TuberculosisCoach MpiloNCT07117370
Assessing the Feasibility of Coach Mpilo for Men With TB and HIV
A study testing Coach Mpilo in people with Tuberculosis and HIV, run by Arizona State University at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Tuberculosis, HIV
- What is being tested?
- Coach Mpilo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jun 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Desmond Tutu Health Foundation
East London
Andrew Medina-Marino, 27 71 515 3785, amedinam@upenn.edu
Andrew Medina-Marino
About this study
Official title: Assessing the Feasibility of Coach Mpilo for Men With TB and HIV in Eastern Cape, South Africa
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.
- Conditions
- Tuberculosis, HIV
- Being tested
- Coach Mpilo
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coach MpiloBehavioural
Peer support for treatment navigation. Peer supporters (coaches) with TB and HIV treatment experiences are trained in listening, support, and action planning to assist men in navigating and staying on treatment.
| Study group | Role | What they receive |
|---|---|---|
| Coach Impilo | Experimental | Peer support for TB and HIV treatment Receives: Behavioral: Coach Mpilo |
| Standard of Care | No intervention | Standard of care is treatment education and scheduled treatment pick up dates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Qualitative and quantitative assessment using interviews and surveys to evaluate intervention feasibility, acceptability, willingness and safety.
Measured: From enrollment to the end of treatment and follow up at 180 days (Aim 2) From enrollment to the end of treatment and follow up at 210 days (Aim 3)
Secondary outcomes (2)
TB treatment completion
Monthly medical record review of TB treatment pick-up.
Measured: From enrollment to intervention and follow-up at 180 days (Aim 2)
HIV treatment
Medical chart review of antiretroviral therapy pick-up and viral load.
Measured: From enrollment to the end of intervention and follow-up at 210 days (Aim 3 only).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Jun 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117370
- Sponsor's protocol ID
- R34HL170819
- Other IDs
- R34HL170819
- Acronym
- Coach Mpilo
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daniels J, Medina-Marino A, Glockner K, Grew E, Ngcelwane N, Kipp A. Masculinity, resources, and retention in care: South African men's behaviors and experiences while engaged in TB care and treatment. Soc Sci Med. 2021 Feb;270:113639. doi: 10.1016/j.socscimed.2020.113639. Epub 2021 Jan 23.
PubMed 33493956Medina-Marino A, Bezuidenhout D, Ngcelwane N, Cornell M, Wainberg M, Beyrer C, Bekker LG, Daniels J. Qualitative Identification of Intervention Preferences to Support Men's Engagement and Retention in TB Care in South Africa. Am J Mens Health. 2022 Sep-Oct;16(5):15579883221129349. doi: 10.1177/15579883221129349.
PubMed 36218175Medina-Marino A, de Vos L, Daniels J. 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. BMC Glob Public Health. 2025 Jun 5;3(1):50. doi: 10.1186/s44263-025-00166-6.
PubMed 40474267
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Coach Mpilo for Men With TB and HIV in Eastern Cape, South Africa
- ClinicalTrials.gov ID
- NCT07117370
- Acronym / sponsor ID
- Coach Mpilo / R34HL170819
- Conditions
- Tuberculosis, HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coach Impilo | Experimental | Behavioral: Coach MpiloPeer support for TB and HIV treatment |
| Standard of Care | No intervention | –Standard of care is treatment education and scheduled treatment pick up dates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coach MpiloPeer support for treatment navigation. Peer supporters (coaches) with TB and HIV treatment experiences are trained in listening, support, and action planning to assist men in navigating and staying on treatment. | Behavioural | Coach Impilo |
Primary outcome
Intervention Feasibility
Time frame: From enrollment to the end of treatment and follow up at 180 days (Aim 2) From enrollment to the end of treatment and follow up at 210 days (Aim 3)
Qualitative and quantitative assessment using interviews and surveys to evaluate intervention feasibility, acceptability, willingness and safety.
2 secondary outcomes
TB treatment completion
Time frame: From enrollment to intervention and follow-up at 180 days (Aim 2)
HIV treatment
Time frame: From enrollment to the end of intervention and follow-up at 210 days (Aim 3 only).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Results publication: PubMed 33493956Daniels J, Medina-Marino A, Glockner K, Grew E, Ngcelwane N, Kipp A. Masculinity, resources, and retention in care: South African men's behaviors and experiences while engaged in TB care and treatment. Soc Sci Med. 2021 Feb;270:113639. doi: 10.1016/j.socscimed.2020.113639. Epub 2021 Jan 23.
- Results publication: PubMed 36218175Medina-Marino A, Bezuidenhout D, Ngcelwane N, Cornell M, Wainberg M, Beyrer C, Bekker LG, Daniels J. Qualitative Identification of Intervention Preferences to Support Men's Engagement and Retention in TB Care in South Africa. Am J Mens Health. 2022 Sep-Oct;16(5):15579883221129349. doi: 10.1177/15579883221129349.
- Results publication: PubMed 40474267Medina-Marino A, de Vos L, Daniels J. 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. BMC Glob Public Health. 2025 Jun 5;3(1):50. doi: 10.1186/s44263-025-00166-6.
- Individual participant dataSharing planned: No
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coach Mpilo in people with Tuberculosis and HIV, run by Arizona State University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Daniels (206-459-5777, Joseph.A.Daniels@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility (time frame: From enrollment to the end of treatment and follow up at 180 days (Aim 2) From enrollment to the end of treatment and follow up at 210 days (Aim 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07117370, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.