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

NCT02397772 | Completed Phase 4 DMC

• 2 other identifiers: 13542826
• Study Type: interventional
• Target: 21,761
• Locations: 1 country
• Sites: 1

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.

Conditions

Helminthiasis; Nematode Infection; Disease Transmission, Infectious

Keywords

Soil-transmitted helminths; Intestinal Nematodes; Hookworm; Ascaris; Mass Treatment; Kenya

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prevalence of Ascaris lumbricoides in community members

  Endline survey conducted, approximately 24 months after starting the intervention

• Intensity of infection for each STH species

  Endline survey conducted, approximately 24 months after starting the intervention

• Treatment coverage

  Up to month following treatment

Study Arms (3)

Annual school-based deworming

ACTIVE COMPARATOR

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

Annual community-based deworming

EXPERIMENTAL

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

Biannual

EXPERIMENTAL

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

Interventions

albendazole DRUG

Single dose of albendazole (400 mg)

Also known as: Zentel

Annual community-based deworming; Annual school-based deworming; Biannual

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Visitor to household at time of household visits;
• Refusal of informed consent;
• Refusal to assent by children aged 8 years and above.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Kenya Medical Research Institute: collaborator
• Kenya Ministry of Health: collaborator
• Imperial College London: collaborator
• Emory University: collaborator

Study Sites (1)

Kenya Medical Research Institute

Nairobi, PO Box 54810-00200, Kenya

Location

Related Publications (3)

• 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.

  PMID: 31398204 DERIVED

• 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.

  PMID: 31006575 DERIVED

• 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.

  PMID: 26482774 DERIVED

MeSH Terms

Conditions

Helminthiasis; Nematode Infections; Communicable Diseases; Ancylostomiasis

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hookworm Infections; Strongylida Infections; Secernentea Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rachel L Pullan, PhD

  London School of Hygeiene & Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 25, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

KE (1)