Clinical trial NCT06380504: Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia
Official title: Effect of Leveraging Community-level Structures to Strengthen Prevention, Screening and Treatment of Severe Acute Malnutrition in Ethiopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Malnutrition, Severe
Malnutrition, Child
Wasting
Keywords: Outpatient Therapeutic Feeding Program
Treatment
Screening
Wasting
Severe acute malnutrition
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: Ethiopian Public Health Association
name: UNICEF
First posted: 2024-04-24
Enrollment: 1080
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial. Unit/cluster of assignment is health post catchment area. Parallel Assignment: baseline-endline design
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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.

Primary outcomes:
measure: Period prevalence of SAM OTP treatment coverage in children 6-59 months of age
timeFrame: After 24 months of program implementation
Secondary outcomes:
measure: Point prevalence of SAM OTP treatment coverage in children 6-59 months of age
timeFrame: After 24 months of program implementation
measure: Period prevalence of SAM OTP treatment coverage in the subgroup of treatment eligible children 6-59 months of age
timeFrame: After 24 months of program implementation
measure: Screening coverage of SAM
timeFrame: After 24 months of program implementation
measure: Screening coverage of severe underweight
timeFrame: After 24 months of program implementation
measure: Platform specific screening coverage of SAM
timeFrame: After 24 months of program implementation
measure: Growth Monitoring Promotion (GMP) consultation attendance
timeFrame: After 24 months of program implementation
measure: AFD group meeting attendance
timeFrame: After 24 months of program implementation
measure: AFD home visit coverage
timeFrame: After 24 months of program implementation
measure: Prevalence of SAM
timeFrame: After 24 months of program implementation
measure: Prevalence of wasting
timeFrame: After 24 months of program implementation
measure: Prevalence of stunting
timeFrame: After 24 months of program implementation
measure: Prevalence of underweight and severe underweight
timeFrame: After 24 months of program implementation
measure: Mean height-for-age Z-score (HAZ)
timeFrame: After 24 months of program implementation
measure: Mean weight-for-height Z-score (WHZ)
timeFrame: After 24 months of program implementation
measure: Mean weight-for-age Z-score (WAZ)
timeFrame: After 24 months of program implementation
measure: Mean mid-upper arm circumference (MUAC)
timeFrame: After 24 months of program implementation
measure: Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting
timeFrame: After 24 months of program implementation
measure: Vaccination coverage
timeFrame: After 24 months of program implementation
measure: Introduction of (semi) solid and soft complementary foods
timeFrame: After 24 months of program implementation
measure: Minimum dietary diversity in infants and young children (6-23 mo)
timeFrame: After 24 months of program implementation
measure: Nr of food groups consumed by infants and young children (6-59 mo)
timeFrame: After 24 months of program implementation
measure: Minimum meal frequency in infants and young children
timeFrame: After 24 months of program implementation
measure: Minimum acceptable diet in infants and young children
timeFrame: After 24 months of program implementation
measure: Continuous breastfeeding 12-23 months
timeFrame: After 24 months of program implementation
measure: Egg and/or flesh food consumption
timeFrame: After 24 months of program implementation
measure: Sweet beverage consumption
timeFrame: After 24 months of program implementation
measure: Zero vegetable or fruit consumption consumption
timeFrame: After 24 months of program implementation
measure: Minimum milk feeding frequency for non-breastfed children
timeFrame: After 24 months of program implementation
measure: Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP)
timeFrame: 24 months from baseline until endline of the study
measure: SAM OTP adherence
timeFrame: 24 months from baseline until endline of the study
measure: Weight gain rate during SAM OTP
timeFrame: 24 months from baseline until endline of the study
measure: SAM OTP outcomes (drop-out, death, transfer, non-response rates)
timeFrame: 24 months from baseline until endline of the study
measure: SAM OTP duration
timeFrame: 24 months from baseline until endline of the study
Other outcomes:
Locations:
city: Jimma
country: Ethiopia
facility: Kersa and Jeldessa woredas
Study officials:
affiliation: International Food Policy Research Institute
name: Lieven Huybregts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ethiopian Public Health Association
name: Tefera Belachew, PhD
role: PRINCIPAL_INVESTIGATOR
References: