Project Abstract
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.