-time interaction as fixed effects and participant and time as random effects.\u003c/p\u003e\u003ch2\u003eAdditional analysis imputing missing outcome data\u003c/h2\u003e\u003cp\u003eWe used multiple imputation to compute missing exclusive breastfeeding and any form of breastfeeding outcome data. We used birthweight, marital status (married versus not married), educational status (primary or no schooling versus secondary or tertiary) as predictor variables. We created 20 imputations using the Stata mi estimate: logit command that combines estimates using the Rubin’s pooling rules. Multiple imputation was done separately by study group.\u003c/p\u003e\u003ch2\u003eInterim analysis\u003c/h2\u003e\u003cp\u003eThe interim analysis was performed when 103 of the planned modified intention to treat sample size of 184 mother-child pairs completed the study. Of these, only 60 had complete data on the primary outcomes across all visits. The computed \u003cem\u003ez\u003c/em\u003e-statistic based on 60 was 0.39, not exceeding the predefined O’Brien-Fleming stopping boundary value of ± 2.7967.\u003c/p\u003e\u003ch2\u003eEthics considerations\u003c/h2\u003e\u003cp\u003eStellenbosch University Human Research Ethics committee (reference M21/03/010) approved the study. Western Cape Department of Health approved access to Khayelitsha District Hospital (reference WC_202107_007). The DSMB reviewed the unblinded safety data accruing in the study.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eStudy recruitment started on 22 July 2022. We screened 1145 mother-infant pairs and recruited 276 mother-infant pairs by 27 November 2023. We randomly assigned 138 mother-infant pairs to each study group. We completed study follow up by 15 May 2024. Figure\u0026nbsp;1 shows participant flow. One hundred five and 101 participants in the intervention group and standard care group, respectively, had outcome data evaluation across all four study visits.\u003c/p\u003e\n\u003cp\u003eFigure 1. Flow of participants\u003c/p\u003e\n\u003cp\u003eMost mothers were unemployed, had high school education, were single or never married. Disclosure of HIV status to significant others was high, at 95%. Most (87%) mothers had HIV diagnosis before the index pregnancy (Table \u003cspan\u003e1\u003c/span\u003e).\u003c/p\u003e\n\u003cdiv\u003eTable 1 Baseline demographic and clinical characteristics of study participants, \u003cem\u003en\u003c/em\u003e = 276\u003c/div\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"567\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eCharacteristic\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003eIntervention group, n=138\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003eStandard of care group, n=138\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: 39.8589%;\"\u003e\n \u003cp\u003eMother age, mean \u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e32 \u0026plusmn;6 years\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e31 \u0026plusmn;6 years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eGestational age at booking, mean \u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e16 \u0026plusmn;8 weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e16 \u0026plusmn;8 weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eGestational age at delivery in weeks, mean \u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e39\u0026plusmn; 1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e40\u0026plusmn; 1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eMother most recent CD4 count, median (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e481 (318 to 627) cells/\u0026mu;l\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e471 (302 to 702) cells/\u0026mu;l\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eMother most recent viral load, median (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e20 (20 to 44) copies/ml\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e20 (20 to 26) copies/ml\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eBirthweight, mean \u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e3218\u0026plusmn; 416 grams\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e3207\u0026plusmn; 383 grams\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eBaby length, mean \u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e50 \u0026plusmn;5 cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e50\u0026plusmn; 5 cm\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eOccupation, n (%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; Unemployed\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; Employed\u003c/p\u003e\n \u003cp\u003eStudent\u003c/p\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e87 (63%)\u003c/p\u003e\n \u003cp\u003e48 (35%)\u003c/p\u003e\n \u003cp\u003e2 (1%)\u003c/p\u003e\n \u003cp\u003e1 (1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e91 (66%)\u003c/p\u003e\n \u003cp\u003e41 (30%)\u003c/p\u003e\n \u003cp\u003e4 (3%)\u003c/p\u003e\n \u003cp\u003e2 (1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eHighest level of schooling, n(%) \u0026nbsp;completed\u003c/p\u003e\n \u003cp\u003eNone completed\u003c/p\u003e\n \u003cp\u003ePrimary school\u003c/p\u003e\n \u003cp\u003eHigh school\u003c/p\u003e\n \u003cp\u003eTertiary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003cp\u003e2 (1%)\u003c/p\u003e\n \u003cp\u003e131 (95%)\u003c/p\u003e\n \u003cp\u003e5 (4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2 (2%)\u003c/p\u003e\n \u003cp\u003e3 (2%)\u003c/p\u003e\n \u003cp\u003e126 (91%)\u003c/p\u003e\n \u003cp\u003e7 (5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eMarital status, n (%)\u003c/p\u003e\n \u003cp\u003eSingle\u003c/p\u003e\n \u003cp\u003eMarried/living with partner\u003c/p\u003e\n \u003cp\u003eDivorced/Widowed\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e79 (57%)\u003c/p\u003e\n \u003cp\u003e57 (41%)\u003c/p\u003e\n \u003cp\u003e2 (2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e82 (59%)\u003c/p\u003e\n \u003cp\u003e56 (41%)\u003c/p\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eBaby gender Girl, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e69 (50%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e62 (45%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eNumber of complete or incomplete pregnancies, n (%)\u003c/p\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e23 (17%)\u003c/p\u003e\n \u003cp\u003e113 (82%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;2 (1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e39 (28%)\u003c/p\u003e\n \u003cp\u003e97 (70%)\u003c/p\u003e\n \u003cp\u003e2 (2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eMode of delivery, n (%)\u003c/p\u003e\n \u003cp\u003eNormal delivery\u003c/p\u003e\n \u003cp\u003eAssisted normal delivery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e137 (99%)\u003c/p\u003e\n \u003cp\u003e1 (1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e136 (99%)\u003c/p\u003e\n \u003cp\u003e2 (1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eTime of HIV diagnosis\u003c/p\u003e\n \u003cp\u003eBefore pregnancy\u003c/p\u003e\n \u003cp\u003eDuring pregnancy\u003c/p\u003e\n \u003cp\u003eAt delivery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e121 (88%)\u003c/p\u003e\n \u003cp\u003e16 (11%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; 1 (1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e120 (87%)\u003c/p\u003e\n \u003cp\u003e18 (13%)\u003c/p\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eTime cART initiation, n (%) \u0026nbsp;\u003c/p\u003e\n \u003cp\u003eBefore pregnancy\u003c/p\u003e\n \u003cp\u003eDuring pregnancy\u003c/p\u003e\n \u003cp\u003eAt delivery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e123 (89%)\u003c/p\u003e\n \u003cp\u003e14 (10%)\u003c/p\u003e\n \u003cp\u003e1 (1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e118 (85%)\u003c/p\u003e\n \u003cp\u003e20 (15%)\u003c/p\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eDisclosure of HIV status to significant others, n (%) \u0026nbsp;\u003c/p\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e10 (7%)\u003c/p\u003e\n \u003cp\u003e128 (93%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e4 (3%)\u003c/p\u003e\n \u003cp\u003e134 (97%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 39.8589%;\"\u003e\n \u003cp\u003eBaby on antiretroviral prevention, n (%)\u003c/p\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003cp\u003eDon\u0026rsquo;t know\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 28.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e130 (94%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; 4 (3%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; 4 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 31.7461%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e131 (95%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; 0 (0%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; 7 (5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cdiv id=\"Sec27\"\u003e\n \u003ch2\u003eInfant feeding practices\u003c/h2\u003e\n \u003cdiv\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 2\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003eEstimate of breastfeeding rates at each study visit by study group.\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eIntervention group: n\u0026thinsp;=\u0026thinsp;138\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eStandard care group: n\u0026thinsp;=\u0026thinsp;138\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003en\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNumber of endpoints (%)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003en\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNumber of endpoints (%)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eExclusive breastfeeding\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"4\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 1 (week 2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e111\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e65 (59%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e110\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e73 (66%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 2 (week 6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e113\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e67 (59%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e115\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e59 (51%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 3 (week 10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e121\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e56 (46%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e119\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e41 (34%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 4 (week 24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e121\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e13 (11%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e120\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eAny form of breastfeeding\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"4\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 1 (week 2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e111\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e107 (96%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e110\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e108 (98%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 2 (week 6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e113\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e105 (93%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e115\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e110 (96%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 3 (week 10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e121\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e110 (91%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e119\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e107 (90%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 4 (week 24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e121\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e87 (72%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e120\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e92 (77%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003eExclusive breastfeeding practices were modest in both study groups through week 10 and dramatically dropped at week 24 (Table \u003cspan\u003e2\u003c/span\u003e). We found no significant effect of the intervention on exclusive breastfeeding rates at week 24, (6% versus 7%), rate difference \u0026minus;\u0026thinsp;1% (95% CI -6\u0026ndash;4%). After inputting missing outcome data, we found rate difference of -1% (95% CI -8\u0026ndash;5%) (Table \u003cspan\u003e3\u003c/span\u003e). The z-statistic of -0.36 did not exceed the predefined O\u0026rsquo;Brien-Fleming stopping boundary value of \u0026plusmn;\u0026thinsp;1.9776.\u003c/p\u003e\n \u003cdiv\u003e\n \u003ctable id=\"Tab3\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 3\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003eEstimate of breastfeeding rates, complete case analysis\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eIntervention group: n\u0026thinsp;=\u0026thinsp;138\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eStandard care group: n\u0026thinsp;=\u0026thinsp;138\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003en\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNumber of endpoints (%)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003en\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNumber of endpoints (%)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eRate difference (95% CI)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eCo-primary outcomes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"6\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eExclusive breastfeeding from childbirth to 24 weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e105\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e6 (6%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e101\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e7 (7%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.72\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e-0.01(-0.06 to 0.04)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAny form from breastfeeding from childbirth to 24 weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e105\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e79 (75%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e101\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e79 (78%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.61\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e-0.03 (-0.15 to 0.09)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eSecondary outcomes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"6\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eExclusive breastfeeding from childbirth to 6 weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e105\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e47 (45%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e105\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e43 (41%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.58\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.04 (-0.10 to 0.17)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAny form of breastfeeding from childbirth to 6 weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e105\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e98 (93%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e105\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e96 (91%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.02 (-0.05 to 0.09)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eExclusive breastfeeding from childbirth to 10 weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e105\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e29 (28%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e102\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e24 (24%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.04 (-0.08 to 0.16)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAny form of breastfeeding from childbirth to 10 weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e105\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e97 (92%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e102\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e91 (89%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.43\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.03 (-0.05 to 0.11)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAll-cause child hospitalization or death\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e105\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (2.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e9 (6.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003eThe odds of exclusive breastfeeding at week 24 were 19% non-significantly lower in the intervention group compared to the standard care group, OR 0.81 (95% CI 0.26 to 2.51), \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.72.\u003c/p\u003e\n \u003cp\u003eMost mothers continued breastfeeding while adding other foods through week 24 (Table \u003cspan\u003e2\u003c/span\u003e and \u003cspan\u003e3\u003c/span\u003e). The intervention had no effect on any form of breastfeeding rates (75% versus 78%), rate difference \u0026minus;\u0026thinsp;3% (95% CI -15\u0026ndash;9%) in complete case analysis and after inputting missing outcome data, -3% (95% CI -15\u0026ndash;9%) (Table \u003cspan\u003e3\u003c/span\u003e). The odds of any form of breastfeeding to week 24 were 15% non- significantly lower in the intervention group compared to the standard care group, OR 0.85 (95% CI 0.44 to 1.62), \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.61.\u003c/p\u003e\n \u003cp\u003eSixty-two of 276 (22%) (34 (25%) in the intervention group and 28 (20%) standard care group) mother-child pairs completely stopped breastfeeding before week 24. The median (IQR) age at time of stopping breastfeeding was 16 (6 to 20) weeks. Time to stopping breastfeeding was similar in the study groups, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.37, Fig.\u0026nbsp;2. The most common reasons reported by mothers for stopping breastfeeding were the mother needing to return to work or look for work, 66% (n\u0026thinsp;=\u0026thinsp;41) and insufficient breastmilk or child refused breastmilk, 19% (n\u0026thinsp;=\u0026thinsp;12).\u003c/p\u003e\n \u003cp\u003eFigure 2. Time to stopping any form of breastfeeding, by study group\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec28\"\u003e\n \u003ch2\u003eAll-cause child hospitalization or death\u003c/h2\u003e\n \u003cp\u003eThirteen children experienced 14 hospital admissions. Twelve children were each hospitalized once, and one child in the intervention group was hospitalized twice. Two hospitalized children died, one from each study group. The number of children hospitalized was not different between the intervention group and standard care group, 4 (2.9%) versus 9 (6.5%), \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.16. The intervention reduced the odds of hospitalization or death by 61%, OR 0.39 (95% CI 0.10 to 1.57), \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.19. Time to child death or first hospitalization was similar in the groups (Fig.\u0026nbsp;3), \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.18. Early breastfeeding cessation increased risk of child hospitalization or death compared to breastfeeding to 6 months, among children who completed all visits, 10% (5/48) versus 3% (5/158), \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.055. Early breastfeeding cessation more than tripled the odds of child hospitalization or death, OR 3.56 (95% CI 0.98 to 12.86).\u003c/p\u003e\n \u003cp\u003eFigure 3. Time to death or first hospitalization, by study group\u003c/p\u003e\n \u003cp\u003eMost children had diarrhea. Incidence of diarrhea decreased over time, rates were 91% at week 2, 86% at week 6, 63% at week 10 and 16% at week 24. Non-routine medically attended visits were similar; 29 in the intervention group and 30 for standard care.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec29\"\u003e\n \u003ch2\u003eInfant growth\u003c/h2\u003e\n \u003cp\u003eInfant growth was similar between study groups, (Figs.\u0026nbsp;4 and Table \u003cspan\u003e4\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eFigure 4. Mean weight for age z-score, weight for length z-score, length for age z-score, by study group\u003c/p\u003e\n \u003cp\u003eMean weight for age z-scores increased over time in both groups (Fig.\u0026nbsp;4), with no significant difference between groups, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.87. We found no significant difference in mean length for age z-scores, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.21 and mean weight for length z-scores, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.88.\u003c/p\u003e\n \u003cdiv\u003e\n \u003ctable id=\"Tab4\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 4\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003eInfant growth outcomes, mean z-scores by study group\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eStudy visit\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eIntervention\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eStandard care\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eMean difference (95% CI)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean weight for age z-score\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"3\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 2 (6 week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.14 ( -0.13 to 0.40)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 3 (10 week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.11 (-0.16 to 0.38)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 4 (24 week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.68\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.70\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.02 ( -0.32 to 0.28)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean length for age z-score\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"3\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 2 (6 week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.89\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.82\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.07( -0.49 to 0.36)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 3 (10 week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.28\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.57\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.29 ( -0.13 to 0.71)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 4 (24 week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.49\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.28\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.21 ( -0.22 to 0.63)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean weight for length z-score\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"3\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 2 (6 week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.10 ( -0.37 to 0.57)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 3 (10 week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.78\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.77\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.01 ( -0.45 to 0.48)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 4 (24 week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.76\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.82\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-0.06 ( -0.54 to 0.41)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003ch3\u003eSafety outcomes\u003c/h3\u003e\n\u003cp\u003eMost mothers reported cART adherence in the month prior to each visit as very good or excellent across all visits, rates of very good or excellent adherence ranged between 90% and 97%. Study participation led to no involuntary disclosure of HIV status. No mother reported relationship conflicts with their partners due to study participation. Child immunization profiles were similar across study groups, all infants received BCG at birth, 99% received the week 6, 10 and 14 immunizations and only 19% had received the six-month immunizations.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur primary objective was to demonstrate superiority of the intervention on sustaining exclusive breastfeeding to week 24 among mothers living with HIV in Western Cape Province, South Africa. However, we found no effect of motivational interviewing and text messaging compared to standard infant feeding counselling on exclusive breastfeeding or any form of breastfeeding rates at week 24. We however, found a marginal increase on exclusive breastfeeding rates in the intervention group through week 10, declining precipitously by week 24. The modest exclusive breastfeeding rates in early infancy within the standard infant feeding counselling group exceeded the 8% rate we initially expected. Our findings support a study reporting an increase in 4 to 8 weeks exclusive breastfeeding rates, coinciding with the Tshwane Declaration of support for breastfeeding [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]. Similarly, a cohort study found that South African mothers living with HIV breastfed exclusively in the first three weeks with a significant drop four months later [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. By 12 months of age, approximately 40% of children born to mothers living with HIV in South Africa are breastfed [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Exclusive breastfeeding rates are far below the global target of 50% at six months.\u003c/p\u003e \u003cp\u003eMost mothers introduced other foods before six months while breastfeeding. A comparison between the findings of our cohort study 12 years ago and our current trial demonstrate an improvement from 50% breastfeeding cessation rate [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e] to 22% in 2024. Additionally, there has been a marked increase in any form of breastfeeding practice over the past decade. The increase may be attributed to efforts at national and provincial levels to promote exclusive breastfeeding among mothers living with HIV, following adoption of the breastfeeding policy. However, early breastfeeding cessation remains a public health threat. Work-related demands influenced mothers\u0026rsquo; decision to stop breastfeeding. Various studies have shown that motivational interviewing and text messaging enhanced HIV viral load suppression, promoted weight loss, reduced alcohol and tobacco use and improved cART adherence [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e][\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e] [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]; the intervention positively impacted health conditions unlikely to interfere with the individual\u0026rsquo;s social or work-related demands. The combined intervention might not have met the socio-economic needs of the predominantly unemployed mothers. Our trial suggests that interventions focusing solely on the mother, without considering her socio-economic conditions will not improve exclusive breastfeeding rates. Maternal employment and schooling demands are key barriers to breastfeeding among mothers living with HIV [\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]. Infant feeding occurs within a broader context of family, socio-cultural, economic, and health care system. Innovative interventions responsive to socio-economic challenges faced by mothers of reproductive and working age may be more effective in achieving the global target of 50% exclusive breastfeeding rates.\u003c/p\u003e \u003cp\u003eThe common practice of any form of breastfeeding among mothers with high cART adherence contributed to low incidence of child hospitalization or death from any cause. The increased risk of child hospitalization or death among those who stopped breastfeeding emphasizes the benefits of any form of breastfeeding. This is consistent with other studies reporting an association between breastfeeding and infection-related hospitalization[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. The findings affirm the WHO guiding practice statement \u0026ldquo;practicing mixed feeding is not a reason to stop breastfeeding in the presence of cART\u0026rdquo;[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Most mothers acquired HIV infection before pregnancy and had low HIV viral loads. Child hospitalization or death profiles are likely worse where mothers present with incident HIV infection, high viral load or poor cART adherence. While finding interventions to enhance exclusive breastfeeding remains critical, HIV services should reliably offer cART, consistently monitor viral load, and support mothers cART adherence, especially where mixed feeding is common. Mothers who stopped breastfeeding did not consider expressing breastmilk as an alternative to continue breastfeeding. There are opportunities during routine infant feeding counselling to educate mothers about social or work demands that may arise during breastfeeding and potential solutions to enable breastfeeding even during these challenges.\u003c/p\u003e \u003cp\u003eOur trial had limitations. Our findings cannot be generalized to settings where mothers are employed with a stable source of income.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eSocio-economic pressures influenced mothers\u0026rsquo; decision to stop breastfeeding. Introduction of other foods before six months while breastfeeding remains common. Early cessation of breastfeeding is a public health threat. Finding interventions to enhance exclusive breastfeeding and the provision of high-quality HIV services remains critical. Innovative interventions responsive to socio-economic challenges faced by mothers may be more effective in improving exclusive breastfeeding rates.\u003c/p\u003e \u003cdiv id=\"Sec33\" class=\"Section2\"\u003e \u003ch2\u003eTrial status\u003c/h2\u003e \u003cp\u003eProtocol version number 1 31 May 2021, recruitment began on 22 July 2023, and trial follow up was completed on 15 May 2024.\u003c/p\u003e \u003c/div\u003e"},{"header":"Abbreviations","content":"\u003cp\u003ecART: combination antiretroviral treatment; WHO: World Health Organization; DSMB: Data Safety Monitoring Board; EDCTP: European \u0026amp; Developing Countries Clinical Trials Partnership; HEU: HIV exposed uninfected; HIV: Human immunodeficiency virus; PI: principal investigator; RALLOC: \u0026nbsp;random number generating command; REDCap: Research Electronic Data Capture; CONSORT: Consolidated Standards of Reporting Trials,\u0026nbsp;\u003c/p\u003e\n"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis project has received funding from the EDCTP2 programme (TMA2020CDF-3169-MTM-MI), supported by the European Union and the Fondation Botnar, South Africa Medical Research Council, Self-Initiated Research Grant, Stellenbosch University Subcommittee C, Stellenbosch University Early-Career Research Funding, Stellenbosch University temporary research assistance funding. The funders had no role in study design, data collection, data analysis, interpretation, preparation of the manuscript, or decision to publish.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest disclosure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStellenbosch University Human Research Ethics committee (reference M21/03/010) approved the study. Western Cape Department of Health approved access to Khayelitsha District Hospital for study recruitment (reference WC_202107_007). Mothers signed a written informed consent form for their and their child\u0026rsquo;s participation in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatient consent statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable. Study results are presented in aggregate format in technical reports and journal publications. A model consent form is provided on request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePermission to reproduce material from other sources\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial registration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial was registered on ClinicalTrials.gov (NCT05063240) and Pan African Clinical Trial Registries (PACTR202110870407786) before recruitment of the first subject.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWorld Health Organization, United Nations Children\u0026rsquo;s Fund. Guideline: updates on HIV and infant feeding: the duration of breastfeeding, and support from health services to improve feeding practices among mothers living with HIV. Geneva: World Health Organ. 2016. \u003c/li\u003e\n\u003cli\u003eRollins N, Bhandari N, Hajeebhoy N. Why invest, and what it will take to improve breastfeeding practices? Lancet. 2016;387(10017):491\u0026ndash;504. \u003c/li\u003e\n\u003cli\u003eSankar MJ, Sinha B, Chowdhury R, Bhandari N, Taneja S, Martines J, et al. Optimal breastfeeding practices and infant and child mortality: A systematic review and meta-analysis. Vol. 104, Acta Paediatrica, International Journal of Paediatrics. 2015. \u003c/li\u003e\n\u003cli\u003eSinha B, Chowdhury R, Upadhyay RP, Taneja S, Martines J, Bahl R, et al. Integrated interventions delivered in health systems, home, and community have the highest impact on breastfeeding outcomes in low- and middle-income countries. Journal of Nutrition. 2017;147(11). \u003c/li\u003e\n\u003cli\u003eVictora CG, Bahl R, Barros AJD, Fran\u0026ccedil;a GVA, Horton S, Krasevec J, et al. Breastfeeding in the 21st century: Epidemiology, mechanisms, and lifelong effect. Vol. 387, The Lancet. 2016. \u003c/li\u003e\n\u003cli\u003eMyer L, Phillips T. Beyond \u0026lsquo;Option B+.\u0026rsquo; JAIDS. 2017;75(Suppl 2):S115\u0026ndash;S122. \u003c/li\u003e\n\u003cli\u003eFlynn PM, Taha TE, Cababasay M, Fowler MG, Mofenson LM, Owor M, et al. Prevention of HIV-1 transmission through breastfeeding: Efficacy and safety of maternal antiretroviral therapy versus infant nevirapine prophylaxis for duration of breastfeeding in HIV-1-infected women with high cd4 cell count (IMPAACT PROMISE): A randomized, open-label, clinical trial. J Acquir Immune Defic Syndr (1988). 2018;77(4). \u003c/li\u003e\n\u003cli\u003eNor B, Ahlberg BM, Doherty T, Zembe Y, Jackson D, Ekstr\u0026ouml;m EC. Mother\u0026rsquo;s perceptions and experiences of infant feeding within a community-based peer counselling intervention in South Africa. Matern Child Nutr. 2012;8(4). \u003c/li\u003e\n\u003cli\u003eKedir M, Mengistu YG. Assessment of Infant Feeding Practice Among HIV Positive Mothers and HIV Status of Their Infants in Adama Hospital, Oromia Regional State, Ethiopia, 2016. J Pregnancy Child Health. 2017;04(05). \u003c/li\u003e\n\u003cli\u003eAishat U, David D, Olufunmilayo F. Exclusive breastfeeding and HIV/AIDS: A crossectional survey of mothers attending prevention of mother-to-child transmission of HIV clinics in southwestern Nigeria. Pan African Medical Journal. 2015;21. \u003c/li\u003e\n\u003cli\u003eDavis NL, Miller WC, Hudgens MG, Chasela CS, Sichali D, Kayira D, et al. Maternal and breastmilk viral load: Impacts of adherence on peripartum HIV infections averted - The breastfeeding, antiretrovirals, and nutrition study. J Acquir Immune Defic Syndr (1988). 2016;73(5). \u003c/li\u003e\n\u003cli\u003eMS K, R K. Optimal duration of exclusive breastfeeding. 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Infant and young child feeding. \u003c/li\u003e\n\u003cli\u003eDoherty T, Sanders D, Jackson D, Swanevelder S, Lombard C, Zembe W, et al. Early cessation of breastfeeding amongst women in South Africa: an area needing urgent attention to improve child health. BMC Pediatr. 2012;12. \u003c/li\u003e\n\u003cli\u003eNational Department of Health, Statistics South Africa, South African Medical Research Council, ICF. South Africa demographic and health survey 2016: Key indicators. Pretoria, South Africa and Rockville, Maryland, USA: NDoH, Stats SA, SAMRC, and ICF,. 2017. \u003c/li\u003e\n\u003cli\u003eSamburu BM, Young SL, Wekesah FM, Wanjohi MN, Kimiywe J, Muriuki P, et al. Effectiveness of the baby-friendly community initiative in promoting exclusive breastfeeding among HIV negative and positive mothers: A randomized controlled trial in Koibatek Sub-County, Baringo, Kenya. Int Breastfeed J. 2020;15(1). \u003c/li\u003e\n\u003cli\u003eNjom Nlend AE, Motaze ACN, Sandie A, Fokam J. HIV-1 transmission and survival according to feeding options in infants born to HIV-infected women in Yaound\u0026eacute;, Cameroon. BMC Pediatr. 2018;18(1). \u003c/li\u003e\n\u003cli\u003eChaponda A, Goon DT, Hoque ME. Infant feeding practices among HIV-positive mothers at Tembisa hospital, South Africa. Afr J Prim Health Care Fam Med. 2017;9(1). \u003c/li\u003e\n\u003cli\u003eHumphrey J. The risks of not breastfeeding. J Acquir Immune Defic Syndr. 2010;53(1):1\u0026ndash;4. \u003c/li\u003e\n\u003cli\u003eKimani-Murage EW, Wekesah F, Wanjohi M, Kyobutungi C, Ezeh AC, Musoke RN, et al. Factors affecting actualisation of the WHO breastfeeding recommendations in urban poor settings in Kenya. Matern Child Nutr. 2015;11(3). \u003c/li\u003e\n\u003cli\u003eNyoni S, Sweet L, Clark J, Ward P. A realist review of infant feeding counselling to increase exclusive breastfeeding by HIV-positive women in sub Saharan-Africa: What works for whom and in what contexts. BMC Public Health. 2019;19(1). \u003c/li\u003e\n\u003cli\u003eStatistics South Africa. Statistics South Africa. Mid-year population estimates 2017. https://www.statssa.gov.za/publications/P0302/P03022017.pdf.; 2017. \u003c/li\u003e\n\u003cli\u003eKharsany ABM, Frohlich JA, Yende-Zuma N, Mahlase G, Samsunder N, Dellar RC, et al. Trends in HIV prevalence in pregnant women in rural South Africa. J Acquir Immune Defic Syndr (1988). 2015;70(3). \u003c/li\u003e\n\u003cli\u003eDepartment of Health. The Tshwane Declaration of Support for Breastfeeding in South Africa. South African Journal of Clinical Nutrition. 2011;24(4). \u003c/li\u003e\n\u003cli\u003eGoga AE, Doherty T, Jackson DJ, Sanders D, Colvin M, Chopra M, et al. Infant feeding practices at routine PMTCT sites, South Africa: Results of a prospective observational study amongst HIV exposed and unexposed infants - birth to 9 months. Int Breastfeed J. 2012;7. \u003c/li\u003e\n\u003cli\u003eJones DL, Rodriguez VJ, Mandell LN, Lee TK, Weiss SM, Peltzer K. Influences on Exclusive Breastfeeding Among Rural HIV-Infected South African Women: A Cluster Randomized Control Trial. AIDS Behav. 2018;22(9). \u003c/li\u003e\n\u003cli\u003eIribarren S, Beck S, Pearce P, Chirico C, Etchevarria, M Cardinale D, Rubinstein F. TextTB: A mixed method pilot study evaluating acceptance, feasibility, and exploring initial efficacy of a text messaging intervention to support TB treatment adherence. Tuberc Res Treat. 2013;2013. \u003c/li\u003e\n\u003cli\u003eDick J, Nundy S, Solomon M, Bishop K, Chin M, Peek M. Feasibility and usability of a text message-based program for diabetes self-management in an urban African-American population. J Diabetes Sci Technol. 2011;5(5):1246\u0026ndash;54. \u003c/li\u003e\n\u003cli\u003ePop-Eleches, C Thirumurthy, H Habyarimana J, Zivin J, Goldstein M, de Walque D, MacKeen L, Haberer J, et al. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011;25(6):825\u0026ndash;34. \u003c/li\u003e\n\u003cli\u003eMiller W, Rollnick S. Motivational interviewing: preparing people to change behaviour. New York: Guilford Press; 1991. \u003c/li\u003e\n\u003cli\u003eChinkonde JR, Hem MH, Sundby J. HIV and infant feeding in Malawi: Public health simplicity in complex social and cultural contexts. BMC Public Health. 2012;12(1). \u003c/li\u003e\n\u003cli\u003eOdeny BM, Pfeiffer J, Farquhar C, Igonya EK, Gatuguta A, Kagwaini F, et al. The Stigma of Exclusive Breastfeeding among Both HIV-Positive and HIV-Negative Women in Nairobi, Kenya. Breastfeeding Medicine. 2016;11(5). \u003c/li\u003e\n\u003cli\u003eHazemba AN, Ncama BP, Sithole SL. Promotion of exclusive breastfeeding among HIV-positive mothers: An exploratory qualitative study. Int Breastfeed J. 2016;11(1). \u003c/li\u003e\n\u003cli\u003eIjumba P, Doherty T, Jackson D, Tomlinson M, Sanders D, Persson L\u0026Aring;. Free formula milk in the prevention of mother-to-child transmission programme: Voices of a peri-urban community in South Africa on policy change. Health Policy Plan. 2013;28(7). \u003c/li\u003e\n\u003cli\u003eZunza M, Thabane L, Kuhn L, Els C, Cotton MF, Young T. Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI). Trials. 2023;24(1). \u003c/li\u003e\n\u003cli\u003eSchulz KF, Altman DG, Moher D. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. BMJ (Online). 2010;340(7748). \u003c/li\u003e\n\u003cli\u003eWorld Health Organization. Breastfeeding and replacement feeding practices in the context of mother-to-child transmission of HIV: an assessment tool for research and programs. Geneva: WHO. 2001. \u003c/li\u003e\n\u003cli\u003eJackson D, Swanevelder S, Doherty T, Lombard C, Bhardwaj S, Goga A. Changes in rates of early exclusive breastfeeding in South Africa from 201 to 2013: data from three national surveys before and during implementation of a change in national breastfeeding policy. BMJ Open. 2019;9(11). \u003c/li\u003e\n\u003cli\u003eZunza M, Esser M, Slogrove A, Bettinger JA, Machekano R, Cotton MF. Early Breastfeeding Cessation Among HIV‑Infected and HIV‑Uninfected Women in Western Cape Province, South Africa. AIDS Behav. 2018;22:S114\u0026ndash;S120. \u003c/li\u003e\n\u003cli\u003eNabulsi M. Why are breastfeeding rates low in Lebanon? a qualitative study. BMC Pediatr. 2011;11. \u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"international-breastfeeding-journal","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ibfj","sideBox":"Learn more about [International Breastfeeding Journal](http://internationalbreastfeedingjournal.biomedcentral.com/)","snPcode":"13006","submissionUrl":"https://submission.nature.com/new-submission/13006/3","title":"International Breastfeeding Journal","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Breastfeeding, HIV/AIDS, mobile phone text messaging, motivational interviewing","lastPublishedDoi":"10.21203/rs.3.rs-5132328/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5132328/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eIntroduction\u003c/h2\u003e \u003cp\u003eBreastfeeding improves child health, development and survival, particularly in regions where diarrhoea, pneumonia and undernutrition are leading causes of death in children under five. Despite awareness of exclusive breastfeeding benefits and efforts to promote optimal infant feeding practices, the practice of exclusive breastfeeding is low. We conducted a trial to determine whether text messaging plus motivational interviewing increase uptake of exclusive breastfeeding, prolong exclusive breastfeeding and improve child health outcomes.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eWe conducted the trial between July 2022 and May 2024, at a secondary-level healthcare facility in South Africa. Mothers living with HIV and their infant, initiating breastfeeding, on cART, 18 years or older, were randomly assigned to either weekly text messaging plus in-person motivational interviewing or standard infant feeding counselling for six months. The randomization allocation sequence was computer generated and assignment was done centrally.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eMother-child pairs (n\u0026thinsp;=\u0026thinsp;276) were randomly allocated to receive intervention (n\u0026thinsp;=\u0026thinsp;138) or standard infant feeding counselling. One hundred five and 101 mother-child pairs in the intervention group and standard care group, respectively, had primary outcome data evaluation across all four study visits. We found no significant effect of the intervention on exclusive breastfeeding rates at week 24, (6% versus 7%), rate difference \u0026minus;\u0026thinsp;1% (95% CI -6\u0026ndash;4%). Sixty-two of 276 (22%) mother-child pairs completely stopped breastfeeding before week 24. The most common reasons for stopping breastfeeding were the mother needing to return to work or look for work, 66% (n\u0026thinsp;=\u0026thinsp;41). We also found that early breastfeeding cessation increased risk of child hospitalization or death compared to any form of breastfeeding to week 24, 10% (5/48) versus 3% (5/158), p\u0026thinsp;=\u0026thinsp;0.055.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eSocio-economic pressures influenced mothers\u0026rsquo; decision to stop breastfeeding. Introduction of other foods before six months while breastfeeding remains common. Early cessation of breastfeeding is a public health threat. While finding interventions to enhance exclusive breastfeeding remains critical, HIV services should reliably offer cART, consistently monitor viral load, and support mothers cART adherence, especially where mixed feeding is common. Innovative interventions responsive to socio-economic challenges faced by mothers of reproductive and working age may be more effective in improving exclusive breastfeeding rates.\u003c/p\u003e","manuscriptTitle":"A randomized controlled, trial on effects of mobile phone text messaging in combination with motivational interviewing versus standard infant feeding counselling on breastfeeding and child health outcomes, among women living with HIV","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-25 23:28:18","doi":"10.21203/rs.3.rs-5132328/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-11-08T01:48:14+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-11-04T07:57:36+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-10-22T07:06:12+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-10-21T15:12:24+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"219858405301741178308482168155578763640","date":"2024-09-30T12:15:15+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"78120669858539726050550246127747414097","date":"2024-09-30T11:15:39+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"144541480619612946947055482551166061331","date":"2024-09-29T07:17:52+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-09-29T03:40:03+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-09-27T14:17:49+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-09-27T14:15:21+00:00","index":"","fulltext":""},{"type":"submitted","content":"International Breastfeeding Journal","date":"2024-09-22T12:04:17+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"international-breastfeeding-journal","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ibfj","sideBox":"Learn more about [International Breastfeeding Journal](http://internationalbreastfeedingjournal.biomedcentral.com/)","snPcode":"13006","submissionUrl":"https://submission.nature.com/new-submission/13006/3","title":"International Breastfeeding Journal","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"80f0c10f-8e97-4a9c-b6a3-d3177c7105e3","owner":[],"postedDate":"November 25th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-01-27T16:09:16+00:00","versionOfRecord":{"articleIdentity":"rs-5132328","link":"https://doi.org/10.1186/s13006-024-00693-2","journal":{"identity":"international-breastfeeding-journal","isVorOnly":false,"title":"International Breastfeeding Journal"},"publishedOn":"2025-01-20 15:57:45","publishedOnDateReadable":"January 20th, 2025"},"versionCreatedAt":"2024-11-25 23:28:18","video":"","vorDoi":"10.1186/s13006-024-00693-2","vorDoiUrl":"https://doi.org/10.1186/s13006-024-00693-2","workflowStages":[]},"version":"v1","identity":"rs-5132328","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5132328","identity":"rs-5132328","version":["v1"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}