NCT02397772

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

The Impact of Different Treatment Strategies on the Transmission Dynamics of Soil-transmitted Helminths: a Cluster Randomised Trial in Kenya

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21,761 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will be conducted in two settings of Kenya that have contrasting epidemiological and programmatic characteristics, Kwale County on the south Kenyan coast and Bungoma County in western Kenya. Allocation to study group will be by cluster, using predefined units used in public health provision - termed Community Units (CUs), which comprise approximately 1,000 households or 5,000 people. CUs will be randomized to one of three groups, receiving either (i) annual school-based deworming; (ii) annual community-based deworming; (iii) biannual community-based deworming. In nine CUs, a longitudinal study will be conducted in order to better understand the transmission dynamics of STH.

Conditions

• Helminthiasis
• Nematode Infection
• Disease Transmission, Infectious

Interventions

Type	Name	Description
DRUG	albendazole	Single dose of albendazole (400 mg)

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2015-03-25
• Last updated: 2018-08-31

Locations

1 site across 1 country: Kenya