Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia

NCT ID: NCT06380504

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1080 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2027-06-30

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

Conditions

Acute Malnutrition, Severe; Malnutrition, Child; Wasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard of Care

• Usual screening of wasting by health extension workers (HEW) using MUAC
• Previous introduction of Family-led MUAC (not maintained)
• Behavior Change Communication (BCC) offered by Health extension worker (low intensity)
• Treatment of SAM at health post or health center
• Follow-up of SAM OTP defaults through home visits by HEW (very low intensity)

Group Type: NO_INTERVENTION

No interventions assigned to this group

R-SWITCH integrated intervention package

1. Monthly group meetings of AFD community groups

2. Introduction of weight-for-age Z-score <-3 as an additional screening criterion

3. Promotion of Family-led MUAC screening and SAM awareness to fathers, community and religious leaders

4. Follow-up and counselling during home visits by AFD leaders

5. Strengthening communication between HEW and AFDs

Group Type: EXPERIMENTAL

R-SWITCH integrated intervention package

Intervention Type: BEHAVIORAL

1. Monthly group meetings of Alliance for Development (AFD) community groups) and their members (caregivers of children 0-59 months of age):

• Introduction and refresher of Family-led MUAC
• Active screening of wasting by AFD
• Group SBCC on Infant and Young Child Feeding (IYCF), health and Water, Sanitation and Hygiene (WaSH) with a focus on SAM
• Promotion of health services such as GMP

2. Introduction of weight-for-age Z-score <-3 as screening criterion for passive screening by health extension workers at any contact with children (e.g. during GMP)

3. Promotion of Family-led MUAC screening and SAM awareness to fathers during male agricultural/pastoralist extension activities and by community and religious leaders (creating social support)

4. Follow-up and counselling during home visits by AFD leaders of i) earlier referred cases of SAM, ii) cases enrolled in SAM OTP, iii) and recovered SAM cases discharged from OTP

5. Strengthening communication between HEW and AFDs

Interventions

R-SWITCH integrated intervention package

1. Monthly group meetings of Alliance for Development (AFD) community groups) and their members (caregivers of children 0-59 months of age):

• Introduction and refresher of Family-led MUAC
• Active screening of wasting by AFD
• Group SBCC on Infant and Young Child Feeding (IYCF), health and Water, Sanitation and Hygiene (WaSH) with a focus on SAM
• Promotion of health services such as GMP

2. Introduction of weight-for-age Z-score <-3 as screening criterion for passive screening by health extension workers at any contact with children (e.g. during GMP)

3. Promotion of Family-led MUAC screening and SAM awareness to fathers during male agricultural/pastoralist extension activities and by community and religious leaders (creating social support)

4. Follow-up and counselling during home visits by AFD leaders of i) earlier referred cases of SAM, ii) cases enrolled in SAM OTP, iii) and recovered SAM cases discharged from OTP

5. Strengthening communication between HEW and AFDs

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ethiopian Public Health Association

UNKNOWN

Sponsor Role: collaborator

UNICEF

OTHER

Sponsor Role: collaborator

International Food Policy Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lieven Huybregts, PhD

Role: PRINCIPAL_INVESTIGATOR

International Food Policy Research Institute

Tefera Belachew, PhD

Role: PRINCIPAL_INVESTIGATOR

Ethiopian Public Health Association

Locations

Kersa and Jeldessa woredas

Jimma, , Ethiopia

Site Status: RECRUITING

Countries

Ethiopia

Central Contacts

Lieven Huybregts, PhD

Role: CONTACT

l.huybregts@cgiar.org

202 862-6481 ext. +1

Alemayehu Haddis, PhD

Role: CONTACT

alemayehuh@etpha.org

Other Identifiers

RSWITCH-Ethiopia

Identifier Type: -

Identifier Source: org_study_id