Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-06
Brief Title:
Expanding Coverage of Severe Acute Malnutrition SAM Treatment in Kenya
Sponsor:
International Food Policy Research Institute
Organization:
International Food Policy Research Institute
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R-SWITCH
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None