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

Study Overview
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Brief Summary
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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
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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: Process evaluation of intervention fidelity to quantify the adoption, reach, implementation, and maintenance of the peer navigation strategy, In-depth interviews with people with Tuberculosis (PWTB) with and without HIV, In-depth interviews with and direct observation of peer navigators, and Focus-group discussions (FGDs) with healthcare workers. The focus of this registration is Aim 1 and 2.

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

Conditions
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Tuberculosis, HIV

Intervention / Treatment
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* Behavioral: Standard TB-EC
* Behavioral: Peer navigation strategy for TB-EC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer navigation strategy for TB Education and Counseling (TB-EC)<br>peer-navigation strategy for TB-EC in adults and adolescents with and without HIV starting TB treatment at clinics in Uganda | Behavioral: Peer navigation strategy for TB-EC<br>* multi-component, peer-navigation strategy for TB-EC<br>|
| Active Comparator: Standard TB-EC<br>standard TB-EC in adults and adolescents with and without HIV starting TB treatment at clinics in Uganda | Behavioral: Standard TB-EC<br>* Standard TB-EC by healthcare workers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness assessed by TB treatment completion | 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. | up to 8 months post TB treatment initiation | 
| Effectiveness assessed by Antiretroviral Therapy (ART) retention | 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. | month 12 post ART initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Effectiveness assessed by TB recurrence-free survival | 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. | month 6 post TB-treatment | 
| Clinical Effectiveness assessed by HIV RNA copy number | Clinical Effectiveness assessed by the number of participants with 12-month HIV RNA ≤50 copies/mL. | month 12 post ART initiation |