Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Coach Mpilo peer support for men with TB and HIV

Official title: Assessing the Feasibility of Coach Mpilo for Men With TB and HIV in Eastern Cape, South Africa

Run by Arizona State University · NCT07117370 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment240 (estimated)
SponsorArizona State University
Academic / other
Locations1 site (East London)
StatusRecruiting
StartedJune 1, 2024
Main results expectedAugust 31, 2026
Study endsAugust 31, 2026
Registry record updatedAugust 12, 2025
Trial IDNCT07117370 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Desmond Tutu Health Foundation
    East London, South Africa
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.