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

Yale University

Status: Not yet enrolling

Conditions: Tuberculosis; HIV

Treatments: Behavioral: Peer navigation strategy for TB-EC; Behavioral: Standard TB-EC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05917210

2000035416

1R01HL170926-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,920 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,920 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Behavioral: Peer navigation strategy for TB-EC

Standard TB-EC

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard TB-EC