Masculinity, resources, and retention in care: South African men's behaviors and experiences while engaged in TB care and treatment.
Joseph Daniels, Andrew Medina-Marino, Katherine Glockner...
https://pubmed.ncbi.nlm.nih.gov/33493956Actively Recruiting
Phase Not Applicable
Age: 18Years +
MALE
ID07117370
Assessing the Feasibility of Coach Mpilo for Men With TB 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
On this page
Sponsors
A
Arizona State University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
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 TB/HIV 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
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Men aged 18 years or older
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Desmond Tutu Health Foundation
East London, South Africa
Actively Recruiting
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Research Team
J
Joseph Daniels
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
Qualitative Identification of Intervention Preferences to Support Men's Engagement and Retention in TB Care in South Africa.
Andrew Medina-Marino, Dana Bezuidenhout, Nondumiso Ngcelwane...
https://pubmed.ncbi.nlm.nih.gov/36218175Social 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
https://pubmed.ncbi.nlm.nih.gov/40474267