A Multi-Omics and Human Biomonitoring Approach to Assessing the Effectiveness of Fortified Balanced Energy-Protein Supplementation on Maternal and Newborn Health in Burkina Faso: A Study Protocol.

Fortified balanced energy-protein (BEP) supplementation is a promising intervention for improving maternal health, birth outcomes and infant growth in low- and middle-income countries. This nested biospecimen sub-study aimed to evaluate the physiological effect of multi-micronutrient-fortified BEP supplementation on pregnant and lactating women and their infants. Pregnant women (15-40 years) received either fortified BEP and iron-folic acid (IFA) (intervention) or IFA only (control) throughout pregnancy. The same women were concurrently randomized to receive either a fortified BEP supplement during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention) or the postnatal standard of care, which comprised IFA alone for 6 weeks postpartum (i.e., control). Biological specimens were collected at different timepoints. Multi-omics profiles will be characterized to assess the mediating effect of BEP supplementation on the different trial arms and its effect on maternal health, as well as birth and infant growth outcomes. The mediating effect of the exposome in the relationship between BEP supplementation and maternal health, birth outcomes and infant growth were characterized via biomonitoring markers of air pollution, mycotoxins and environmental contaminants. The results will provide holistic insight into the granular physiological effects of prenatal and postnatal BEP supplementation.

Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso.

BACKGROUND: Micronutrient-fortified balanced energy-protein (BEP) supplements are promising interventions to prevent intrauterine growth retardation in low- and middle-income countries. On the other hand, one concern with blanket prenatal supplementation programs using energy-dense supplements is that they could lead to more maternal and/or infant overweight. However, evidence is lacking on the potential effect of BEP on maternal and offspring body composition. This study evaluates the effects of micronutrient-fortified BEP supplementation during pregnancy on body composition of mothers and their newborns in rural Burkina Faso. METHODS AND FINDINGS: The MISAME-III study is an open label individually randomized controlled trial where pregnant women (n = 1,897) of gestational age <21 weeks received either a combination of micronutrient-fortified BEP and iron-folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control). The prenatal phase of the MISAME-III study was conducted between the first enrollment in October 2019 and the last delivery in August 2021. In a sub-study nested under the MISAME-III trial, we evaluated anthropometry and body composition in newborns who were born starting from 17 November 2020 (n: control = 368 and intervention = 352) and their mothers (n: control = 185 and intervention = 186). Primary study outcomes were newborn and maternal fat-free mass (FFMI) and fat-mass (FMI) indices. We used the deuterium dilution method to determine FFMI and FMI and %FFM and %FM of total body weight within 1 month postpartum. Our main analysis followed a modified intention-to-treat approach by analyzing all subjects with body composition data available. Univariable and multivariable linear regression models were fitted to compare the intervention and control arms, with adjusted models included baseline maternal age, height, arm fat index, hemoglobin concentration and primiparity, household size, wealth and food security indices, and newborn age (days). At study enrollment, the mean ± SD maternal age was 24.8 ± 6.13 years and body mass index (BMI) was 22.1 ± 3.02 kg/m2 with 7.05% of the mothers were underweight and 11.5% were overweight. Prenatal micronutrient-fortified BEP supplementation resulted in a significantly higher FFMI in mothers (MD (mean difference): 0.45; 95% CI (confidence interval): 0.05, 0.84; P = 0.026) and newborns (MD: 0.28; 95% CI: 0.06, 0.50; P = 0.012), whereas no statistically significant effects were found on FMI. The effect of micronutrient-fortified BEP on maternal FFMI was greater among mothers from food secure households and among those with a better nutritional status (BMI ≥21.0 kg/m2 or mid-upper arm circumference (MUAC) ≥23 cm). Key limitations of the study are the relatively high degree of missing data (approximately 18%), the lack of baseline maternal body composition values, and the lack of follow-up body composition measurements to evaluate any long-term effects. CONCLUSIONS: Micronutrient-fortified BEP supplementation during pregnancy can increase maternal and newborn FFMI, without significant effects on FMI. TRIAL REGISTRATION: ClinicalTrials.gov with identifier NCT03533712.

Correction: Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pmed.1004186.].

Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial.

BACKGROUND: Optimal nutrition is crucial during the critical period of the first 1,000 days from conception to 2 years after birth. Prenatal and postnatal supplementation of mothers with multimicronutrient-fortified balanced energy-protein (BEP) supplements is a potential nutritional intervention. However, evidence on the long-term effects of BEP supplementation on child growth is inconsistent. We evaluated the efficacy of daily fortified BEP supplementation during pregnancy and lactation on infant growth in rural Burkina Faso. METHODS AND FINDINGS: A 2 × 2 factorial individually randomized controlled trial (MISAME-III) was implemented in 6 health center catchment areas in Houndé district under the Hauts-Bassins region. From October 2019 to December 2020, 1,897 pregnant women aged 15 to 40 years with gestational age <21 completed weeks were enrolled. Women were randomly assigned to the prenatal intervention arms receiving either fortified BEP supplements and iron-folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control), which is the standard of care during pregnancy. The same women were concurrently randomized to receive either of the postnatal intervention, which comprised fortified BEP supplementation during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention), or the postnatal control, which comprised IFA alone for 6 weeks postpartum (i.e., control). Supplements were provided by trained village-based project workers under direct observation during daily home visits. We previously reported the effect of prenatal BEP supplementation on birth outcomes. The primary postnatal study outcome was length-for-age z-score (LAZ) at 6 months of age. Secondary outcomes were anthropometric indices of growth (weight-for length and weight-for-age z-scores, and arm and head circumferences) and nutritional status (prevalence rates of stunting, wasting, underweight, anemia, and hemoglobin concentration) at 6 months. Additionally, the longitudinal prevalence of common childhood morbidities, incidence of wasting, number of months of exclusive breastfeeding, and trajectories of anthropometric indices from birth to 12 months were evaluated. Prenatal BEP supplementation resulted in a significantly higher LAZ (0.11 standard deviation (SD), 95% confidence interval (CI) [0.01 to 0.21], p = 0.032) and lower stunting prevalence (-3.18 percentage points (pp), 95% CI [-5.86 to -0.51], p = 0.020) at 6 months of age, whereas the postnatal BEP supplementation did not have statistically significant effects on LAZ or stunting at 6 months. On the other hand, postnatal BEP supplementation did modestly improve the rate of monthly LAZ increment during the first 12 months postpartum (0.01 z-score/month, 95% CI [0.00 to 0.02], p = 0.030), whereas no differences in growth trajectories were detected between the prenatal study arms. Furthermore, except for the trend towards a lower prevalence of underweight found for the prenatal BEP intervention at 6 months (-2.74 pp, 95% CI [-5.65 to 1.17], p = 0.065), no other secondary outcome was significantly affected by the pre- or postnatal BEP supplementation. CONCLUSIONS: This study provides evidence that the benefits obtained from prenatal BEP supplementation on size at birth are sustained during infancy in terms of linear growth. Maternal BEP supplementation during lactation may lead to a slightly better linear growth towards the second half of infancy. These findings suggest that BEP supplementation during pregnancy can contribute to the efforts to reduce the high burden of child growth faltering in low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03533712.

Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: A Randomized Controlled Efficacy Trial among Pregnant Women in Rural Burkina Faso.

BACKGROUND: Anemia and suboptimal gestational weight gain (GWG) are associated with adverse maternal and birth outcomes. Limited research indicates that balanced energy-protein (BEP) supplements reduce the incidence of inadequate GWG. OBJECTIVES: We assessed the efficacy of a micronutrient-fortified BEP supplement on the secondary outcomes of anemia, GWG, GWG rate, and GWG in relation to the Institute of Medicine (IOM)'s recommendations, as compared with an iron-folic acid (IFA) tablet. METHODS: We conducted a randomized controlled trial in Burkina Faso, among pregnant women (15-40 y old) enrolled at <21 weeks of gestation. Women received either BEP and IFA (intervention) or IFA (control). Hemoglobin (g/dL) concentrations were measured at baseline and the third antenatal care visit (ANC), whereas maternal weight was measured at baseline and all subsequent ∼7-weekly ANCs. GWG (kg) was calculated as a woman's last weight measurement (at ∼36 weeks of gestation) minus weight at enrollment, whereas GWG rate (kg/wk) was GWG divided by the time between the first and last weight measurements. GWG adequacy (%) was computed as GWG divided by the IOM's recommendation. Binary outcomes included severely inadequate, inadequate, and excessive GWG. Statistical analyses followed the intention-to-treat principle. Linear regression and probability models were fitted for the continuous and binary outcomes, respectively, adjusting for baseline measurements. RESULTS: Women in the BEP group tended to have higher, but nonsignificantly different, GWG (0.28 kg; 95% CI: -0.05, 0.58 kg; P = 0.099). Furthermore, there were no significant differences in prenatal anemia prevalence, GWG rate, GWG adequacy, or incidence of inadequate or excessive GWG. Findings were robust to model adjustments and complete case and per protocol analyses. CONCLUSIONS: This trial does not provide evidence that fortified BEP supplementation reduces maternal anemia or increases GWG, as compared with IFA. In conjunction with the small, but positive, effects of maternal BEP supplementation on birth outcomes, our findings warrant the investigation of additional biochemical and postnatal outcomes.This trial was registered at clinicaltrials.gov as NCT03533712.

Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial.

BACKGROUND: Providing balanced energy-protein (BEP) supplements is a promising intervention to improve birth outcomes in low- and middle-income countries (LMICs); however, evidence is limited. We aimed to assess the efficacy of fortified BEP supplementation during pregnancy to improve birth outcomes, as compared to iron-folic acid (IFA) tablets, the standard of care. METHODS AND FINDINGS: We conducted an individually randomized controlled efficacy trial (MIcronutriments pour la SAnté de la Mère et de l'Enfant [MISAME]-III) in 6 health center catchment areas in rural Burkina Faso. Pregnant women, aged 15 to 40 years with gestational age (GA) <21 completed weeks, were randomly assigned to receive either fortified BEP supplements and IFA (intervention) or IFA (control). Supplements were provided during home visits, and intake was supervised on a daily basis by trained village-based project workers. The primary outcome was prevalence of small-for-gestational age (SGA) and secondary outcomes included large-for-gestational age (LGA), low birth weight (LBW), preterm birth (PTB), gestational duration, birth weight, birth length, Rohrer's ponderal index, head circumference, thoracic circumference, arm circumference, fetal loss, and stillbirth. Statistical analyses followed the intention-to-treat (ITT) principle. From October 2019 to December 2020, 1,897 pregnant women were randomized (960 control and 937 intervention). The last child was born in August 2021, and birth anthropometry was analyzed from 1,708 pregnancies (872 control and 836 intervention). A total of 22 women were lost to follow-up in the control group and 27 women in the intervention group. BEP supplementation led to a mean 3.1 percentage points (pp) reduction in SGA with a 95% confidence interval (CI) of -7.39 to 1.16 (P = 0.151), indicating a wide range of plausible true treatment efficacy. Adjusting for prognostic factors of SGA, and conducting complete cases (1,659/1,708, 97%) and per-protocol analysis among women with an observed BEP adherence ≥75% (1,481/1,708, 87%), did not change the results. The intervention significantly improved the duration of gestation (+0.20 weeks, 95% CI 0.05 to 0.36, P = 0.010), birth weight (50.1 g, 8.11 to 92.0, P = 0.019), birth length (0.20 cm, 0.01 to 0.40, P = 0.044), thoracic circumference (0.20 cm, 0.04 to 0.37, P = 0.016), arm circumference (0.86 mm, 0.11 to 1.62, P = 0.025), and decreased LBW prevalence (-3.95 pp, -6.83 to -1.06, P = 0.007) as secondary outcomes measures. No differences in serious adverse events [SAEs; fetal loss (21 control and 26 intervention) and stillbirth (16 control and 17 intervention)] between the study groups were found. Key limitations are the nonblinded administration of supplements and the lack of information on other prognostic factors (e.g., infection, inflammation, stress, and physical activity) to determine to which extent these might have influenced the effect on nutrient availability and birth outcomes. CONCLUSIONS: The MISAME-III trial did not provide evidence that fortified BEP supplementation is efficacious in reducing SGA prevalence. However, the intervention had a small positive effect on other birth outcomes. Additional maternal and biochemical outcomes need to be investigated to provide further evidence on the overall clinical relevance of BEP supplementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03533712.

Seasonality and Day-to-Day Variability of Dietary Diversity: Longitudinal Study of Pregnant Women Enrolled in a Randomized Controlled Efficacy Trial in Rural Burkina Faso.

BACKGROUND: Panel data indicate that nonpregnant women's dietary diversity fluctuates across climatic seasons in low- and middle-income countries. The natural day-to-day variability in food group consumption during gestation is unknown. OBJECTIVES: A longitudinal study was conducted among pregnant women enrolled in the Micronutriments pour la Santé de la Mère et de l'Enfant study 3 randomized controlled efficacy trial [i.e., daily fortified balanced energy-protein supplement and an iron-folic acid (IFA) tablet compared with an IFA tablet only] to investigate the number of 24-hour recalls required to estimate usual prenatal food group (FG) diversity and the seasonality of pregnant women's dietary diversity in Houndé, Burkina Faso. METHODS: FG consumption was assessed twice weekly by qualitative, list-based, 24-hour recalls among 1757 pregnant women (892 control, 865 intervention). The number of days needed to estimate a woman's usual prenatal 10-point FG diversity score was calculated using the within-subject coefficient of variation. Regression models, including truncated Fourier series, were fitted to assess seasonal variations in the FG diversity score and the probability of reaching Minimum Dietary Diversity for Women (MDD-W; i.e., ≥5 FGs). RESULTS: The monthly mean FG scores (<5 FGs) and MDD-W prevalence (<45%) were low. Five list-based recalls allowed observed FG diversity to lie within 15% of the true mean in 90% of the estimations (mean ± SD, 40.4 ± 20.7 recalls per woman). Both the FG diversity score and prevalence achieving MDD-W showed responsiveness to seasonal variations, with peaks at the end of the dry season (i.e., April or May) and troughs in the rainy season (i.e., August). CONCLUSIONS: Five list-based recalls are sufficient to estimate usual FG diversity during gestation, although intra-annual seasonal patterns did modestly affect the FG diversity score and MDD-W prevalence. Thus, timing of repeated dietary surveys is critical to ensure nonbiased inferences of change and trends in Burkina Faso. This trial was registered at clinicaltrials.gov as NCT03533712.

Fortified Balanced Energy-Protein Supplements Increase Nutrient Adequacy without Displacing Food Intake in Pregnant Women in Rural Burkina Faso.

BACKGROUND: In many low- and middle-income countries, the prevalence of energy and nutrient deficiencies is high among pregnant women. Balanced energy-protein (BEP) supplements are a promising strategy to cover nutritional requirements during pregnancy and improve birth outcomes. However, the displacement of nutrient-dense foods by BEP might attenuate the efficacy of supplementation. OBJECTIVE: This cross-sectional study of participants in a randomized controlled trial evaluated the difference in energy and macro- and micronutrient intakes, food groups, and nutrient adequacy between a control and intervention group receiving either a daily iron-folic acid (IFA) tablet or IFA and BEP supplement during pregnancy, respectively. METHODS: We collected a single multiple-pass 24-h recall from 470 pregnant women from the MIcronutriments pour la SAnté de la Mère et de l'Enfant (MISAME) III study that investigates the efficacy of BEP supplementation on birth outcomes and infant growth. Dietary intake (median and IQR) and nutrient adequacy were assessed using individual recipes and preparation methods of mixed dishes for each participant. Linear regression models were fitted to compare energy and nutrient intakes. RESULTS: Dietary energy, and macro- and micronutrient intakes were significantly higher among women in the intervention group when including BEP [2329 kcal/d (1855, 3008 kcal/d) compared with 1942 kcal/d (1575, 2405 kcal/d) in the control group (all P < 0.001)]. The difference in median energy intake (448 kcal/d; 95% CI: 291, 605 kcal/d) was approximately equivalent to a daily dose of the BEP supplement (393 kcal). Nutrient adequacy ratios for both groups were low for all micronutrients (between 0.02 and 0.66), when excluding BEP (except iron and folic acid, due to standard supplemental doses) from analysis. However, nutrient intakes increased to the Estimated Average Requirement for pregnant women when including BEP supplements. CONCLUSIONS: BEP supplementation increases energy and macro- and micronutrient intakes among pregnant women and fills nutrient gaps without displacing food intake. This trial was registered at clinicaltrials.gov as NCT03533712 (https://clinicaltrials.gov/ct2/show/NCT03533712).

Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial.

INTRODUCTION: Adequate nutrition during pregnancy is crucial to both mother and child. Maternal malnutrition can be the cause of stillbirth or lead to poor birth outcomes such as preterm delivery and small-for-gestational-age newborns. There is a probable positive effect of providing pregnant women a balanced energy-protein (BEP) food supplement, but more evidence is needed. The MIcronutriments pour la SAnté de la Mère et de l'Enfant (MISAME) III project aims to improve birth outcomes and infant growth by testing a BEP supplement during pregnancy and lactation in rural Burkina Faso. This paper describes the study protocol. METHODS AND ANALYSIS: MISAME-III is a four-arm individually randomised efficacy trial implemented in six rural health centre catchments areas in the district of Houndé. Eligible pregnant women, aged between 15 and 40 years old and living in the study areas, will be enrolled. Women will be randomly assigned to one of the four study groups: (1) prenatal intervention only, (2) postnatal intervention only, (3) prenatal and postnatal intervention or (4) no prenatal or postnatal intervention. The intervention group will receive the BEP supplement and iron/folic acid (IFA) tablets, while the control group will only receive the IFA tablets following the national health protocol. Consumption will be supervised by trained village women on a daily basis by means of home visits. The primary outcomes are small-for-gestational age at birth and length-for-age z-score at 6 months of age. Secondary outcomes will be measured at birth and during the first 6 months of the infants' life. Women will be enrolled from October 2019 until the total sample size is reached. ETHICS AND DISSEMINATION: MISAME-III has been reviewed and approved by the University Hospital of Ghent and the ethics committee of Centre Muraz, Burkina Faso. Informed consent will be obtained. Results will be published in relevant journals and shared with other researchers and public health institutions. TRIAL REGISTRATION NUMBER: NCT03533712.

Home consumption of two fortified balanced energy protein supplements by pregnant women in Burkina Faso.

Balanced energy protein (BEP) supplementation for pregnant and lactating women in low- and middle-income countries is a promising strategy to improve birth outcomes and child growth. The objective of this study was to assess and compare the acceptability of new formulations of two fortified BEP supplements, a lipid-based peanut paste and a vanilla biscuit, among 80 pregnant women in rural Burkina Faso, prior to an efficacy trial. A 10-week individually randomized cross-over study was designed, in which women received a weekly supply of each supplement for 4 weeks, and a daily choice between the supplements in the last 2 weeks. Questionnaires to assess daily consumption and supplement acceptability (n = 80) and home observations (n = 20) were combined with focus group discussions (n = 6) and in-depth interviews with women (n = 80) and stakeholders (n = 24). Results showed that the two supplements were well accepted. Quantitative findings indicated high compliance (>99.6%) and high overall appreciation (Likert score >6 out of 7) of both supplements. The assessment of preferred choice in Weeks 9 and 10 indicated a slight preference for the vanilla biscuit. Qualitative findings indicated that perceived health benefits, support from household members and educational messages from health professionals were important drivers for acceptance and compliance. Sharing was not often reported but was identified during interviews as a possible risk. We recommend that future studies use a combination of methods to identify appropriate food supplements and context-specific factors that influence acceptability, compliance and subsequent impact of nutritious food supplements.

Acceptability of 12 fortified balanced energy protein supplements - Insights from Burkina Faso.

Poor maternal nutrition contributes to poor birth outcomes, including low birth weight and small for gestational age births. Fortified balanced energy protein (BEP) supplements may be beneficial, although evidence is limited. This mixed method study, conducted among pregnant women in Burkina Faso, is part of a larger clinical trial that seeks to understand the impact of fortified BEP supplements on pregnancy outcomes and child growth. The formative research reported here, a single-meal rapid assessment of 12 product formulations, sought to understand product preferences for provision of BEP supplements and contextual factors that might affect product acceptability and use. Results indicate a preference for products perceived as sweet rather than salty/savoury and for products perceived as familiar, as well as a sensitivity to product odours. Women expressed a willingness and intention to use the products even if they did not like them, because of the health benefits for their babies. Data also indicate that household food sharing practices may impact supplement use, although most women denied any intention to share the products. Sharing behaviour should therefore be monitored, and strategies to avoid sharing should be developed during the succeeding parts of the research.

Modelling the effect of a mass radio campaign on child mortality using facility utilisation data and the Lives Saved Tool (LiST): findings from a cluster randomised trial in Burkina Faso.

BACKGROUND: A cluster randomised trial (CRT) in Burkina Faso was the first to demonstrate that a radio campaign increased health-seeking behaviours, specifically antenatal care attendance, health facility deliveries and primary care consultations for children under 5 years. METHODS: Under-five consultation data by diagnosis was obtained from primary health facilities in trial clusters, from January 2011 to December 2014. Interrupted time-series analyses were conducted to assess the intervention effect by time period on under-five consultations for separate diagnosis categories that were targeted by the media campaign. The Lives Saved Tool was used to estimate the number of under-five lives saved and the per cent reduction in child mortality that might have resulted from increased health service utilisation. Scenarios were generated to estimate the effect of the intervention in the CRT study areas, as well as a national scale-up in Burkina Faso and future scale-up scenarios for national media campaigns in five African countries from 2018 to 2020. RESULTS: Consultations for malaria symptoms increased by 56% in the first year (95% CI 30% to 88%; p<0.001) of the campaign, 37% in the second year (95% CI 12% to 69%; p=0.003) and 35% in the third year (95% CI 9% to 67%; p=0.006) relative to the increase in the control arm. Consultations for lower respiratory infections increased by 39% in the first year of the campaign (95% CI 22% to 58%; p<0.001), 25% in the second (95% CI 5% to 49%; p=0.010) and 11% in the third year (95% CI -20% to 54%; p=0.525). Diarrhoea consultations increased by 73% in the first year (95% CI 42% to 110%; p<0.001), 60% in the second (95% CI 12% to 129%; p=0.010) and 107% in the third year (95% CI 43% to 200%; p<0.001). Consultations for other diagnoses that were not targeted by the radio campaign did not differ between intervention and control arms. The estimated reduction in under-five mortality attributable to the radio intervention was 9.7% in the first year (uncertainty range: 5.1%-15.1%), 5.7% in the second year and 5.5% in the third year. The estimated number of under-five lives saved in the intervention zones during the trial was 2967 (range: 1110-5741). If scaled up nationally, the estimated reduction in under-five mortality would have been similar (9.2% in year 1, 5.6% in year 2 and 5.5% in year 3), equating to 14 888 under-five lives saved (range: 4832-30 432). The estimated number of lives that could be saved by implementing national media campaigns in other low-income settings ranged from 7205 in Burundi to 21 443 in Mozambique. CONCLUSION: Evidence from a CRT shows that a child health radio campaign increased under-five consultations at primary health centres for malaria, pneumonia and diarrhoea (the leading causes of postneonatal child mortality in Burkina Faso) and resulted in an estimated 7.1% average reduction in under-five mortality per year. These findings suggest important reductions in under-five mortality can be achieved by mass media alone, particularly when conducted at national scale.

Cost-effectiveness and economies of scale of a mass radio campaign to promote household life-saving practices in Burkina Faso.

INTRODUCTION: Child health promotion through mass media has not been rigorously evaluated for cost-effectiveness in low-income and middle-income countries. We assessed the cost-effectiveness of a mass radio campaign on health-seeking behaviours for child survival within a trial in Burkina Faso and at national scale. METHODS: We collected provider cost data prospectively alongside a 35-month cluster randomised trial in rural Burkina Faso in 2012-2015. Out-of-pocket costs of care-seeking were estimated through a household survey. We modelled intervention effects on child survival based on increased care-seeking and estimated the intervention's incremental cost-effectiveness ratio (ICER) in terms of the cost per disability-adjusted life year (DALY) averted versus current practice. Model uncertainty was gauged using one-way and probabilistic sensitivity analyses. We projected the ICER of national-scale implementation in five sub-Saharan countries with differing media structures. All costs are in 2015 USD. RESULTS: The provider cost of the campaign was $7 749 128 ($9 146 101 including household costs). The campaign broadcast radio spots 74 480 times and 4610 2-hour shows through seven local radio stations, reaching approximately 2.4 million people including 620 000 direct beneficiaries (pregnant women and children under five). It resulted in an average estimated 24% increase in care-seeking for children under five and a 7% reduction in child mortality per year. The ICER was estimated at $94 ($111 including household costs (95% CI -38 to 320)). The projected provider cost per DALY averted of a national level campaign in Burkina Faso, Burundi, Malawi, Mozambique and Niger in 2018-2020, varied between $7 in Malawi to $27 in Burundi. CONCLUSION: This study suggests that mass-media campaigns can be very cost-effective in improving child survival in areas with high media penetration and can potentially benefit from considerable economies of scale. TRIAL REGISTRATION NUMBER: NCT01517230; Results.

Effect of a mass radio campaign on family behaviours and child survival in Burkina Faso: a repeated cross-sectional, cluster-randomised trial.

BACKGROUND: Media campaigns can potentially reach a large audience at relatively low cost but, to our knowledge, no randomised controlled trials have assessed their effect on a health outcome in a low-income country. We aimed to assess the effect of a radio campaign addressing family behaviours on all-cause post-neonatal under-5 child mortality in rural Burkina Faso. METHODS: In this repeated cross-sectional, cluster randomised trial, clusters (distinct geographical areas in rural Burkina Faso with at least 40 000 inhabitants) were selected by Development Media International based on their high radio listenership (>60% of women listening to the radio in the past week) and minimum distances between radio stations to exclude population-level contamination. Clusters were randomly allocated to receive the intervention (a comprehensive radio campaign) or control group (no radio media campaign). Household surveys were performed at baseline (from December, 2011, to February, 2012), midline (in November, 2013, and after 20 months of campaigning), and endline (from November, 2014, to March, 2015, after 32 months of campaigning). Primary analyses were done on an intention-to-treat basis, based on cluster-level summaries and adjusted for imbalances between groups at baseline. The primary outcome was all-cause post-neonatal under-5 child mortality. The trial was designed to detect a 20% reduction in the primary outcome with a power of 80%. Routine data from health facilities were also analysed for evidence of changes in use and these data had high statistical power. The indicators measured were new antenatal care attendances, facility deliveries, and under-5 consultations. This trial is registered with ClinicalTrial.gov, number NCT01517230. FINDINGS: The intervention ran from March, 2012, to January, 2015. 14 clusters were selected and randomly assigned to the intervention group (n=7) or the control group (n=7). The average number of villages included per cluster was 34 in the control group and 29 in the intervention group. 2269 (82%) of 2784 women in the intervention group reported recognising the campaign's radio spots at endline. Post-neonatal under-5 child mortality decreased from 93·3 to 58·5 per 1000 livebirths in the control group and from 125·1 to 85·1 per 1000 livebirths in the intervention group. There was no evidence of an intervention effect (risk ratio 1·00, 95% CI 0·82-1·22; p>0·999). In the first year of the intervention, under-5 consultations increased from 68 681 to 83 022 in the control group and from 79 852 to 111 758 in the intervention group. The intervention effect using interrupted time-series analysis was 35% (95% CI 20-51; p<0·0001). New antenatal care attendances decreased from 13 129 to 12 997 in the control group and increased from 19 658 to 20 202 in the intervention group in the first year (intervention effect 6%, 95% CI 2-10; p=0·004). Deliveries in health facilities decreased from 10 598 to 10 533 in the control group and increased from 12 155 to 12 902 in the intervention group in the first year (intervention effect 7%, 95% CI 2-11; p=0·004). INTERPRETATION: A comprehensive radio campaign had no detectable effect on child mortality. Substantial decreases in child mortality were observed in both groups over the intervention period, reducing our ability to detect an effect. This, nevertheless, represents the first randomised controlled trial to show that mass media alone can change health-seeking behaviours. FUNDING: Wellcome Trust and Planet Wheeler Foundation.

Switching the poles in sexual and reproductive health research: implementing a research capacity-strengthening network in West and North Africa.

Health research capacities have been improved in Africa but still remain weak as compared to other regions of the World. To strengthen these research capacities, international collaboration and networking for knowledge and capacity transfer are needed. In this commentary, we present the Network for Scientific Support in the field of Sexual and Reproductive Health in West and North Africa, its priority research topics and discuss its implementation process. Established in January 2014, the Network aims at generating human rights and gender-based research fully carried out and driven by South based institutions. It is composed of 12 institutions including the Institute of Tropical Medicine of Antwerp (Belgium) and 11 institutions from eight Francophone West and North African countries. The key areas of interest of this network are health policies analysis and health system research in family planning, HIV prevention among vulnerable groups, quality of care and breast cancers. Since it started, seventeen research proposals based on locally relevant research questions have been developed. Among the seventeen proposals, eleven have been implemented. Several research institutions enhanced linkages with local representations of international partners such as UNFPA. The network is committed to strengthening methodological research capacities and soft skills such as fundraising, advocacy and leadership. Such competencies are strongly needed for developing an effective South-based leadership in Sexual and Reproductive Health research, and for achieving the Sustainable Development Goals.

Behavior Change After 20 Months of a Radio Campaign Addressing Key Lifesaving Family Behaviors for Child Survival: Midline Results From a Cluster Randomized Trial in Rural Burkina Faso.

BACKGROUND: In Burkina Faso, a comprehensive 35-month radio campaign addressed key, multiple family behaviors for improving under-5 child survival and was evaluated using a repeated cross-sectional, cluster randomized design. The primary outcome of the trial was postneonatal under-5 child mortality. This paper reports on behavior change achieved at midline. METHOD: Fourteen community radio stations in 14 geographic areas were selected based on their high listenership. Seven areas were randomly allocated to receive the intervention while the other 7 areas served as controls. The campaign was launched in March 2012. Cross-sectional surveys of about 5,000 mothers of under-5 children, living in villages close to the radio stations, were conducted at baseline (from December 2011 to February 2012) and at midline (in November 2013), after 20 months of campaigning. Statistical analyses were based on cluster-level summaries using a difference-in-difference (DiD) approach and adjusted for imbalances between arms at baseline. In addition, routine health facility data were analyzed for evidence of changes in health facility utilization. RESULTS: At midline, 75% of women in the intervention arm reported recognizing radio spots from the campaign. There was some evidence of the campaign having positive effects on care seeking for diarrhea (adjusted DiD, 17.5 percentage points; 95% confidence interval [CI], 2.5 to 32.5; P= .03), antibiotic treatment for fast/difficult breathing (adjusted DiD, 29.6 percentage points; 95% CI, 3.5 to 55.7; P= .03), and saving money during pregnancy (adjusted DiD, 12.8 percentage points; 95% CI, 1.4 to 24.2; P= .03). For other target behaviors, there was little or no evidence of an impact of the campaign after adjustment for baseline imbalances and confounding factors. There was weak evidence of a positive correlation between the intensity of broadcasting of messages and reported changes in target behaviors. Routine health facility data were consistent with a greater increase in the intervention arm than in the control arm in all-cause under-5 consultations (33% versus 17%, respectively), but the difference was not statistically significant (P= .40). CONCLUSION: The radio campaign reached a high proportion of the primary target population, but the evidence for an impact on key child survival-related behaviors at midline was mixed.

Can mass media interventions reduce child mortality?

Many people recognise that mass media is important in promoting public health but there have been few attempts to measure how important. An ongoing trial in Burkina Faso (ClinicalTrials.gov, NCT01517230) is an attempt to bring together the very different worlds of mass media and epidemiology: to measure rigorously, using a cluster-randomised design, how many lives mass media can save in a low-income country, and at what cost. Application of the Lives Saved Tool predicts that saturation-based media campaigns could reduce child mortality by 10-20%, at a cost per disability-adjusted life-year that is as low as any existing health intervention. In this Viewpoint we explain the scientific reasoning behind the trial, while stressing the importance of the media methodology used.

Challenges of scaling up and of knowledge transfer in an action research project in Burkina Faso to exempt the worst-off from health care user fees.

BACKGROUND: Systems to exempt the indigent from user fees have been put in place to prevent the worst-off from being excluded from health care services for lack of funds. Yet the implementation of these mechanisms is as rare as the operational research on this topic. This article analyzes an action research project aimed at finding an appropriate solution to make health care accessible to the indigent in a rural district of Burkina Faso. RESEARCH: This action research project was initiated in 2007 to study the feasibility and effectiveness of a community-based, participative and financially sustainable process for exempting the indigent from user fees. A interdisciplinary team of researchers from Burkina Faso and Canada was mobilized to document this action research project. RESULTS AND KNOWLEDGE SHARING: The action process was very well received. Indigent selection was effective and strengthened local solidarity, but coverage was reduced by the lack of local financial resources. Furthermore, the indigent have many other needs that cannot be addressed by exemption from user fees. Several knowledge transfer strategies were implemented to share research findings with residents and with local and national decision-makers. PARTNERSHIP ACHIEVEMENTS AND DIFFICULTIES: Using a mixed and interdisciplinary research approach was critical to grasping the complexity of this community-based process. The adoption of the process and the partnership with local decision-makers were very effective. Therefore, at the instigation of an NGO, four other districts in Burkina Faso and Niger reproduced this experiment. However, national decision-makers showed no interest in this action and still seem unconcerned about finding solutions that promote access to health care for the indigent. LESSONS LEARNED: The lessons learned with regard to knowledge transfer and partnerships between researchers and associated decision-makers are: i) involve potential users of the research results from the research planning stage; ii) establish an ongoing partnership between researchers and users; iii) ensure that users can participate in certain research activities; iv) use a variety of strategies to disseminate results; and v) involve users in dissemination activities.

Targeting the worst-off for free health care: a process evaluation in Burkina Faso.

Effective mechanisms to exempt the indigent from user fees at health care facilities are rare in Africa. A State-led intervention (2004-2005) and two action research projects (2007-2010) were implemented in a health district in Burkina Faso to exempt the indigent from user fees. This article presents the results of the process evaluation of these three interventions. Individual and group interviews were organized with the key stakeholders (health staff, community members) to document the strengths and weaknesses of key components of the interventions (relevance and uptake of the intervention, worst-off selection and information, financial arrangements). Data was subjected to content analysis and thematic analysis. The results show that all three intervention processes can be improved. Community-based targeting was better accepted by the stakeholders than was the State-led intervention. The strengths of the community-based approach were in clearly defining the selection criteria, informing the waiver beneficiaries, using a participative process and using endogenous funding. A weakness was that using endogenous funding led to restrictive selection by the community. The community-based approach appears to be the most effective, but it needs to be improved and retested to generate more knowledge before scaling up.

Low coverage but few inclusion errors in Burkina Faso: a community-based targeting approach to exempt the indigent from user fees.

BACKGROUND: User fees were generalized in Burkina Faso in the 1990s. At the time of their implementation, it was envisioned that measures would be instituted to exempt the poor from paying these fees. However, in practice, the identification of indigents is ineffective, and so they do not have access to care. Thus, a community-based process for selecting indigents for user fees exemption was tested in a district. In each of the 124 villages in the catchment areas of ten health centres, village committees proposed lists of indigents that were then validated by the health centres' management committees. The objective of this study is to evaluate the effectiveness of this community-based selection. METHODS: An indigent-selection process is judged effective if it minimizes inclusion biases and exclusion biases. The study compares the levels of poverty and of vulnerability of indigents selected by the management committees (n = 184) with: 1) indigents selected in the villages but not retained by these committees (n = 48); ii) indigents selected by the health centre nurses (n = 82); and iii) a sample of the rural population (n = 5,900). RESULTS: The households in which the three groups of indigents lived appeared to be more vulnerable and poorer than the reference rural households. Indigents selected by the management committees and the nurses were very comparable in terms of levels of vulnerability, but the former were more vulnerable socially. The majority of indigents proposed by the village committees who lived in extremely poor households were retained by the management committees. Only 0.36% of the population living below the poverty threshold and less than 1% of the extremely poor population were selected. CONCLUSIONS: The community-based process minimized inclusion biases, as the people selected were poorer and more vulnerable than the rest of the population. However, there were significant exclusion biases; the selection was very restrictive because the exemption had to be endogenously funded.