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

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 4

Conditions: Disease Transmission, Infectious; Helminthiasis; Nematode Infection

Treatments: Drug: albendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02397772

2826 (Other Identifier)

1354

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21,761 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21,761 participants in 3 patient groups

Annual school-based deworming

Active Comparator group

Description:

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.

Treatment:

Drug: albendazole

Annual community-based deworming

Experimental group

Description:

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.

Treatment:

Drug: albendazole

Biannual

Experimental group

Description:

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

Treatment:

Drug: albendazole