Assessing the Feasibility of Coach Mpilo for Men With TB and HIV
Launched by ARIZONA STATE UNIVERSITY · Aug 5, 2025
Trial Information
Current as of August 28, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a support program called Coach Mpilo, designed specifically to help men who are being treated for tuberculosis (TB), and in some cases, also living with HIV. Men with TB and HIV often face more challenges in getting diagnosed and completing their treatment compared to women, so this study aims to see if Coach Mpilo can make it easier for men to stay on their treatment and improve their health. The program uses peer support, where men who have experience with these illnesses help others through their treatment journey.
Men who are 18 years or older and starting or restarting TB treatment in certain health districts in South Africa may be eligible to join. For those who also have HIV, they must not yet be on HIV treatment to participate in that part of the study. Participants will be randomly assigned to either receive the Coach Mpilo support or the usual care provided at the clinic. The study will check if men find the program helpful, safe, and easy to use, and will also look at how well they complete their TB treatment and, for those with HIV, how well they manage their HIV treatment over time. This research could lead to better ways to support men with TB and HIV, improving their health outcomes.
Gender
MALE
Eligibility 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.
About Arizona State University
Arizona State University (ASU) is a leading research institution dedicated to advancing knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, ASU leverages its interdisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical research aimed at improving patient outcomes and contributing to the scientific community. With a commitment to ethical research practices and collaboration with healthcare professionals, ASU strives to translate research findings into practical applications that benefit society. The university's focus on community engagement and real-world impact underscores its role as a pivotal player in the advancement of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
East London, , South Africa
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported