drugset / Trial / NCT02397772

Impact of Alternative Treatment Strategies and Delivery Systems for Soil-transmitted Helminths in Kenya

NCT02397772 ↗

RandomizedSingle-groupOpen-labelTreatment

Summary

The mainstay of control of soil-transmitted helminths (STH) is school-based deworming but recent modelling has highlights that in all but low very transmission settings, the treatment of school-aged children is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH and if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? In this study, two paired community cluster randomised trials in different settings in Kenya will evaluate the impact and cost-effectiveness of annual school-based deworming, annual community-based deworming, and biannual community-based deworming. The interventions are (i) annual mass anthelmintic treatment delivered either to pre-school and school-aged children, as part of a national school-based deworming programme, or to the entire community delivered by community health workers. The primary outcome measure is the prevalence of hookworm infection (the most common STH species), assessed by periodic cross-sectional, age-stratified parasitological surveys. Secondary outcomes include intensity of hookworm, prevalence and intensity of Ascaris lumbricoides, treatment coverage, and among a randomly selected sub-sample of participants who will be followed longitudinally, worm burden and proportion of eggs unfertilised. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis will investigate the community acceptability, feasibility given the local and regional health system structures and processes, and scale-up of the interventions.

Timeline

Start
2015-03
Primary completion
2017-06
Completion
2017-07

Outcome

Met primary endpoint

paper Relative to annual school-based treatment, the risk ratio for annual community-wide treatment was 0·59 (95% CI 0·42-0·83; p<0·001) PMID 31006575 ↗

paper Community-wide treatment was more effective in reducing hookworm prevalence and intensity than school-based treatment PMID 31006575 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Albendazole Small molecule 400 mg —