Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda

NCT ID: NCT05917210

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1920 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2028-03-31

Brief Summary

This cluster-randomized trial in Uganda will evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV/AIDS and assess the social-behavioral mechanisms underlying the observed treatment effects.

Detailed Description

Study Design Aim 1. The investigators will conduct a parallel cluster-randomized hybrid Type 2 effectiveness-implementation trial at 16 sites.

Aim 2. Within the Aim 1 study, the investigators will nest a longitudinal observational study in both arms of the cluster-randomized trial to determine the feasibility, acceptability, and appropriateness of a peer-navigation strategy for TB-EC. The investigators will concurrently assess biological adherence using urine biomarkers) and will also perform a mediation analysis of social and behavioral factors (i.e., TB knowledge, perceived social support, general self-efficacy, HIV/TB stigma) to identify causal mechanisms of impact. Finally, the investigators will pilot and culturally adapt study instruments in a pilot study prior to the trial.

Aim 3. The investigators will also conduct a qualitative and mixed methods studies to assess the implementation fidelity and context of the peer-navigation strategy for TB-EC:

1. Process evaluation of intervention fidelity to quantify the adoption, reach, implementation, and maintenance of the peer navigation strategy,

2. In-depth interviews with people with Tuberculosis (PWTB) with and without HIV,

3. In-depth interviews with and direct observation of peer navigators, and

4. Focus-group discussions (FGDs) with healthcare workers.

The focus of this registration is Aim 1 and 2.

Conditions

Tuberculosis; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Peer navigation strategy for TB Education and Counseling (TB-EC)

peer-navigation strategy for TB-EC in adults and adolescents with and without HIV starting TB treatment at clinics in Uganda

Group Type: EXPERIMENTAL

Peer navigation strategy for TB-EC

Intervention Type: BEHAVIORAL

multi-component, peer-navigation strategy for TB-EC

Standard TB-EC

standard TB-EC in adults and adolescents with and without HIV starting TB treatment at clinics in Uganda

Group Type: ACTIVE_COMPARATOR

Standard TB-EC

Intervention Type: BEHAVIORAL

Standard TB-EC by healthcare workers

Interventions

Standard TB-EC

Standard TB-EC by healthcare workers

Intervention Type: BEHAVIORAL

Peer navigation strategy for TB-EC

multi-component, peer-navigation strategy for TB-EC

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

TB outcomes:

• Sites will enroll consecutive adults and older adolescents (age ≥18) recorded as new TB cases in the on-site National TB Program TB treatment register.

ART outcomes:

• Participants must be documented as a People Living with HIV (PLH) in the TB register.

Exclusion Criteria

TB outcomes: Individuals who are

• transferring in from off-site
• diagnosed with possible or confirmed drug-resistant TB
• residing >40 km from the clinic
• lacking mental capacity to participate in peer counseling

will be excluded from this study.

ART outcomes:

• The investigators will exclude those with TB meningitis or TB pericarditis for which immediate ART is contraindicated; and those with central nervous system TB or TB osteomyelitis because these forms of TB have a different treatment duration.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. Lucian Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Primary Care Clinics

Kampala, , Uganda

Countries

Uganda

Central Contacts

J. Lucian Davis, MD

Role: CONTACT

Lucian.Davis@yale.edu

203-785-3665

Other Identifiers

1R01HL170926-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2000035416

Identifier Type: -

Identifier Source: org_study_id