Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2023
INTERVENTION: This is a non‐blinded, prospective, longitudinal, cluster‐randomized, controlled trial, using villages served by a single Family Health Worker (FHW; Community Health Worker) as the unit of randomisation. The Trial Treatment Package (iCCM+) will be the provision of treatment for uncomplicated acute malnutrition, in children 6 months to 5 years, by FHW at the village level. The treatment will consist of the provision of ready‐to‐use therapeutic food (RUTF) and presumptive treatment with amoxicillin and albendazole. The iCCM+ treatment package will be compared to the Current Treatment Package (iCCM) in which acute malnutrition is diagnosed by FHW but all cases are referred to a health facility for treatment. Diagnosis and treatment of pneumonia, malaria, and diarrhoea, and detection of danger signs followed by referral to a health facility, will be done in both study arms according to the current national (Somaliland) iCCM protocols. Study participants will be allocated to one of the study arms according to the village (cluster) that they live in. Thirty clusters will be randomly allocated to the two study arms to give 15 clusters in each arm. In each arm, a cohort of children will be enrolled and followed longitudinally, with data collection conducted at baseline and after 12 months to determine the coverage of acute malnutrition treatment. Children that develop acute malnutrition and are identified by the FHW during the trial will be identified and followed until their status is: completed treatment and discharged (recovered); died; defaulted; non‐progressed; non‐recovered; or transferred to a treatment site outside the trial area. Each study cluster will be comprised of a village (Somal CONDITION: Acute childhood malnutrition (wasting and/or nutritional oedema) ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: ; 1. Treatment coverage for moderate acute malnutrition (diagnosed using mid‐upper arm circumference (MUAC)), defined as being currently enrolled in a village‐level or facility treatment programme, measured using study records on the day of the data collection; 2. Treatment coverage for severe acute malnutrition (diagnosed using MUAC and/or nutritional oedema), defined as being currently enrolled in a village‐level or facility treatment programme, measured using study records on the day of the data collection; INCLUSION CRITERIA: 1. Children aged 6‐59 months 2. Living in households within the participating clusters (villages) SECONDARY OUTCOME: ; 1. Number of cases of acute malnutrition diagnosed by FHW measured using health worker record books over the study period; 2. Recovery (Number of cases successfully discharged by the FHW or health facility as recovered, divided by total discharges multiplied by 100) measured using household follow‐up interviews throughout the trial; 3. Non‐recovery proportion number of non‐responses and non‐progressions, divided by total discharges multiplied by 100) measured using household follow‐up interviews throughout the trial; 4. Default proportion (Number of defaulters divided by total discharges multiplied by 100) measured using household follow‐up interviews throughout the trial; 5. Relapse rate (proportion of cured children who become malnourished within 6 months of discharge) measured using household follow‐up interviews throughout the trial; 6. Death rate (Number of beneficiaries who died whilst registered in the programme, divided by total discharges multiplied by 100) measured using household follow‐up interviews throughout the trial; 7. Average length of stay in a treatment programme (days) measured using household follow‐up interviews throughout the trial. Length of stay is the number of days elapsed between admission and discharge. Average Length of Stay = Sum of Individual Length of stay (recovered beneficiaries) in days / Number of recovered beneficiaries.; 8. Average gain in MUAC (mm/week) measured using household follow‐up interviews throughout the trial; 9. Cost per child treated (admitted) measured using study and programme implementation cost records at the end of the study; 10. Cost per child cured/recovered measured using study and programme implementation cost records at the end of the study; 11. Prevalence of GAM at baseline and endline measured during baseline and endline surveys; 12. Number of diagnoses and diagnostic rate (diagnoses per 1,000 children/month) for each condition (ARI, malaria, diarrhoea, and acute malnutrition) measured using health worker record books over the study period;
Epistemonikos ID: 0fac02654115814a292e406172234233df977032
First added on: Aug 26, 2024