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

Helminthiasis Clinical Trial

— TUMIKIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397772
• Other study ID #: 1354
• Secondary ID: 2826
• Status: Completed
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2018
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21761
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease Transmission, Infectious
• Helminthiasis
• Nematode Infection

Intervention

Drug:
• albendazole
Single dose of albendazole (400 mg)

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Nairobi

Sponsors (5)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Emory University, Imperial College London, Kenya Medical Research Institute, Kenya Ministry of Health

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of hookworm in community members	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).	Endline survey conducted, approximately 24 months after starting the intervention
Secondary	Prevalence of Ascaris lumbricoides in community members	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.	Endline survey conducted, approximately 24 months after starting the intervention
Secondary	Intensity of infection for each STH species	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.	Endline survey conducted, approximately 24 months after starting the intervention
Secondary	Treatment coverage	• 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.	Up to month following treatment