Overview

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

Status:
Completed
Trial end date:
2017-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborators:
Emory University
Imperial College London
Kenya Medical Research Institute
Kenya Ministry of Health
Treatments:
Albendazole
Criteria
Inclusion Criteria:

- Usual resident of study community or student enrolled in study school;

- Willingness of adult aged 18 years and above or parent/guardian to provide written
informed consent;

- Provision of written assent to participate from children aged 8 years and above.

Exclusion Criteria:

- Visitor to household at time of household visits;

- Refusal of informed consent;

- Refusal to assent by children aged 8 years and above.