Clinical trial NCT02397772: Impact of Alternative Treatment Strategies and Delivery Systems for Soil-transmitted Helminths in Kenya
Official title: The Impact of Different Treatment Strategies on the Transmission Dynamics of Soil-transmitted Helminths: a Cluster Randomised Trial in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helminthiasis
Nematode Infection
Disease Transmission, Infectious
Keywords: Soil-transmitted helminths
Intestinal Nematodes
Hookworm
Ascaris
Mass Treatment
Kenya
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: Kenya Ministry of Health
name: Imperial College London
name: Emory University
First posted: 2015-03-25
Enrollment: 21761
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of hookworm in community members
timeFrame: Endline survey conducted, approximately 24 months after starting the intervention
Secondary outcomes:
measure: Prevalence of Ascaris lumbricoides in community members
timeFrame: Endline survey conducted, approximately 24 months after starting the intervention
measure: Intensity of infection for each STH species
timeFrame: Endline survey conducted, approximately 24 months after starting the intervention
measure: Treatment coverage
timeFrame: Up to month following treatment
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: London School of Hygeiene & Tropical Medicine
name: Rachel L Pullan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halliday KE, Oswald WE, Mcharo C, Beaumont E, Gichuki PM, Kepha S, Witek-McManus SS, Matendechero SH, El-Busaidy H, Muendo R, Chiguzo AN, Cano J, Karanja MW, Musyoka LW, Safari TK, Mutisya LN, Muye IJ, Sidigu MA, Anderson RM, Allen E, Brooker SJ, Mwandawiro CS, Njenga SM, Pullan RL. Community-level epidemiology of soil-transmitted helminths in the context of school-based deworming: Baseline results of a cluster randomised trial on the coast of Kenya. PLoS Negl Trop Dis. 2019 Aug 9;13(8):e0007427. doi: 10.1371/journal.pntd.0007427. eCollection 2019 Aug.
citation: Pullan RL, Halliday KE, Oswald WE, Mcharo C, Beaumont E, Kepha S, Witek-McManus S, Gichuki PM, Allen E, Drake T, Pitt C, Matendechero SH, Gwayi-Chore MC, Anderson RM, Njenga SM, Brooker SJ, Mwandawiro CS. Effects, equity, and cost of school-based and community-wide treatment strategies for soil-transmitted helminths in Kenya: a cluster-randomised controlled trial. Lancet. 2019 May 18;393(10185):2039-2050. doi: 10.1016/S0140-6736(18)32591-1. Epub 2019 Apr 18.
citation: Brooker SJ, Mwandawiro CS, Halliday KE, Njenga SM, Mcharo C, Gichuki PM, Wasunna B, Kihara JH, Njomo D, Alusala D, Chiguzo A, Turner HC, Teti C, Gwayi-Chore C, Nikolay B, Truscott JE, Hollingsworth TD, Balabanova D, Griffiths UK, Freeman MC, Allen E, Pullan RL, Anderson RM. Interrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya. BMJ Open. 2015 Oct 19;5(10):e008950. doi: 10.1136/bmjopen-2015-008950.