Development and piloting of a primary school-based salt reduction programme: Formative work and a process evaluation in rural and urban Malawi.

Excess salt intake is a major modifiable risk factor for cardiovascular disease. Promoting salt reduction as part of routine school-health programming may be a pragmatic way to address this risk factor early in the life course but has not been tested in sub-Saharan Africa (SSA). Here we describe the formative work with stakeholders and process evaluation of pilot work to develop a school-based salt reduction programme for children aged 11-14 years, in preparation for a cluster-randomised trial in rural/urban Malawi. Collection of observational data and documentary evidence (meeting minutes/field notes) from the earliest key stakeholder engagement with Malawi Ministries of Health, Education, Local Government and Rural Development and Malawi Institute of Education, and non-governmental stakeholders; and a series of semi-structured interviews and focus groups (with head teachers (n = 2); teachers (n = 4); parents (n = 30); and learners (n = 40)). Data was analysed thematically and conceptualised through a Normalization Process Theory lens. Formative work illustrated a range of administrative, technical, and practical issues faced during development of the programme; including allocation of stakeholder roles and responsibilities, harmonisation with pre-existing strategies and competing priorities, resources required for programme development, and design of effective teaching materials. While participants were positive about the programme, the process evaluation identified features to be refined including perceived challenges to participation, recommended adaptations to the content and delivery of lessons, and concerns related to quantity/quality of learning resources provided. This study demonstrates the importance of comprehensive, sustained, and participatory stakeholder engagement in the development of a novel school health programme in SSA; and highlights the factors that were critical to successfully achieving this. We also demonstrate the value of detailed process evaluation in informing development of the programme to ensure that it was feasible and relevant to the context prior to evaluation through a cluster-randomised trial.

"I do all I can but I still fail them": Health system barriers to providing Option B+ to pregnant and lactating women in Malawi.

Malawi's Option B+ program is based on a 'test and treat' strategy that places all HIV-positive pregnant and lactating women on lifelong antiretroviral therapy. The steep increase in patient load placed severe pressure on a health system that has struggled for decades with inadequate supply of health care workers (HCWs) and poor infrastructure. We set out to explore health system barriers to Option B+ by asking HCWs in Malawi about their experiences treating pregnant and lactating women. We observed and conducted semi-structured interviews (SSIs) with 34 HCWs including nine expert clients (ECs) at 14 health facilities across Malawi, then coded and analyzed the data. We found that HCWs implementing Option B+ are so overburdened in Malawi that it reduces their ability to provide quality care to patients, who receive less counseling than they should, wait longer than is reasonable, and have very little privacy. Interventions that increase the number of HCWs and upgrade infrastructure to protect the privacy of HIV-infected pregnant and lactating women and their husbands could increase retention, but facilities will need to be improved to support men who accompany their partners on clinic visits.

Timing of combination antiretroviral therapy (cART) initiation is not associated with stillbirth among HIV-infected pregnant women in Malawi.

OBJECTIVE: To assess the association between timing of maternal combination ART (cART) initiation and stillbirth among HIV-infected pregnant women in Malawi's Option B+ programme. METHODS: Cohort study of HIV-infected pregnant women delivering singleton live or stillborn babies at ≥28 weeks of gestation using routine data from maternity registers between 1 January 2012 and 30 June 2015. We defined stillbirth as death of a foetus at ≥28 weeks of gestation. We report proportions of stillbirth according to timing of maternal cART initiation (before pregnancy, 1st or 2nd trimester, or 3rd trimester or labour). We used logistic regression, with robust standard errors to account for clustering of women within health facilities, to investigate the association between timing of cART initiation and stillbirth. RESULTS: Of 10 558 mother-infant pairs abstracted from registers, 8380 (79.4%) met inclusion criteria. The overall rate of stillbirth was 25 per 1000 deliveries (95% confidence interval 22-29). We found no significant association between timing of maternal cART initiation and stillbirth. In multivariable models, older maternal age, male sex of the infant, breech vaginal delivery, delivery at < 34 weeks of gestation and experience of any maternal obstetric complication were associated with higher odds of stillbirth. Deliveries managed by a mission hospital or health centre were associated with lower odds of stillbirth. CONCLUSION: Pregnant women's exposure to cART, regardless of time of its initiation, was not associated with increased odds of stillbirth.

OBJECTIF: Evaluer l'association entre le moment d'initiation de l'ART de combinaison (cART) maternel et la mortinaissance chez les femmes enceintes infectées par le VIH dans le programme Option B+ du Malawi. MÉTHODES: Etude de cohorte de femmes enceintes infectées par le VIH qui ont accouché de bébés singletons vivants ou mort-nés à 28 mois ou plus de grossesse, en utilisant les données de routine des registres de maternité entre le 1er janvier 2012 et le 30 juin 2015. Nous avons défini la mortinatalité comme le décès d'un fœtus à 28 semaines ou plus de gestation. Nous rapportons sur les proportions de mortinatalité selon le moment de l'initiation du cART maternel (avant la grossesse, au 1er , 2è ou 3è trimestre ou durant le travail). Nous avons utilisé une régression logistique, avec des erreurs standards robustes, pour prendre en compte le regroupement des femmes par établissements de santé, afin d'investiguer le lien entre le moment d'initiation du cART et la mortinaissance. RÉSULTATS: Sur 10.558 paires mère-enfant extraites des registres, 8.380 (79,4%) répondaient aux critères d'inclusion. Le taux global de mortinatalité était de 25 pour 1.000 accouchements (intervalle de confiance à 95%: 22-29). Nous n'avons trouvé aucune association significative entre le moment de l'initiation du cART maternel et la mortinatalité. Dans les modèles multivariés, l'âge plus élevé de la mère, le sexe masculin du nourrisson, l'accouchement par voie basse, l'accouchement à moins de 34 semaines de gestation et l'expérience de toute complication obstétricale maternelle étaient associés à des probabilités de mortinatalité plus élevées. Les accouchements gérés par un hôpital de la mission ou un centre de santé étaient associés à une probabilité plus faible de mortinatalité. CONCLUSION: L'exposition des femmes enceintes au cART quel que soit le moment de son initiation, n'a pas été associée à une probabilité accrue de mortinatalité.

Weight gain of HIV-exposed, uninfected children born before and after introduction of the 'Option B+' programme in Malawi.

OBJECTIVE: To compare birth weight and weight gain in HIV-exposed, uninfected (HEU) infants up to 24 months old, who enrolled in the Malawian national HIV care clinic (HCC) programme either before or after Option B+ (OB+) was implemented. DESIGN, SETTING AND PARTICIPANTS: HIV-exposed infants enrol in the HCC programme as soon as possible after birth and are followed up to at least 24 months old. This analysis includes HEU infants with recorded birth weight, date of birth, gender and at least one follow-up weight measurement from 21 health facilities in central and southern Malawi (January 2010-December 2014). Weight-for-age z scores (WAZ) were derived and compared by birth period using linear regression at birth and mixed effects models for postnatal weight gain up to 24 months old. RESULTS: Of 6845 HEU infants included in this study, 88.5% were born after OB+. The proportion of infants exposed in utero to combination antiretroviral therapy (ART) significantly increased after OB+ was implemented, and infants were exposed to ART for a longer time. There was no significant difference in WAZ at birth (P = 0.654) among HEU infants by birth period, but postnatal weight gain was faster among HEU infants born in the Option B+ period than infants born pre-Option B+. CONCLUSION: Birth weight was not affected by longer exposure to ART during pregnancy after OB+ was introduced, when weight gain in HEU infants was faster, possibly because their mothers were in better health.

"I found that I was well and strong": Women's motivations for remaining on ART under Option B+ in Malawi.

Most Malawian women who start ART under Option B+ are still in care three years later, a higher than average adherence rate for life-threatening chronic disease treatments, worldwide (50%). We asked 75 Malawian on ART their motivations for remaining in treatment, and what barriers they overcame. Focus groups and interviews included 75 women on ART for 6+ months, at 12 health facilities. Four main motivations for continuing ART emerged: 1) evidence that ART improved their own and their children's health; 2) strong desire to be healthy and keep their children healthy; 3) treatment was socially supported; 4) HIV/ART counselling effectively showed benefits of ART and told women what to expect. Women surmounted the following barriers: 1) stigma; 2) health care system; 3) economic; 4) side effects. Women stayed on ART because they believed it works. Future interventions should focus on emphasizing ART's effectiveness, along with other services they provide.

Patterns of caesarean section in HIV infected and non-infected women in Malawi: is caesarean section used for PMTCT?

BACKGROUND: Caesarean section (CS) is not recommended for PMTCT in Malawi HIV Guidelines, contrary to most high-income countries where CS is indicated if viral suppression is sub-optimal pre-delivery. We describe patterns of CS in HIV-infected and uninfected women in Malawi and explored if insight into the use of Elective CS (ECS) for PMTCT could be obtained. METHODS: We used routinely collected data from individual medical records from 17 large health facilities in the central and southern regions of Malawi, from January 2010 to December 2013. We included data from maternity registers from all HIV-positive women, and randomly selected around every fourth woman with negative or unknown HIV status. We used multivariable logistic regressions and cluster-based robust standard errors to examine independent associations of patient- and facility characteristics with CS and ECS. RESULTS: We included 62,033 women in the analysis. The weighted percentage of women who had a spontaneous vaginal delivery was 80.0% (CI 95% 79.5-80.4%); 2.4% (95% CI 2.3-2.6%) had a vacuum extraction; 2.3% (95% CI 2.2-2.5%) had a vaginal breech delivery; 14.0% (95% CI 13.6-14.4%) had a CS while for 1.3% (95% CI 1.2-1.4%) the mode of delivery was not recorded. Prevalence of CS without recorded medical or obstetric indication (ECS) was 5.1%, (n = 3152). Presence of maternal and infant complications and older age were independently associated with CS delivery. HIV-positive women were less likely to have ECS than HIV negative women (aOR 0.65; 95%-CI 0.57-0.74). Among HIV-positive women, those on antiretrovirals (ARV's) for ≥4 weeks prior to delivery were less likely to have ECS than HIV-positive women who had not received ARVs during pregnancy (aOR 0.81; 95% CI 0.68-0.96). CONCLUSIONS: The pattern of CS's in Malawi is largely determined by maternal and infant complications. Positive HIV status was negatively associated with CS delivery, possibly because health care workers were concerned about the risk of occupational HIV transmission and the known increased risk of post-operative complications. Our results leave open the possibility that CS is practiced to prevent MTCT given that ECS was more common among women at high risk of MTCT due to no or short exposure to ARV's.

HIV transmission and retention in care among HIV-exposed children enrolled in Malawi's prevention of mother-to-child transmission programme.

INTRODUCTION: In Malawi, HIV-infected pregnant and breastfeeding women are offered lifelong antiretroviral therapy (ART) regardless of CD4 count or clinical stage (Option B+). Their HIV-exposed children are enrolled in the national prevention of mother-to-child transmission (PMTCT) programme, but many are lost to follow-up. We estimated the cumulative incidence of vertical HIV transmission, taking loss to follow-up into account. METHODS: We abstracted data from HIV-exposed children enrolled into care between September 2011 and June 2014 from patient records at 21 health facilities in central and southern Malawi. We used competing risk models to estimate the probability of loss to follow-up, death, ART initiation and discharge, and used pooled logistic regression and inverse probability of censoring weighting to estimate the vertical HIV transmission risk. RESULTS: A total of 11,285 children were included; 9285 (82%) were born to women who initiated ART during pregnancy. At age 30 months, an estimated 57.9% (95% CI 56.6-59.2) of children were lost to follow-up, 0.8% (0.6-1.0) had died, 2.6% (2.3-3.0) initiated ART, 36.5% (35.2-37.9) were discharged HIV-negative and 2.2% (1.5-2.8) continued follow-up. We estimated that 5.3% (95% CI 4.7-5.9) of the children who enrolled were HIV-infected by the age of 30 months, but only about half of these children (2.6%; 95% CI 2.3-2.9) were diagnosed. CONCLUSIONS: Confirmed mother-to-child transmission rates were low, but due to poor retention only about half of HIV-infected children were diagnosed. Tracing of children lost to follow-up and HIV testing in outpatient clinics should be scaled up to ensure that all HIV-positive children have access to early ART.

A mixed method study exploring adherence to and acceptability of small quantity lipid-based nutrient supplements (SQ-LNS) among pregnant and lactating women in Ghana and Malawi.

BACKGROUND: Supplementing pregnant and lactating mothers with small quantity lipid-based nutrient supplements (SQ-LNS) has resulted in improvements in birth outcomes in some low-income settings. In order to be effective, SQ-LNS must be consumed regularly over sustained periods. METHODS: The objective was to assess and compare acceptability of and adherence to SQ-LNS consumption among pregnant and lactating women in Ghana and Malawi throughout 12 months of supplementation. We enrolled women before 20 gestation weeks into randomized trials in Ghana (n = 1320) and Malawi (n = 869). In the SQ-LNS group participants received a 20 g sachet of supplement per day during pregnancy and the first 6 months of lactation. In the control groups participants received multiple micronutrients (MMN) during pregnancy and lactation or iron and folic acid (IFA) during pregnancy and calcium during lactation. We used questionnaires to collect data on self-reported adherence to daily use of supplements and conducted in-depth interviews with women in the SQ-LNS group to examine acceptability. RESULTS: The mean self-reported adherence during the supplementation period was lower in Ghana (79.9 %) than in Malawi (91.7 %) for all supplements (difference 11.8 %, P < 0.001). Over time, adherence increased in Malawi but decreased in Ghana. In both countries, adherence in the SQ-LNS group was non-inferior to that in the control groups. Participants typically reported consuming SQ-LNS as instructed but when interviewers queried about experiences, most of the women described incidents of non-adherence. A usual reason for not consuming SQ-LNS was nausea and vomiting during pregnancy. Especially in Malawi, women reported sharing SQ-LNS with families and friends. Sustained use of SQ-LNS was attributed to expected health benefits and favorable sensory attributes. Often women compared their pregnancy to previous ones, and were of the view that SQ-LNS made a positive difference. CONCLUSION: Self-reported sustained adherence to consume SQ-LNS daily was high in both sites but lower in Ghana than in Malawi. In Ghana, adherence decreased over time whereas in Malawi adherence increased. Acceptability and adherence appeared interlinked, complex and context-related. Sustained consumption of SQ-LNS may require tailoring interventions by context. TRIAL REGISTRATION: The Ghana trial was registered at clinicaltrials.gov as NCT00970866 , and the Malawi trial as NCT01239693 .

Adherence to Antiretroviral Therapy During and After Pregnancy: Cohort Study on Women Receiving Care in Malawi's Option B+ Program.

BACKGROUND: Adherence to antiretroviral therapy (ART) is crucial to preventing mother-to-child transmission of human immunodeficiency virus (HIV) and ensuring the long-term effectiveness of ART, yet data are sparse from African routine care programs on maternal adherence to triple ART. METHODS: We analyzed data from women who started ART at 13 large health facilities in Malawi between September 2011 and October 2013. We defined adherence as the percentage of days "covered" by pharmacy claims. Adherence of ≥90% was deemed adequate. We calculated inverse probability of censoring weights to adjust adherence estimates for informative censoring. We used descriptive statistics, survival analysis, and pooled logistic regression to compare adherence between pregnant and breastfeeding women eligible for ART under Option B+, and nonpregnant and nonbreastfeeding women who started ART with low CD4 cell counts or World Health Organization clinical stage 3/4 disease. RESULTS: Adherence was adequate for 73% of the women during pregnancy, for 66% in the first 3 months post partum, and for about 75% during months 4-21 post partum. About 70% of women who started ART during pregnancy and breastfeeding adhered adequately during the first 2 years of ART, but only about 30% of them had maintained adequate adherence at every visit. Risk factors for inadequate adherence included starting ART with an Option B+ indication, at a younger age, or at a district hospital or health center. CONCLUSIONS: One-third of women retained in the Option B+ program adhered inadequately during pregnancy and breastfeeding, especially soon after delivery. Effective interventions to improve adherence among women in this program should be implemented.

Provision of 10-40 g/d Lipid-Based Nutrient Supplements from 6 to 18 Months of Age Does Not Prevent Linear Growth Faltering in Malawi.

BACKGROUND: Complementing infant diets with lipid-based nutrient supplements (LNSs) has been suggested to improve growth and reduce morbidity, but the daily quantity and the milk content of LNSs affect their cost. OBJECTIVE: We tested the hypotheses that the change in mean length-for-age z score (LAZ) for infants provided with 10-40 g LNSs/d from ages 6 to 18 mo would be greater than that for infants receiving no dietary intervention at the same age and that provision of LNSs that did not contain milk would be as good as milk-containing LNSs in promoting linear growth. METHODS: We enrolled in a randomized single-blind trial 6-mo-old infants who were allocated to 1 of 6 groups to receive 10, 20, or 40 g LNSs/d containing milk powder; 20 or 40 g milk-free LNSs/d; or no supplement until 18 mo of age. The primary outcome was change in LAZ. RESULTS: Of the 1932 enrolled infants, 78 (4.0%) died and 319 (16.5%) dropped out during the trial. The overall reported supplement consumption was 71.6% of days, with no difference between the groups (P = 0.26). The overall mean ± SD length and LAZ changes were 13.0 ± 2.1 cm and -0.45 ± 0.77 z score units, respectively, which did not differ between the groups (P = 0.66 for length and P = 0.74 for LAZ). The difference in mean LAZ change in the no-milk LNS group compared with the milk LNS group was -0.02 (95% CI: -0.10, 0.06; P = 0.72). CONCLUSION: Our results do not support the hypothesis that LNS supplementation during infancy and childhood promotes length gain or prevents stunting between 6 and 18 mo of age in Malawi. This trial was registered at clinicaltrials.gov as NCT00945698.

Supplementation of Maternal Diets during Pregnancy and for 6 Months Postpartum and Infant Diets Thereafter with Small-Quantity Lipid-Based Nutrient Supplements Does Not Promote Child Growth by 18 Months of Age in Rural Malawi: A Randomized Controlled Trial.

BACKGROUND: Intrauterine growth restriction may be reduced by supplementing maternal diets during pregnancy, but few studies have assessed the impact of combined prenatal and postnatal interventions on child growth. OBJECTIVE: We tested a hypothesis that provision of small-quantity lipid-based nutrient supplements (SQ-LNSs) to mothers in pregnancy and 6 mo postpartum and to their infants from 6 to 18 mo of age would promote infant and child growth in the study area in rural Malawi. METHODS: We enrolled 869 pregnant women in a randomized trial in Malawi. During pregnancy and 6 mo thereafter, the women received daily 1 capsule of iron-folic acid (IFA), 1 capsule containing 18 micronutrients (MMN), or one 20-g sachet of SQ-LNS [lipid-based nutrient supplements (LNS), containing 21 MMN, protein, carbohydrates, essential fatty acids, and 118 kcal]. Children in the IFA and MMN groups received no supplementation; children in the LNS group received SQ-LNSs from 6 to 18 mo. Primary outcome was child length at 18 mo. RESULTS: At 18 mo, the mean length in the IFA, MMN, and LNS groups was 77.0, 76.9, and 76.8 cm (P = 0.90), respectively, and the prevalence of stunting was 32.7%, 35.6%, and 37.9% (P = 0.54), respectively. No intergroup differences were found in the mean weight, head circumference, or midupper arm circumference or the proportions with low z scores for these variables (P > 0.05). Covariate adjustment did not change the analysis results, and the associations between the intervention and child length were not modified by maternal parity, age, or nutritional status (P > 0.10). CONCLUSIONS: The findings do not support a hypothesis that provision of SQ-LNSs to women in pregnancy and postpartum and to children from 6 to 18 mo of age would promote child growth in this Malawian study area. This trial was registered at clinicaltrials.gov as NCT01239693.

Malawian Mothers Consider Lipid-Based Nutrient Supplements Acceptable for Children throughout a 1-Year Intervention, but Deviation from User Recommendations Is Common.

BACKGROUND: Lipid-based nutrient supplements (LNSs) offer a vehicle to improve children's diets in low-income countries where complementary foods are typically deficient in essential nutrients. Sustained acceptability by the intended users is essential for achieving growth-promoting effects. OBJECTIVE: We aimed to determine the sustained acceptability of LNSs among 6- to 18-mo-old children in Malawi. METHODS: In the context of a trial testing the growth-promoting effect of different formulations and doses of LNSs, we delivered LNSs to the homes of the children biweekly according to the randomization protocol. We defined acceptability to include adherence to feeding recommendations and mothers' experiences of feeding LNSs to their child. We conducted brief interviews each week with the mothers. At 2 time points we conducted knowledge, attitudes, and practices (KAP) interviews. In addition, we conducted repeated in-depth interviews with a subset of mothers. RESULTS: Of the 1612 children who received the LNS intervention, we analyzed adherence data from 1478 (91.7%) children and KAP data at 2 time points (child's age of 12 and 18 mo) from 839 (52.1%) of the children. The mean ± SD overall adherence (proportion of days when the study child reportedly consumed LNSs considering only those weeks when the supplement had been successfully delivered to the home) was 92.4 ± 9.6%, and there was no difference between children receiving milk-containing or milk-free LNSs. There was also no increasing or decreasing trend over time in any of the groups. Sharing and deviation from other feeding recommendations were common. Maternal experiences were mostly very positive. CONCLUSIONS: The acceptability of LNS products was good and was sustained for 12 mo in this rural Malawian population. However, sharing of the products with family members and deviation from other feeding recommendations were frequent, which means that individually targeted children were likely to receive less than the intended dose of the LNS. This trial was registered at clinicaltrials.gov as NCT00945698.

The impact of lipid-based nutrient supplement provision to pregnant women on newborn size in rural Malawi: a randomized controlled trial.

BACKGROUND: Small birth size, often associated with insufficient maternal nutrition, contributes to a large share of global child undernutrition, morbidity, and mortality. We developed a small-quantity lipid-based nutrient supplement (SQ-LNS) to enrich the diets of pregnant women. OBJECTIVE: The objective was to test a hypothesis that home fortification of pregnant women's diets with SQ-LNS would increase birth size in an African community. DESIGN: We enrolled 1391 women with uncomplicated pregnancies (<20 gestational weeks) in a randomized controlled trial in Malawi. The women were provided with one daily iron-folic acid (IFA) capsule, one capsule containing multiple micronutrients (MMNs), or one 20-g sachet of SQ-LNS (LNS, containing 118 kcal, protein, carbohydrates, essential fatty acids, and 21 micronutrients). Primary outcomes were birth weight and newborn length. Secondary outcomes included newborn weight, head and arm circumference, and pregnancy duration. Analysis was by intention to treat. RESULTS: The mean ± SD birth weight and newborn length were 2948 ± 432, 2964 ± 460, and 3000 ± 447 g (P = 0.258) and 49.5 ± 2.4, 49.7 ± 2.2, and 49.9 ± 2.1 cm (P = 0.104) in the IFA, MMN, and LNS groups, respectively. For newborn weight-for-age, head circumference, and arm circumference, the point estimate for the mean was also highest in the LNS group, intermediate in the MMN group, and lowest in the IFA group, but except for midupper arm circumference (P = 0.024), the differences were not statistically significant. The prevalence of low birth weight (<2500 g) was 12.7%, 13.5%, and 12.1% (P = 0.856), respectively; newborn stunting (length-for-age z score < -2) was 19.2%, 14.0%, and 14.9% (P = 0.130), respectively; and newborn small head circumference (head circumference-for-age z score < -2) was 5.8%, 3.0%, and 3.1% (P = 0.099), respectively. The associations between the intervention and the outcomes were not modified by maternal parity, age, or nutritional status (P > 0.100). CONCLUSION: The study findings do not support a hypothesis that provision of SQ-LNS to all pregnant women would increase the mean birth size in rural Malawi. The trial was registered at clinicaltrials.gov as NCT01239693.