- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06441305
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elodie Becquey, PhD
- Phone Number: +221 778487085
- Email: e.becquey@cgiar.org
Study Contact Backup
- Name: Sophie Ochola, PhD
- Phone Number: +254 0721449803
- Email: ocholasa55@gmail.com
Study Locations
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Lodwar, Kenya
- Recruiting
- Turkana South and Turkana East and Aroo
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Contact:
- Elodie Becquey
- Phone Number: 00221778487085
- Email: e.becquey@cgiar.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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 |
|---|---|
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No Intervention: Standard of Care
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Experimental: SWITCH intervention package
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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:
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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
|
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Mean mid-upper arm circumference (MUAC)
Time Frame: After 24 months of program implementation
|
In 6-59 months old children.
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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
|
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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
Investigators
- Principal Investigator: Elodie Becquey, PhD, International Food Policy Research Institute
- Principal Investigator: Sophie Ochola, PhD, Kenyatta University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSWITCH-Kenya
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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