Community-based Tuberculosis Tracing and Preventive Therapy
NCT03832023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1400
Last updated 2023-02-16
Summary
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.
Conditions
Interventions
- OTHER
-
Screening and initiating preventive therapy in communities
Symptom-based screening of tuberculosis household child contacts by community health workers; initiation of preventive therapy (3 months of a fixed-dose combination of rifampicin-isoniazid or 6 months isoniazid for HIV+ children on protease inhibitors) in the household by a nurse; follow-up of children under preventive therapy by a community health worker for eligible children at community level, and referral of presumptive tuberculosis cases (children and adults) to the facility.
Sponsors & Collaborators
-
Epicentre
collaborator OTHER -
University of Sheffield
collaborator OTHER -
Institut de Recherche pour le Developpement
collaborator OTHER_GOV -
Elizabeth Glaser Pediatric AIDS Foundation
lead OTHER
Principal Investigators
-
Boris Tchounga, MD, PHD · Elisabeth Glaser Pediatric AIDS Foundation
-
Daniel Atwine, MD, PhD · Epicentre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-14
- Primary Completion
- 2022-08-01
- Completion
- 2022-08-01
Countries
- Cameroon
- Uganda
Study Locations
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