NCT03832023: CONTACT

Community-based Tuberculosis Tracing and Preventive Therapy

Completed NA Last updated 16 February 2023

What this trial tests

NA trial testing Screening and initiating preventive therapy in communities in Tuberculosis in 1,400 participants. Completed in 1 August 2022.

Timeline

14 October 2019

Primary endpoint
1 August 2022

1 August 2022

Quick facts

Lead sponsor	Elizabeth Glaser Pediatric AIDS Foundation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	1,400
Start date	14 October 2019
Primary completion	1 August 2022
Estimated completion	1 August 2022
Sites	25 locations across Cameroon, Uganda

Drugs / interventions tested

• Screening and initiating preventive therapy in communities

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Who can join

Eligibility, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The many gaps observed in the cascade of care of tuberculosis (TB) child contacts occur mostly in the screening, preventive therapy (PT) initiation and PT completion steps and the main drivers of these gaps are considered to be the health system infrastructure, limited worker resources and parents' reluctance to bring their children to the facility for screening. There would be great advantages of using a symptom-based screening at community level where only the symptomatic contacts are referred to hospital for further evaluation and asymptomatic contacts are started on PT in the community. Household or community-based screening is likely to improve the uptake and acceptability of child contact screening and management as well as adherence to PT and to reduce cost and workload at facility level.

This study proposes to compare the cascade of care between two models for TB screening and management of household TB child contacts in two high TB burden and limited resource countries, Cameroon and Uganda. In the facility-based model, children will be screened at facility (Cameroon) or household level (Uganda) and preventive therapy initiation, refills of PT therapy and follow-up will be done at facility level. In the intervention group (community-based model), child contacts will be screened in the household by a community health worker (CHW). Those with symptoms suggestive of TB will be referred to the facility for TB investigations. Asymptomatic child contacts from high risk groups (under-5 years or HIV infected 5-14) will be initiated on PT (3 months isoniazid-rifampicin) in the household. Refills of PT therapy will also be done in the communities by the CHW. In both models, symptomatic children requiring further investigations for TB diagnosis will be referred to a health facility.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of a community-based approach for the investigation and management of children with household tuberculosis contact in Cameroon and Uganda: a cluster-randomised trial.
   Bonnet M, Vasiliu A, Tchounga BK, Cuer B, et al · · 2023 · cited 23× · PMID 37918417 · DOI 10.1016/s2214-109x(23)00430-8
2. Feasibility of a randomized clinical trial evaluating a community intervention for household tuberculosis child contact management in Cameroon and Uganda.
   Vasiliu A, Tiendrebeogo G, Awolu MM, Akatukwasa C, et al · · 2022 · cited 8× · PMID 35148800 · DOI 10.1186/s40814-022-00996-3
3. Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial.
   Vasiliu A, Eymard-Duvernay S, Tchounga B, Atwine D, et al · · 2021 · cited 8× · PMID 33653385 · DOI 10.1186/s13063-021-05124-9
4. Cost-effectiveness analysis of interventions to improve diagnosis and preventive therapy for paediatric tuberculosis in 9 sub-Saharan African countries: A modelling study.
   Mafirakureva N, Mukherjee S, de Souza M, Kelly-Cirino C, et al · · 2023 · cited 7× · PMID 37672524 · DOI 10.1371/journal.pmed.1004285
5. Feasibility of a randomized clinical trial evaluating a community intervention for household tuberculosis child contact management in Cameroon and Uganda
   Vasiliu A, Tiendrebeogo G, Awolu MM, Akatukwasa C, et al · · 2021 · DOI 10.21203/rs.3.rs-970700/v1