Expanding Coverage of Severe Acute Malnutrition (SAM) Treatment in Kenya (R-SWITCH)

International Food Policy Research Institute

Status: Enrolling

Conditions: Malnutrition, Child; Wasting; Acute Malnutrition, Severe

Treatments: Behavioral: SWITCH intervention package

Study type: Interventional

Funder types: Other

Identifiers

NCT06441305

RSWITCH-Kenya

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,600 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

* Register-based household registration (census) by CHP every 12 months * Some family MUAC of variable and unknown coverage/frequency, national guidance developed. * Some passive screening using weight-for-height z-score at Health Facility and during outreach during Malezi bora (child health week every 6 months). * Monthly compilation by CHA (supervisors) of the list of defaulters and non-respondents for transmission to relevant community health promoter (CHP) during monthly in-person meeting.

SWITCH intervention package

Experimental group

Description:

* Addition of digital monitoring \& supervision by CHA * Digitized registration of households by CHPs every 6 months * Digital reminders to CHP to conduct home visit if a child has never been visited in 3 mo. * Digital reminder for timely training to family MUAC of all family members through home visit by CHP when child turns 6 months of age. * Platform for 2-ways messaging: biweekly SMS reminders to caregivers through the CHP's app; feedback by caregiver * Community level screening based on weight and weight-for-age (WAZ) led by CHP every other month (aligned with Community Action Days), * Digital calculation of WAZ. * CHP and Growth Monitoring and Promotion refer to health facility if WAZ\<-3 to check on WHZ eligibility * At the end of every wasting treatment consultation, compilation of the list of defaulters and non-respondents, for immediate transmission by CHA to relevant CHP through digital task of an instruction for immediate follow-up.

Treatment:

Behavioral: SWITCH intervention package