Coach Mpilo peer support for men with TB and HIV
Assessing the Feasibility of Coach Mpilo for Men With TB and HIV in Eastern Cape, South Africa
We will test whether Coach Mpilo, a peer-support program developed by men, helps men starting TB treatment — including those with HIV — complete TB therapy and achieve better HIV viral suppression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Arizona State University Academic / other |
| Locations | 1 site (East London) |
| Trial ID | NCT07117370 on ClinicalTrials.gov |
What this trial studies
This project will adapt the Coach Mpilo peer-support model for men initiating TB treatment and for men with TB/HIV co-infection, creating CM-TB and CM-TB/HIV versions. Using the ADAPT-IIT model and a mixed-methods approach, investigators will conduct interviews, role simulations, and a small pre-test/pilot to refine the intervention. Subsequent implementation will enroll men initiating or re-initiating TB therapy in Buffalo City Metro (BCM) Health Districts to measure feasibility and collect secondary outcomes on TB treatment completion and HIV viral suppression. Findings will inform a later Hybrid Type I implementation-effectiveness effort.
Who should consider this trial
Good fit: Men aged 18 or older who live in BCM Health Districts and are newly starting or re-starting TB treatment, and for the HIV-focused arm those who are HIV-positive and not yet on ART, are the ideal candidates.
Not a fit: Women, people under 18, those living outside the BCM districts, and people who are not initiating or re-initiating TB treatment (or who are already on ART for the HIV arm) are not eligible and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this peer-support approach could increase TB treatment completion and improve HIV viral suppression among men, reducing morbidity and onward transmission.
How similar studies have performed: Coach Mpilo has been used as a peer-support HIV treatment intervention for men in South Africa with prior positive signals for improving HIV outcomes, but its adaptation specifically for TB/HIV is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Aim 2: 1) men; 2) aged ≥18 years; 3) newly initiating (i.e., treatment naive) or re-initiating TBT after being loss-from-care per South African national guidelines; 4) live in BCM Health Districts; and 5) provide written informed consent. Aim 3: 1) men; 2) aged ≥18 years; 3) newly initiating (i.e., treatment naive) or re-initiating TBT after being loss-from-care per South African national guidelines; 4) HIV-positive; 5) Not on ART, 6) live in BCM Health Districts; and 7) provide written informed consent. Exclusion Criteria: Aim 2: 1) Not a man; 2) aged \< 18 years; 3) not initiating (i.e., treatment naive) or not re-initiating TBT after being loss-from-care per South African national guidelines; 4) not live in BCM Health Districts; and 5) cannot provide written informed consent. Aim 3: 1) Not a man; 2) aged \< 18 years; 3) not initiating (i.e., treatment naive) or not re-initiating TBT after being loss-from-care per South African national guidelines; 4) not HIV-positive; 5) on ART, 6) not live in BCM Health Districts; and 7) cannot provide written informed consent.
Where this trial is running
East London
- Desmond Tutu Health Foundation — East London, South Africa (Recruiting)
Study contacts
- Study coordinator: Joseph Daniels
- Email: Joseph.A.Daniels@asu.edu
- Phone: 206-459-5777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.