Feasibility Study of Coach Mpilo Peer Support for Men with Tuberculosis and HIV in Eastern Cape, South Africa
Led by Arizona State University · Updated on 2025-08-12
240
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Men tend to have worse outcomes throughout the tuberculosis TB care process, including less symptom reporting, diagnosis, and treatment completion, especially when also living with HIV. This research evaluates the feasibility of Coach Mpilo CM, a peer-support intervention originally designed to help men with HIV, adapted here for men with TB and TBHIV co-infection. The study aims to assess how well this coaching model works for men starting TB treatment and for those co-infected with HIV, focusing on treatment completion and viral suppression as key outcomes.
The study includes two main groups men beginning TB treatment who receive either the CM peer support or usual clinic-based care, and men co-infected with TB and HIV who receive the adapted CM support or standard care. The CM intervention involves trained peer coaches with personal experience in TB and HIV treatment providing support and guidance to help men stay on their treatment plans. Participants will be randomized to either the CM support or standard care in a controlled trial.
Participants will be followed through their TB treatment and beyond, with assessments of how feasible, acceptable, and safe the CM intervention is for men. Researchers will measure TB treatment completion within 180 days and, for those with HIV, adherence to antiretroviral therapy and viral load suppression up to 210 days. The study involves interviews, simulations, and monitoring of treatment progress to gather data on outcomes and inform future larger trials. Total participation lasts through treatment and follow-up periods of about 6 to 7 months.
CONDITIONS
Brief Title
Assessing the Feasibility of Coach Mpilo for Men With TB and HIV
Research Team
J
Joseph Daniels
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Newly starting or restarting tuberculosis treatment after being lost from care according to South African guidelines
Living in BCM Health Districts
Able to provide written informed consent
For the TB/HIV group: must be HIV-positive and not currently on antiretroviral therapy
You will not qualify if you...
Not male
Under 18 years of age
Not initiating or re-initiating tuberculosis treatment after loss from care
Not living in BCM Health Districts
Unable to provide written informed consent
For the TB/HIV group: HIV-negative or currently on antiretroviral therapy
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - Up to 210 days
Participants receive peer support through trained coaches to help navigate and stay on tuberculosis and HIV treatment, or standard care involving treatment education and scheduled treatment pick up dates.
Regular visits for treatment and support as scheduled by the study team
Follow-up
Duration - Up to 180 days after enrollment for some outcomes
Participants are monitored following the end of treatment to assess treatment completion and intervention feasibility.
Visits as scheduled for follow-up assessments
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Social isolation, social exclusion, and access to mental and tangible resources: mapping the gendered impact of tuberculosis-related stigma among men and women living with tuberculosis in Eastern Cape Province, South Africa.
Andrew Medina-Marino, Lindsey de Vos, Joseph Daniels