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

HIV Clinical Trial

— TEACH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05917210
• Other study ID #: 2000035416
• Secondary ID: 1R01HL170926-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2026

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: J. Lucian Davis, MD
• Phone: 203-785-3665
• Email: Lucian.Davis[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1920
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Tuberculosis

Intervention

Behavioral:
• Standard TB-EC
Standard TB-EC by healthcare workers
• Peer navigation strategy for TB-EC
multi-component, peer-navigation strategy for TB-EC

Locations

Country	Name	City	State
Uganda	Primary Care Clinics	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institutes of Health (NIH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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