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

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Lodwar, Kenya
        • Recruiting
        • Turkana South and Turkana East and Aroo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
  • 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.
Experimental: SWITCH intervention package
  • 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.
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Period prevalence of severe wasting (SAM) treatment coverage in children 6-59 months of age
Time Frame: After 24 months of program implementation

defined as the proportion of children suffering from SAM or recovering from SAM who currently receive treatment.

• SAM defined by weight-for-height Z-score (WHZ) <-3 (relative to World Health Organization (WHO) 2006 reference) or MUAC <115 mm or by the presence of bilateral edema.

Children recovering from SAM through treatment will be considered to receive treatment for an initial SAM condition if they both attended an IMAM consultation in the previous 15 days (as reported by caregiver OR by a consultation card) AND either:

  • consumed RUTF at least once in the previous 3 days (as reported by the caregiver AND confirmed by observation of >= 1 full or 2 empty RUTF sachets) OR
  • consumed RUSF at least once in the previous 3 days (as reported by the caregiver AND confirmed by observation by the enumerator of >= 1 full or 2 empty RUSF sachets) AND child was previously enrolled for SAM treatment immediately prior to MAM treatment (as confirmed by treatment card OR reported by the mother
After 24 months of program implementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean weight-for-height Z-score (WHZ)
Time Frame: After 24 months of program implementation
In 6-59 months old children.To calculate WHZ scores the 2006 WHO growth reference will be used
After 24 months of program implementation
Mean weight-for-age Z-score (WAZ)
Time Frame: After 24 months of program implementation
In 6-59 months old children.To calculate WAZ scores the 2006 WHO growth reference will be used
After 24 months of program implementation
Mean mid-upper arm circumference (MUAC)
Time Frame: After 24 months of program implementation
In 6-59 months old children.
After 24 months of program implementation
Point prevalence of SAM outpatient therapeutic program (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 SAM at the time of the survey that are under treatment (see definition under primary outcome)
After 24 months of program implementation
Screening coverage of SAM
Time Frame: After 24 months of program implementation
Defined as the proportion of children aged 6-59 months suffering from SAM ((currently or on their way to recovery from SAM through treatment for an initial SAM condition) ) screened for wasting over the last 30 days (as reported by the caregiver)
After 24 months of program implementation
Prevalence of SAM
Time Frame: After 24 months of program implementation
Defined as the proportion of children aged 6-59 months with SAM (defined as WHZ <-3 (relative to World Health Organization (WHO) 2006 reference) or a MUAC < 115 mm or the presence of bilateral pitting edema).
After 24 months of program implementation
Prevalence of very low WHZ
Time Frame: After 24 months of program implementation
Defined as the proportion of children aged 6-59 months with WHZ <-3 (relative to World Health Organization (WHO) 2006 reference).
After 24 months of program implementation
Prevalence of very low MUAC
Time Frame: After 24 months of program implementation
Defined as the proportion of children aged 6-59 months with MUAC<115 mm
After 24 months of program implementation
Prevalence of moderate acute malnutrition (MAM)
Time Frame: After 24 months of program implementation
Defined as the proportion of children aged 6-59 months with MAM (defined as -3<= WHZ <-2 (relative to World Health Organization (WHO) 2006 reference) or 115<= MUAC < 125 mm).
After 24 months of program implementation
Prevalence of wasting
Time Frame: After 24 months of program implementation
Defined as the proportion of children aged 6-59 months with wasting (defined as WHZ <-2 (relative to World Health Organization (WHO) 2006 reference) or a MUAC < 125 mm or the presence of bilateral pitting edema).
After 24 months of program implementation
Prevalence of stunting
Time Frame: After 24 months of program implementation
Defined as the proportion of children aged 6-59 months suffering from SAM or recovering from SAM with stunting (defined as height-for-age Z-scores (HAZ) <-2 or a MUAC < 125 mm or the presence of bilateral pitting edema). To calculate HAZ scores the 2006 WHO growth reference will be used
After 24 months of program implementation
Prevalence of underweight and severe underweight
Time Frame: After 24 months of program implementation
Defined as the proportion of children aged 6-59 months suffering from SAM or recovering from SAM with underweight (defined as weight-for-age Z-scores (WAZ) <-2 ) and severe underweight (defined as WAZ <-3 ). To calculate WAZ scores the 2006 WHO growth reference will be used
After 24 months of program implementation
Mean height-for-age Z-score (HAZ)
Time Frame: After 24 months of program implementation
In 6-59 months old children suffering from SAM or recovering from SAM. Scores will be calculated relative to World Health Organization (WHO) 2006 reference, with a higher score meaning a better outcome
After 24 months of program implementation
Caregiver's knowledge score
Time Frame: After 24 months of program implementation
The score will be calculated by adding one point for each right answer to a series of questions related to infant and child feeding, child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting. Questions were specifically developed for the study based on program activities and asked to caregiver of children aged 6-59 months suffering from SAM or recovering from SAM
After 24 months of program implementation
Prevalence of appropriate immunization
Time Frame: After 24 months of program implementation
Proportion of children aged 6-18 months with SAM or enrolled in SAM OTP who received all recommended immunizations
After 24 months of program implementation
Coverage of the integrated management of acute malnutrition (IMAM) platform
Time Frame: After 24 months of program implementation
proportion of children aged 6-59 months suffering from SAM or recovering from SAM who attended an IMAM consultation in the previous 15 days (as reported by the caregiver or by an IMAM treatment card)
After 24 months of program implementation
Coverage of the community unit platform
Time Frame: After 24 months of program implementation
proportion of children aged 6-59 months suffering from SAM or recovering from SAM in contact with a CHP in the 2 months preceding the survey for community care-related matter (as reported by the caregiver)
After 24 months of program implementation
Coverage of family MUAC
Time Frame: After 24 months of program implementation
proportion of children aged 6-59 months suffering from SAM or recovering from SAM screened in the month preceding the survey by a family member using a MUAC tape (as reported by the caregiver)
After 24 months of program implementation
Coverage of family MUAC training
Time Frame: After 24 months of program implementation
proportion of children aged 6-59 months suffering from SAM or recovering from SAM for which at least one family member was trained to use MUAC tape (as reported by the caregiver)
After 24 months of program implementation
Coverage of MUAC tapes
Time Frame: After 24 months of program implementation
proportion of children aged 6-59 months suffering from SAM or recovering from SAM for which at least one family member owns a MUAC tape (as reported by the caregiver AND confirmed by observation)
After 24 months of program implementation
Coverage of WAZ screening
Time Frame: After 24 months of program implementation
proportion of children aged 6-59 months suffering from SAM or recovering from SAM weighed in the 2 months preceding the survey by a CHP or a health staff using a scale (as reported by the caregiver)
After 24 months of program implementation
Mean longitudinal prevalence of child morbidity
Time Frame: After 24 months of program implementation
In children aged 6-59 months suffering from SAM or recovering from SAM, defined as the number of days of illness (acute respiratory infections, fever, diarrhea, vomiting) in the past 3 days (as reported by the caregiver) divided by the total number of days of report (usually 3). A diarrheal episode is defined as at least three loose stools in the last 24 hours, or stools with blood. Fever will be measured by a thermometer by enumerators and the history of fever in the previous days will also be recalled from the mother. The presence of an acute respiratory infection (ARI) will be assessed by recalling the specific symptoms associated with ARI (cough, difficulty breathing, rapid breathing, runny nose).
After 24 months of program implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Elodie Becquey, PhD, International Food Policy Research Institute
  • Principal Investigator: Sophie Ochola, PhD, Kenyatta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be carefully anonymized and de-identified so that the privacy of participants and research subjects is fully protected. Databases will be anonymized using identification codes. No names, GPS coordinates, dates of birth or other identifying data will be stored in the databases.

At the time of publication of scientific articles presenting primary results, the fully anonymized databases (quantitative data) will become a public good and will be made available to the scientific community, government, and partners.

IPD Sharing Time Frame

At the time of publication of scientific articles presenting primary results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wasting

Clinical Trials on SWITCH intervention package

Subscribe