Effect of Leveraging Community-level Structures to Strengthen Prevention, Screening and Treatment of Severe Acute Malnutrition in Ethiopia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,080
- Locations
- 1
- Primary Endpoint
- Period prevalence of SAM OTP treatment coverage in children 6-59 months of age
Study Overview
Brief Summary
The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness.
Detailed Description
Despite the high mortality risk of severe wasting (also referred to as severe acute malnutrition or SAM), only a small proportion of children with severe wasting are currently identified and admitted to available outpatient treatment programs (OTP). In 2020, an estimated 4.9 million children with severe wasting received treatment, approximately a third of the total burden. Outside of humanitarian settings, this proportion is even lower (estimated to be around 15%). These figures highlight the urgent need to increase treatment coverage to meet the Sustainable Development Goals (SDG), which aim to reduce the prevalence of child wasting to less than 5% by 2025 and less than 3% by 2030. The continuum of care for SAM, from case identification, referral to treatment, and post-treatment follow-up, is hampered by several barriers including caregiver lack of awareness on the risks and treatment services of SAM, stigma related to SAM, poor accessibility to treatment, frequent stockouts of treatment inputs, and the overall workload faced by first-line health workers.
The R-SWITCH intervention will leverage existing community groups to deliver an integrated package aimed at preventing SAM through behavior change communication (BCC) on child nutrition and health, increasing wasting screening coverage through active screening, family-led MUAC and improved passive screening health posts, increasing treatment coverage through follow-up of earlier referred cases, cases enrolled in OTP, and children who completed OTP and recovered.
The primary objectives of the R-SWITCH studies are:
- To assess the impact of the R-SWITCH intervention on SAM OTP coverage
- To identify implementation barriers and facilitators
- To assess the cost-efficiency and cost-effectiveness of the intervention package and services
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
Evaluator teams will be blinded from intervention allocation
Eligibility Criteria
- Ages
- 6 Months to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Child 6-59 months of age
- •Suffering from SAM (defined as MUAC < 115mm or presence of bilateral pitting edema or Weight-for-Length Z-score <-3) OR currently enrolled in SAM OTP
Exclusion Criteria
- •Anthropometric malformation or being handicapped which hampers anthropometric measurements.
Outcomes
Primary Outcomes
Period prevalence of SAM OTP treatment coverage in children 6-59 months of age
Time Frame: After 24 months of program implementation
Defined as the proportion of children with Severe Acute Malnutrition (SAM) or enrolled in the SAM Outpatient Therapeutic program (OTP) that are "under treatment". * SAM is defined as a Mid-Upper Arm Circumference \<115mm or a weight-for-height Z-score \<-3 (relative to the World Health Organization (WHO) 2006 growth standards) or presence of bilateral pitting edema. * "Under treatment" is defined as: * the caregiver acknowledging the child is enrolled in a SAM OTP AND * the child was fed ready-to-use therapeutic food (RUTF) over the last three days AND * the caregiver can either show at least one full RUTF sachet OR more than one empty RUTF sachet.
Secondary Outcomes
- AFD group meeting attendance(After 24 months of program implementation)
- Growth Monitoring Promotion (GMP) consultation attendance(After 24 months of program implementation)
- Egg and/or flesh food consumption(After 24 months of program implementation)
- Sweet beverage consumption(After 24 months of program implementation)
- Platform specific screening coverage of SAM(After 24 months of program implementation)
- Mean weight-for-height Z-score (WHZ)(After 24 months of program implementation)
- Minimum dietary diversity in infants and young children (6-23 mo)(After 24 months of program implementation)
- Minimum milk feeding frequency for non-breastfed children(After 24 months of program implementation)
- Point prevalence of SAM OTP treatment coverage in children 6-59 months of age(After 24 months of program implementation)
- Screening coverage of severe underweight(After 24 months of program implementation)
- Prevalence of underweight and severe underweight(After 24 months of program implementation)
- Mean mid-upper arm circumference (MUAC)(After 24 months of program implementation)
- Minimum meal frequency in infants and young children(After 24 months of program implementation)
- Period prevalence of SAM OTP treatment coverage in the subgroup of treatment eligible children 6-59 months of age(After 24 months of program implementation)
- Screening coverage of SAM(After 24 months of program implementation)
- Prevalence of SAM(After 24 months of program implementation)
- Mean height-for-age Z-score (HAZ)(After 24 months of program implementation)
- Mean weight-for-age Z-score (WAZ)(After 24 months of program implementation)
- Introduction of (semi) solid and soft complementary foods(After 24 months of program implementation)
- Continuous breastfeeding 12-23 months(After 24 months of program implementation)
- AFD home visit coverage(After 24 months of program implementation)
- Prevalence of wasting(After 24 months of program implementation)
- Prevalence of stunting(After 24 months of program implementation)
- Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting(After 24 months of program implementation)
- Vaccination coverage(After 24 months of program implementation)
- Nr of food groups consumed by infants and young children (6-59 mo)(After 24 months of program implementation)
- Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP)(24 months from baseline until endline of the study)
- SAM OTP adherence(24 months from baseline until endline of the study)
- Minimum acceptable diet in infants and young children(After 24 months of program implementation)
- Zero vegetable or fruit consumption consumption(After 24 months of program implementation)
- Weight gain rate during SAM OTP(24 months from baseline until endline of the study)
- SAM OTP outcomes (drop-out, death, transfer, non-response rates)(24 months from baseline until endline of the study)
- SAM OTP duration(24 months from baseline until endline of the study)