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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21761 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children

NCT01087099

Infections With Soil-Transmitted Helminths (STH)

COMPLETED PHASE4

Assessment of Drug Efficacy of Local Albendazole

NCT02420574

Helminthiasis

COMPLETED NA

Monitoring the Efficacy of Anthelmintics for the Treatment of Soil Transmitted Helminths P2

NCT01379326

Ascaris Lumbricoides Ascaris Suum Trichuris Trichiura +5 more

COMPLETED PHASE4

Evaluation of Effectiveness of ALBENDAZOLIVERMECTIN Coformulation vs ALBENDAZOLE for Treatment of Intestinal Worms

NCT05124691

Helminthes; Infestation, Intestinal

TERMINATED PHASE2/PHASE3

Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora

NCT01192802

Intestinal Diseases Helminthiasis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Helminthiasis Nematode Infection Disease Transmission, Infectious

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Annual school-based deworming

Pre-school and school children (typically 2-14 years) will receive albendazole treatment from trained school teachers, as part of the ongoing national school-based deworming programme.

Group Type ACTIVE_COMPARATOR

albendazole

Intervention Type DRUG

Single dose of albendazole (400 mg)

Annual community-based deworming

Standard school-based deworming supplemented by annual community-based deworming (2-99 years). All household members who are not enrolled in school will receive albendazole treatment from trained community health workers.

Group Type EXPERIMENTAL

albendazole

Intervention Type DRUG

Single dose of albendazole (400 mg)

Biannual

Biannual school- and community-based deworming (2-99 years). All household members who are not enrolled in school will receive albendazole treatment from trained community health workers

Group Type EXPERIMENTAL

albendazole

Intervention Type DRUG

Single dose of albendazole (400 mg)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

albendazole

Single dose of albendazole (400 mg)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zentel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.