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

Not Applicable

Not yet recruiting

• Conditions: HIV; Tuberculosis
• Interventions: Behavioral: Peer navigation strategy for TB-EC; Behavioral: Standard TB-EC

• Registration Number: NCT05917210
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Study Start: 2025-09
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1920

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer navigation strategy for TB Education and Counseling (TB-EC)	Peer navigation strategy for TB-EC	peer-navigation strategy for TB-EC in adults and adolescents with and without HIV starting TB treatment at clinics in Uganda
Standard TB-EC	Standard TB-EC	standard TB-EC in adults and adolescents with and without HIV starting TB treatment at clinics in Uganda

Primary Outcome Measures

Name	Time	Method
Effectiveness assessed by TB treatment completion	up to 8 months post TB treatment initiation	The number of participants with TB treatment completion, defined by WHO as attending all refill visits and completing 180 daily doses of standard TB treatment within 8 months of TB treatment initiation, as documented in the on-site TB treatment register.
Effectiveness assessed by Antiretroviral Therapy (ART) retention	month 12 post ART initiation	The number of participants with ART retention, defined as completing all ART refill visits (or refill pickups if enrolled in differentiated models of ART care) and continuing on daily ART 12 months after starting ART, as documented in the on-site ART register.

Secondary Outcome Measures

Name	Time	Method
Clinical Effectiveness assessed by TB recurrence-free survival	month 6 post TB-treatment	Clinical Effectiveness assessed by the number of participants with 6-month post-treatment TB recurrence-free survival. Data collectors at all sites will telephone participants and/or treatment supporters to document TB recurrence-free survival.
Clinical Effectiveness assessed by HIV RNA copy number	month 12 post ART initiation	Clinical Effectiveness assessed by the number of participants with 12-month HIV RNA ≤50 copies/mL.

Trial Locations

Locations (1)

Primary Care Clinics; 🇺🇬 Kampala, Uganda