Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02397772
Study type Interventional
Source London School of Hygiene and Tropical Medicine
Contact
Status Completed
Phase Phase 4
Start date March 2015
Completion date July 2017

See also
  Status Clinical Trial Phase
Completed NCT04041453 - Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients Phase 2
Active, not recruiting NCT03014167 - Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) Phase 3
Completed NCT02385058 - Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population Phase 4
Withdrawn NCT02636803 - Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults Phase 2
Completed NCT02725255 - Design and Clinical Evaluation of a School Meal With Deworming Properties Phase 2/Phase 3
Active, not recruiting NCT04227834 - Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education N/A
Completed NCT03173742 - Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil) Phase 1
Completed NCT00130910 - Treatment of Helminth co-Infection: Short-Term Effects on HIV-1 Progression Markers and Immune Activation N/A
Completed NCT00004996 - Comparison of Immune Response in Normal Volunteers and Patients With Helminth Infections
Recruiting NCT00001230 - Host Response to Infection and Treatment in Filarial Diseases
Completed NCT04041427 - Urine Albendazole Levels for Coverage Assessment N/A
Completed NCT02396407 - Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health N/A
Terminated NCT01271049 - An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths N/A
Terminated NCT00817713 - Can Presumptive Anthelminthic Treatment Delay the Progression of HIV in ART-naïve Patients in Rural Africa? N/A
Completed NCT02362932 - The Effect of an Urban Sanitation Intervention on Child Health N/A
Completed NCT02420574 - Assessment of Drug Efficacy of Local Albendazole N/A
Completed NCT00507221 - Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression N/A
Completed NCT00469495 - Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis N/A
Recruiting NCT01308268 - Management of Soil-transmitted Helminthiasis and Strongyloidiasis N/A
Recruiting NCT01459146 - Artemisinin-based Combination Therapy-Intermittent Preventive Treatment (ACT-IPT) Trial Among Schoolchildren in Kassena-Nankana, Ghana Phase 4