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

Malnutrition, Child Clinical Trial

— R-SWITCH  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441305
• Other study ID #: RSWITCH-Kenya
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: International Food Policy Research Institute
• Contact: Elodie Becquey, PhD
• Phone: 778487085
• Email: e.becquey[@]cgiar.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1600
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child
• Severe Acute Malnutrition
• Wasting

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
International Food Policy Research Institute	Kenyatta University, UNICEF

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Period prevalence of severe wasting (SAM) treatment coverage in children 6-59 months of age	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	Point prevalence of SAM outpatient therapeutic program (OTP) treatment coverage in children 6-59 months of age	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
Secondary	Screening coverage of SAM	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
Secondary	Prevalence of SAM	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
Secondary	Prevalence of very low WHZ	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
Secondary	Prevalence of very low MUAC	Defined as the proportion of children aged 6-59 months with MUAC<115 mm	After 24 months of program implementation
Secondary	Prevalence of moderate acute malnutrition (MAM)	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
Secondary	Prevalence of wasting	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
Secondary	Prevalence of stunting	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
Secondary	Prevalence of underweight and severe underweight	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
Secondary	Mean height-for-age Z-score (HAZ)	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
Secondary	Mean weight-for-height Z-score (WHZ)	In 6-59 months old children.To calculate WHZ scores the 2006 WHO growth reference will be used	After 24 months of program implementation
Secondary	Mean weight-for-age Z-score (WAZ)	In 6-59 months old children.To calculate WAZ scores the 2006 WHO growth reference will be used	After 24 months of program implementation
Secondary	Mean mid-upper arm circumference (MUAC)	In 6-59 months old children.	After 24 months of program implementation
Secondary	Caregiver's knowledge score	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
Secondary	Prevalence of appropriate immunization	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
Secondary	Coverage of the integrated management of acute malnutrition (IMAM) platform	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
Secondary	Coverage of the community unit platform	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
Secondary	Coverage of family MUAC	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
Secondary	Coverage of family MUAC training	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
Secondary	Coverage of MUAC tapes	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
Secondary	Coverage of WAZ screening	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
Secondary	Mean longitudinal prevalence of child morbidity	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