A simplified, combined protocol versus standard treatment for acute malnutrition in children 6-59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan.

BACKGROUND: Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally. METHODS AND FINDINGS: A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) < 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to <12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI -0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI -0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints. CONCLUSIONS: Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230). TRIAL REGISTRATION: The trial is registered at ISRCTN, trial number ISRCTN30393230.

Factors influencing place of delivery for pastoralist women in Kenya: a qualitative study.

BACKGROUND: Kenya's high maternal mortality ratio can be partly explained by the low proportion of women delivering in health facilities attended by skilled birth attendants (SBAs). Many women continue to give birth at home attended by family members or traditional birth attendants (TBAs). This is particularly true for pastoralist women in Laikipia and Samburu counties, Kenya. This paper investigates the socio-demographic factors and cultural beliefs and practices that influence place of delivery for these pastoralist women. METHODS: Qualitative data were collected in five group ranches in Laikipia County and three group ranches in Samburu County. Fifteen in-depth interviews were conducted: seven with SBAs and eight with key informants. Nineteen focus group discussions (FGDs) were conducted: four with TBAs; three with community health workers (CHWs); ten with women who had delivered in the past two years; and two with husbands of women who had delivered in the past two years. Topics discussed included reasons for homebirths, access and referrals to health facilities, and strengths and challenges of TBAs and SBAs. The data were translated, transcribed and inductively and deductively thematically analysed both manually and using NVivo. RESULTS: Socio-demographic characteristics and cultural practices and beliefs influence pastoralist women's place of delivery in Laikipia and Samburu counties, Kenya. Pastoralist women continue to deliver at home due to a range of factors including: distance, poor roads, and the difficulty of obtaining and paying for transport; the perception that the treatment and care offered at health facilities is disrespectful and unfriendly; lack of education and awareness regarding the risks of delivering at home; and local cultural values related to women and birthing. CONCLUSIONS: Understanding factors influencing the location of delivery helps to explain why many pastoralist women continue to deliver at home despite health services becoming more accessible. This information can be used to inform policy and program development aimed at increasing the proportion of facility-based deliveries in challenging settings.

Community and provider perceptions of traditional and skilled birth attendants providing maternal health care for pastoralist communities in Kenya: a qualitative study.

BACKGROUND: Kenya has a high burden of maternal and newborn mortality. Consequently, the Government of Kenya introduced health system reforms to promote the availability of skilled birth attendants (SBAs) and proscribed deliveries by traditional birth attendants (TBAs). Despite these changes, only 10% of women from pastoralist communities are delivered by an SBA in a health facility, and the majority are delivered by TBAs at home. The aim of this study is to better understand the practices and perceptions of TBAs and SBAs serving the remotely located, semi-nomadic, pastoralist communities of Laikipia and Samburu counties in Kenya, to inform the development of an SBA/TBA collaborative care model. METHODS: This descriptive qualitative study was undertaken in 2013-14. We conducted four focus group discussions (FGDs) with TBAs, three with community health workers, ten with community women, and three with community men. In-depth interviews were conducted with seven SBAs and eight key informants. Topic areas covered were: practices and perceptions of SBAs and TBAs; rewards and challenges; managing obstetric complications; and options for SBA/TBA collaboration. All data were translated, transcribed and thematically analysed. RESULTS: TBAs are valued and accessible members of their communities who adhere to traditional practices and provide practical and emotional support to women during pregnancy, delivery and post-partum. Some TBA practices are potentially harmful to women e.g., restricting food intake during pregnancy, and participants recognised that TBAs are unable to manage obstetric complications. SBAs are acknowledged as having valuable technical skills and resources that contribute to safe and clean deliveries, especially in the event of complications, but there is also a perception that SBAs mistreat women. Both TBAs and SBAs identified a range of challenges related to their work, and instances of mutual respect and informal collaborations between SBAs and TBAs were described. CONCLUSIONS: These findings clearly indicate that an SBA/TBA collaborative model of care consistent with Kenyan Government policy is a viable proposition. The transition from traditional birth to skilled birth attendance among the pastoralist communities of Laikipia and Samburu is going to be a gradual one, and an interim collaborative model is likely to increase the proportion of SBA assisted deliveries, improve obstetric outcomes, and facilitate the transition.

Knowledge, attitudes and practices of traditional birth attendants in pastoralist communities of Laikipia and Samburu counties, Kenya: a cross-sectional survey.

INTRODUCTION: Current efforts to reduce maternal and newborn mortality focus on promoting institutional deliveries with skilled birth attendants (SBAs), and discouraging deliveries at home attended by traditional birth attendants (TBAs). In rural Kenya, semi-nomadic pastoralist communities are underserved by the formal health system, experience high maternal and neonatal mortality, and rely primarily on TBAs for delivery care, despite Government proscription of TBA-assisted births. This study examined the knowledge, attitude and practices of TBAs serving these communities to assess the potential for collaboration between TBAs and SBAs. METHODS: A cross-sectional, interviewer-administered survey was conducted among 171 TBAs from Maasai and Samburu pastoralist communities in Laikipia and Samburu counties, Kenya, as part of a larger mixed-methods study in partnership with a local service provider. RESULTS: BAs were relatively elderly (mean age 59.6 years), and attended an average of 5-6 deliveries per year. A minority (22.2%) had received formal training. They provided antenatal, intra-partum and post-partum care. Most TBA care was non-interventionist, but not necessarily consistent with best practice. Most had encountered birth complications, but knowledge regarding management of complications was sub-optimal. Most had previously referred at least one woman to a health facility (80.1%), were key participants in decision making to refer women (96.5%), and had been present at an institutional delivery (54.4%). CONCLUSION: TBAs continue to be key providers of maternal and neonatal healthcare in regions where the formal health system has poor coverage or acceptability. Strengthening existing TBA/SBA collaborations could improve both community links to the formal health system, and the quality of care provided to pastoralist women, while remaining consistent with current Government policy.