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

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02397772

Collaborator

Kenya Medical Research Institute (Other), Kenya Ministry of Health (Other), Imperial College London (Other), Emory University (Other)

21,761

Enrollment

Location

Arms

Actual Duration (Months)

776.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Helminthiasis Nematode Infection Disease Transmission, Infectious	Drug: albendazole	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21761 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: albendazole Single dose of albendazole (400 mg) Other Names: Zentel
Experimental: 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.	Drug: albendazole Single dose of albendazole (400 mg) Other Names: Zentel
Experimental: 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	Drug: albendazole Single dose of albendazole (400 mg) Other Names: Zentel

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: albendazole

Single dose of albendazole (400 mg)

Other Names:

Zentel

Experimental: 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.

Drug: albendazole

Single dose of albendazole (400 mg)

Other Names:

Zentel

Experimental: 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

Drug: albendazole

Single dose of albendazole (400 mg)

Other Names:

Zentel

Outcome Measures

Primary Outcome Measures

Prevalence of hookworm in community members [Endline survey conducted, approximately 24 months after starting the intervention]
The prevalence of hookworm will be measured in a final age-stratified, community cross-sectional survey, which will be conducted approximately 24 months after the start of the intervention. Selected individuals will be asked to provide a stool sample which will be examined in duplicate and within one hour of preparation using the Kato-Katz method. Parasite prevalence will be defined as the proportion of slides that are positive for hookworm eggs. A baseline survey will be conducted prior to implementing the intervention and an interim survey conducted at 12 months. In a random subset of individuals, additional confirmatory diagnosis of infection will be based on real-time polymerase chain reaction (PCR).

Secondary Outcome Measures

Prevalence of Ascaris lumbricoides in community members [Endline survey conducted, approximately 24 months after starting the intervention]
The prevalence of Ascaris will be measured in a final age-stratified, community cross-sectional survey, which will be conducted approximately 24 months after the start of the intervention. Selected individuals will be asked to provide a stool sample which will be examined in duplicate and within one hour of preparation using the Kato-Katz method. Parasite prevalence will be defined as the proportion of slides that are positive for hookworm eggs. A baseline survey will be conducted prior to implementing the intervention and an interim survey conducted at 12 months. In a random subset of individuals, additional confirmatory diagnosis of infection will be based on real-time PCR.
Intensity of infection for each STH species [Endline survey conducted, approximately 24 months after starting the intervention]
The intensity of STH species will be measured in a final age-stratified, community cross-sectional survey, which will be conducted approximately 24 months after the start of the intervention. Selected individuals will be asked to provide a stool sample which will be examined in duplicate and within one hour of preparation using the Kato-Katz method. Intensity of infection will be quantified as eggs per gram of faeces. A baseline survey will be conducted prior to implementing the intervention and an interim survey conducted at 12 months.
Treatment coverage [Up to month following treatment]
• Treatment coverage will be measured using both routine data, and data collected during scheduled STH stool surveys. Teachers and community health workers (CHWs) will be provided with treatment registers and asked to provide a full record of all individuals who have received treatment. To augment these data, population-based coverage surveys using multistage clustering sampling will be carried out among a random subsample of communities.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.