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