Assessing the Feasibility of Coach Mpilo for Men With TB and HIV

Official title

Assessing the Feasibility of Coach Mpilo for Men With TB and HIV in Eastern Cape, South Africa

Overview

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.

Interventions

• Behavioral Coach Mpilo
  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.

Primary outcome measures

• 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)]

Secondary outcome measures (2)

• 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).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Africa · 1 center

• Desmond Tutu Health Foundation — East London

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. PMID 33493956
• Medina-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. PMID 36218175
• Medina-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. PMID 40474267

Identifiers

NCT: NCT07117370 · R34HL170819 · R34HL170819

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗