Clinical trial NCT06441305: Expanding Coverage of Severe Acute Malnutrition (SAM) Treatment in Kenya
Official title: Assessing the Impact, Implementation and Cost of Empowering Community Health Promoters to Improve Wasting Treatment Coverage in Turkana County Through Family-led MUAC Scale-up, Weight-for-age Screening, and Defaulters' Follow-up
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: UNICEF
name: Kenyatta University
First posted: 2024-06-04
Enrollment: 1600
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 community unit catchment area. Parallel Assignment: baseline-endline design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Child wasting is a type of malnutrition which occurs when a child becomes too thin. This medical condition increases the risk of becoming sick or dying. A child with severe wasting needs to be seen in a medical consultation to check on health status and to receive some medicine and a medical food supplement for daily consumption until cured. Yet, only a small proportion of children suffering from severe wasting are presently receiving appropriate treatment.

In Kenya, there is an opportunity to build on the existing network of community health promoters (CHPs) to increase the number of children with wasting who are identified and treated. In intervention areas, CHPs will be equipped with smartphones and an application which provides guidance on household members to visit and simple actions to take, related to health. CHPs will distribute color-coded mid-upper arm circumference tapes to households with young children and train caregivers on how to use it. After training, CHPs will send Short Message Services (SMS) to remind caregivers to regularly measure the arm circumference of the child. In addition, CHPs will receive a scale to measure the weight of children every month. Finally, wasted children registered in the treatment program who fail to attend a planned consultation will be flagged to their CHP through the phone application, and CHPs will conduct a specific home visit to investigate and help solve potential issues.

The study will assess whether this community intervention (called SWITCH) allows to identify and treat more children suffering from severe wasting. Before the start of the intervention, the proportion of wasted children receiving treatment in 40 community units in Turkana South, Turkana East and Aroo will be assessed. After this survey, a computer will randomly select 20 community units where the intervention will be scaled up. The survey will be repeated after 2 years to assess if the proportion of severely wasted children receiving treatment is higher in the area where the intervention was scaled up compared to the area where it was not scaled up.

In addition, after 1 year of implementation, the study will assess how the intervention was scaled up, what are the main challenges, and what are the overall perceptions on the intervention in the community among those who receive it and those who deliver it. Finally, costs of the various components of the intervention will be measured for all actors involved, including for caregivers.

Detailed description: Despite the burden and impact of child wasting on morbidity and mortality, only a small proportion of severely wasted children are presently receiving treatment. In Kenya, there is an opportunity to strengthen the screening for wasting and the identification and treatment of wasted children (SWITCH) through community health promoters (CHPs) who, per policy, are trained, equipped, incentivized and supervised by community health agents (CHAs).

An intervention package will be implemented including: 1) Digitization to support CHPs, 2) Family-led Mid-Upper Arm Circumference (MUAC) enhanced by digitization, with a two-way messaging platform between CHP and caregivers, and reminders for timely training at 6 months of age, 3) Equipment of CHPs with a baby-mother scale for measurement of weight-for-age to detect likely wasting, and 4) Real-time follow-up in the community (facilitated by digitization) of defaulters and non-respondent children enrolled for wasting treatment.

A randomized controlled trial will be used to assess the impact of the SWITCH intervention on severe wasting treatment coverage in Turkana. Twenty randomly selected community units of 40 will receive the intervention. An exhaustive screening campaign conducted at baseline and endline (after 2 years) in the 40 community units will identify children with severe wasting (MUAC \< 115 mm or Weight-for-Height Z-score \< -3 or bilateral pitting oedema) or recovering from severe wasting (defined by receipt and consumption of Ready-to-Use Therapeutic Food), who will be enrolled in a survey assessing treatment coverage, program exposure and other pathways to impact, and confounders.

In addition, the study will assess the reach, adoption by CHPs, and implementation challenges of the SWITCH package through additional qualitative (interviews and observations) and quantitative data collection at all levels of program delivery (beneficiaries, CHPs, CHAs, program implementers); and the unit cost of the SWITCH package per beneficiary (and cost-effectiveness if the package is effective) through an activity-based costing-ingredients approach.

Eligibility criteria: Inclusion Criteria:

* Household in a village of the study area covered by a CHP (although the child may or may not be registered by a CHP) AND
* Child is 6-59.9 months of age AND
* Caregiver consents to be part of the study AND
* any of the following:

  * WHZ \< -3 (relative to WHO 2006 reference) OR
  * MUAC \<115 mm OR
  * Presence of bilateral edema OR
  * receiving treatment as follow-up for an initial SAM condition on the way to full recovery

exclusion criteria is:

* Congenital malformation that makes anthropometric measurements impossible.
* Length is below 54 cm or height is above 120cm.

Primary outcomes:
measure: Period prevalence of severe wasting (SAM) treatment coverage in children 6-59 months of age
timeFrame: After 24 months of program implementation
Secondary outcomes:
measure: Point prevalence of SAM outpatient therapeutic program (OTP) treatment coverage in 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: Prevalence of SAM
timeFrame: After 24 months of program implementation
measure: Prevalence of very low WHZ
timeFrame: After 24 months of program implementation
measure: Prevalence of very low MUAC
timeFrame: After 24 months of program implementation
measure: Prevalence of moderate acute malnutrition (MAM)
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 score
timeFrame: After 24 months of program implementation
measure: Prevalence of appropriate immunization
timeFrame: After 24 months of program implementation
measure: Coverage of the integrated management of acute malnutrition (IMAM) platform
timeFrame: After 24 months of program implementation
measure: Coverage of the community unit platform
timeFrame: After 24 months of program implementation
measure: Coverage of family MUAC
timeFrame: After 24 months of program implementation
measure: Coverage of family MUAC training
timeFrame: After 24 months of program implementation
measure: Coverage of MUAC tapes
timeFrame: After 24 months of program implementation
measure: Coverage of WAZ screening
timeFrame: After 24 months of program implementation
measure: Mean longitudinal prevalence of child morbidity
timeFrame: After 24 months of program implementation
Other outcomes:
Locations:
city: Lodwar
country: Kenya
facility: Turkana South and Turkana East and Aroo
Study officials:
affiliation: International Food Policy Research Institute
name: Elodie Becquey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenyatta University
name: Sophie Ochola, PhD
role: PRINCIPAL_INVESTIGATOR
References: