Clinical trial NCT05917210: Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
Official title: Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tuberculosis
HIV
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-06-23
Enrollment: 1920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Effectiveness assessed by TB treatment completion
timeFrame: up to 8 months post TB treatment initiation
measure: Effectiveness assessed by Antiretroviral Therapy (ART) retention
timeFrame: month 12 post ART initiation
Secondary outcomes:
measure: Clinical Effectiveness assessed by TB recurrence-free survival
timeFrame: month 6 post TB-treatment
measure: Clinical Effectiveness assessed by HIV RNA copy number
timeFrame: month 12 post ART initiation
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Primary Care Clinics
Study officials:
affiliation: Yale University
name: J. Lucian Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: