ObjectiveTo determine whether an intervention to involve the male partners of pregnant women in maternity care influenced care-seeking, healthy breastfeeding and contraceptive practices after childbirth in urban Burkina Faso.MethodsIn a non-blinded, multicentre, parallel-group, superiority trial, 1144 women were assigned by simple randomization to two study arms: 583 entered the intervention arm and 561 entered the control arm. All women were cohabiting with a male partner and had a low-risk pregnancy. Recruitment took place at 20 to 36 weeks’ gestation at five primary health centres in Bobo-Dioulasso. The intervention comprised three educational sessions: (i) an interactive group session during pregnancy with male partners only, to discuss their role; (ii) a counselling session during pregnancy for individual couples; and (iii) a postnatal couple counselling session. The control group received routine care only. We followed up participants at 3 and 8 months postpartum.FindingsThe follow-up rate was over 96% at both times. In the intervention arm, 74% (432/583) of couples or men attended at least two study sessions. Attendance at two or more outpatient postnatal care consultations was more frequent in the intervention than the control group (risk difference, RD: 11.7%; 95% confidence interval, CI: 6.0 to 17.5), as was exclusive breastfeeding 3 months postpartum (RD: 11.4%; 95% CI: 5.8 to 17.2) and effective modern contraception use 8 months postpartum (RD: 6.4%; 95% CI: 0.5 to 12.3).ConclusionInvolving men as supportive partners in maternity care was associated with better adherence to recommended healthy practices after childbirth.

SummaryBackgroundMedia 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.MethodsIn 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.FindingsThe 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 ye...

The radio campaign reached a high proportion of mothers, but the impact on self-reported behaviors at midline was mixed. Some reported episodic behaviors such as care seeking for diarrhea and obtaining treatment for fast/difficult breathing improved more in intervention than control areas, but there was little or no difference between areas in reported habitual behaviors, such as exclusive breastfeeding, complementary feeding, hand washing with soap, and use of bed nets.

Summary Background The benefits of exclusive breastfeeding on mortality, health, and development of children have been well documented. In Burkina Faso, the Alive & Thrive initiative combined interpersonal communication and community mobilisation activities with the aim of improving knowledge, beliefs, skills, and, ultimately, breastfeeding outcomes. The objective of this study was to determine the effect of the Alive & Thrive initiative on exclusive breastfeeding in Boucle du Mouhoun, Burkina Faso. Methods We did a cluster-randomised trial with data collected with two independent, population-representative, cross-sectional surveys: a baseline survey done before the start of the initiative implementation and an endline survey done 2 years later. Rural villages in Boucle du Mouhoun, Burkina Faso, were randomly allocated by use of computer generated pseudo-random numbers, and women were eligible for participation if they had a livebirth in the 12 months preceding the survey and resided in a village selected for the study. The primary outcome was exclusive breastfeeding among infants younger than 6 months. Masking was not possible for the intervention implementation. All women who participated in the trial were included in the analysis population. The trial is registered with ClinicalTrials.gov , number NCT02435524 . Findings Between June 2 and July 28, 2015, 2288 mothers participated in the baseline survey and between June 12 and July 25, 2017, 2253 mothers participated in the endline survey. At endline, there was a risk difference of 38·9% (95% CI 32·2–45·6, p<0·001) between the reported prevalence of exclusive breastfeeding in the intervention group and that of the control group. Interpretation A multidimensional intervention deliverable at scale in a low-income setting resulted in substantial increases in mothers' optimal breastfeeding knowledge and beliefs and in reported exclusive breastfeeding practices. However, it is possible that the findings might have been influenced by social desirability bias. Funding Bill & Melinda Gates Foundation, London School of Hygiene & Tropical Medicine.

BackgroundA 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.MethodsUnder-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.ResultsConsultations 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.ConclusionEvidence 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.

Background Long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) target night-time indoor biting mosquitoes and effectively reduce malaria transmission in rural settings across Africa, but additional vector control tools are needed to interrupt transmission. Attractive targeted sugar baits (ATSBs) attract and kill mosquitoes, including those biting outdoors. Deployment of ATSBs incorporating the insecticide dinotefuran was associated with major reductions in mosquito density and longevity in Mali. The impact of this promising intervention on malaria transmission and morbidity now needs to be determined in a range of transmission settings. Methods/design We will conduct three similar stand-alone, open-label, two-arm, cluster-randomized, controlled trials (cRCTs) in Mali, Kenya, and Zambia to determine the impact of ATSB + universal vector control versus universal vector control alone on clinical malaria. The trials will use a “fried-egg” design, with primary outcomes measured in the core area of each cluster to reduce spill-over effects. All household structures in the ATSB clusters will receive two ATSBs, but the impact will be measured in the core of clusters. Restricted randomization will be used. The primary outcome is clinical malaria incidence among children aged 5–14 years in Mali and 1–14 years in Kenya and Zambia. A key secondary outcome is malaria parasite prevalence across all ages. The trials will include 76 clusters (38 per arm) in Mali and 70 (35 per arm) in each of Kenya and Zambia. The trials are powered to detect a 30% reduction in clinical malaria, requiring a total of 3850 person-years of follow-up in Mali, 1260 person-years in Kenya, and 1610 person-years in Zambia. These sample sizes will be ascertained using two seasonal 8-month cohorts in Mali and two 6-month seasonal cohorts in Zambia. In Kenya, which has year-round transmission, four 6-month cohorts will be used (total 24 months of follow-up). The design allows for one interim analysis in Mali and Zambia and two in Kenya. Discussion Strengths of the design include the use of multiple study sites with different transmission patterns and a range of vectors to improve external validity, a large number of clusters within each trial site, restricted randomization, between-cluster separation to minimize contamination between study arms, and an adaptive trial design. Noted threats to internal validity include open-label design, risk of contamination between study arms, risk of imbalance of covariates across study arms, variation in durability of ATSB stations, and potential disruption resulting from the COVID-19 pandemic. Trial registration Zambia: ClinicalTrials.gov NCT04800055. Registered on March 15, 2021 Mali: ClinicalTrials.gov NCT04149119. Registered on November 4, 2019 Kenya: ClinicalTrials.gov NCT05219565. Registered on February 2, 2022

Background The Integrated eDiagnosis Approach (IeDA), centred on an electronic Clinical Decision Support System (eCDSS) developed in line with national Integrated Management of Childhood Illness (IMCI) guidelines, was implemented in primary health facilities of two regions of Burkina Faso. An evaluation was performed using a stepped-wedge cluster randomised design with the aim of determining whether the IeDA intervention increased Health Care Workers’ (HCW) adherence to the IMCI guidelines. Methods Ten randomly selected facilities per district were visited at each step by two trained nurses: One observed under-five consultations and the second conducted a repeat consultation. The primary outcomes were: overall adherence to clinical assessment tasks; overall correct classification ignoring the severity of the classifications; and overall correct prescription according to HCWs’ classifications. Statistical comparisons between trial arms were performed on cluster/step-level summaries. Results On average, 54 and 79% of clinical assessment tasks were observed to be completed by HCWs in the control and intervention districts respectively (cluster-level mean difference = 29.9%; P-value = 0.002). The proportion of children for whom the validation nurses and the HCWs recorded the same classifications (ignoring the severity) was 73 and 79% in the control and intervention districts respectively (cluster-level mean difference = 10.1%; P-value = 0.004). The proportion of children who received correct prescriptions in accordance with HCWs’ classifications were similar across arms, 78% in the control arm and 77% in the intervention arm (cluster-level mean difference = − 1.1%; P-value = 0.788). Conclusion The IeDA intervention improved substantially HCWs’ adherence to IMCI’s clinical assessment tasks, leading to some overall increase in correct classifications but to no overall improvement in correct prescriptions. The largest improvements tended to be observed for less common conditions. For more common conditions, HCWs in the control districts performed relatively well, thus limiting the scope to detect an overall impact. Trial registration ClinicalTrials.gov NCT02341469; First submitted August 272,014, posted January 19, 2015.

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