NCT07117370: Coach Mpilo

Assessing the Feasibility of Coach Mpilo for Men With TB and HIV

Recruiting now NA Last updated 12 August 2025

What this trial tests

NA trial testing Coach Mpilo in Tuberculosis in 240 participants. Currently enrolling.

Timeline

1 June 2024

Primary endpoint
31 August 2026

31 August 2026

Quick facts

Lead sponsor	Arizona State University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	1 June 2024
Primary completion	31 August 2026
Estimated completion	31 August 2026
Sites	1 location across South Africa

Drugs / interventions tested

• Coach Mpilo

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →
• HIV — all drugs for HIV →

Sponsor

Arizona State University

Who can join

18 and older, male only, with Tuberculosis or HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Men are less likely to report TB-related symptoms, get diagnosed, smear convert, or complete treatment, suggesting that outcomes along the TB cascade are worse for men. Despite men's greater burden of TB and poorer treatment outcomes, no interventions have been developed to address these gendered disparities. Building on our preliminary research that identified men's preferences for a TB care support intervention, we identified Coach Mpilo (CM), a peer-support HIV treatment intervention that was developed by men for men in South Africa, and tailored for men TB infection. The aims of our study are to assess the feasibility of CM for men and assess secondary outcomes for treatment completion and HIV viral suppression to inform a Hybrid Type I intervention. In Aim 1, CM will be further tailored to men initiating TB treatment (CM-TB) and for with HIV co-infection (CM-TB/HIV). Using a mixed methods approach guided by ADAPT-IIT model, we will conduct interviews, CM simulations, and a pre-test to assess men's usability of CM-TB and CM-TB/HIV in this setting. We will conduct Aims 2 and 3 concurrently. In Aim 2, CM-TB will be evaluated to assess feasibility among men and secondary outcomes for retention in care and successful TB treatment (TBT) outcomes. Using a randomized controlled trial design, men (N=120) initiating TBT will be randomized to receive CM or clinic-based standard of care adherence support. The primary outcome is feasibility, acceptability, willingness and safety for men with secondary outcomes for completing TBT within 180 days per arm. In Aim 3, the feasibility of CM-TB/HIV for men (n=120) co-infected with TB and HIV will be assessed. The primary outcome is feasibility, acceptability, willingness and safety with secondary outcomes measured for proportion of men adherent to anti-retroviral therapy at TBT completion and with a suppressed viral (SVL) load 6 months post-ART initiation and post-TBT completion per study arm. If shown to be feasible, we will propose an randomized controlled trial to assess effectiveness in improving men's TB and HIV outcomes and adapted to improve men's health in the context of non-communicable diseases in South Africa and globally.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.