The Coach Mpilo Study: evaluation of a peer-led intervention to promote engagement in HIV care for men living with HIV in South Africa

Last registered on January 05, 2026

Pre-Trial

Trial Information

General Information

Title
The Coach Mpilo Study: evaluation of a peer-led intervention to promote engagement in HIV care for men living with HIV in South Africa
RCT ID
AEARCTR-0017031
Initial registration date
October 27, 2025

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
October 31, 2025, 8:06 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
January 05, 2026, 6:41 AM EST

Last updated is the most recent time when changes to the trial's registration were published.

Locations

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Primary Investigator

Affiliation
Jameel Latif Abdul Poverty Action Lab

Other Primary Investigator(s)

PI Affiliation
University of Cape Town
PI Affiliation
University of Pennsylvania

Additional Trial Information

Status
In development
Start date
2026-04-01
End date
2027-12-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Developed in South Africa using extensive input from community members and healthcare professionals, Coach Mpilo is a peer support intervention that was designed to improve health outcomes for men living with HIV. Coach Mpilo engages men living with HIV as coaches who provide support to their peers and help them address psychosocial barriers in accessing and staying in HIV care.

The peers employed by Coach Mpilo provide individualized assistance to men who are struggling with medication adherence and clinic visits, focusing on specific barriers ranging from knowledge about the benefits of HIV treatment, stigma, mental health, and social isolation.

Through a randomised control trial, this project will (1) determine the impact of the Coach Mpilo intervention on retention in HIV care, viral suppression, HIV treatment adherence, mental health, HIV stigma, and economic status; (2) identify populations of men who may not benefit from the intervention and require alternative support; and (3) assess the intervention’s cost-effectiveness.
External Link(s)

Registration Citation

Citation
da Silva, Laura, Brendan Maughan-Brown and Harsha Thirumurthy. 2026. "The Coach Mpilo Study: evaluation of a peer-led intervention to promote engagement in HIV care for men living with HIV in South Africa." AEA RCT Registry. January 05. https://doi.org/10.1257/rct.17031-2.0
Experimental Details

Interventions

Intervention(s)
Created by Population Services International (PSI) and Matchboxology, Coach Mpilo employs ‘coaches’ (a term found to resonate in formative research with men and the concept of ‘getting back in the game’) to work 1-on-1 with men living with HIV (‘players’) and tailor support for each man to help him re-engage and stay in care. Coaches provide support for a period of up to six months, during which they engage with clients about once every week, with greater contact as needed based on the complexity of challenges faced.
Intervention Start Date
2026-04-15
Intervention End Date
2027-12-31

Primary Outcomes

Primary Outcomes (end points)
Retention in HIV care at 12 months
Primary Outcomes (explanation)
Retention in HIV care at 12 months is defined as attending a follow-up clinic visit on or before 12 months and obtaining adequate ART refills for a supply of medications at 12 months post study enrolment.

Secondary Outcomes

Secondary Outcomes (end points)
Retention in care at 6 months and viral suppression (<50 copies/ml) at 6 and 12 months.
Secondary Outcomes (explanation)
Secondary outcomes include retention in care at 6 months; viral suppression (<50 copies/ml) at 6 and 12 months; and adherence over 6 and 12 months using proportion of days covered (PDC). In addition, we will examine outcomes measured in the 6-month follow-up survey: HIV-status disclosure, mental health, internalized stigma, self-esteem, employment and social isolation.

Experimental Design

Experimental Design
In partnership with the Department of Health in KwaZulu-Natal Province, HST and Matchboxology, a South African organisation that designs health and social programs, we will conduct a randomised controlled trial (RCT) with men living with HIV who have dropped out of HIV care (i.e., having missed a clinic appointment by >28 days).

Recruitment to the study will occur in parallel to the delivery of the standard of care (SOC) to men disengaged from HIV treatment. To be included in the study men living with HIV must meet the following criteria: (a) aged ≥18 years; (b) previously receiving HIV care at the study clinic; (c) missed their most recent ART clinic appointment by >28 days, (d) not planning to relocate to another region within the next 12 months; (e) able and willing to provide informed consent; (f) not currently taking ART. Importantly, agreement to be contacted by a coach (if selected) is not an eligibility criterion as our goal is to obtain generalizable evidence of the overall effectiveness of the Coach Mpilo program.

Data collection includes baseline and six-month follow-up surveys, extraction of clinical outcomes from electronic health records, and logbooks maintained by peer mentors documenting participant engagement. The primary outcome of interest is retention in HIV care at twelve months, defined as attendance at a follow-up clinic visit and adequate ART refills within the twelve-month period following enrolment. Secondary outcomes include retention at six months, viral suppression, adherence to ART, and psychosocial indicators such as internalised stigma, self-efficacy, and social support.
Experimental Design Details
Not available
Randomization Method
Following the baseline survey, participants will be randomized (1:1) to a control group that receives the SOC and an intervention group that receives SOC plus the Coach Mpilo intervention. This randomization is performed by a computer.
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
~800 men
Sample size: planned number of observations
~800 men
Sample size (or number of clusters) by treatment arms
total sample of ~800 men with ~400 men assigned to control and ~400 men assigned to treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
The University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
IRB Approval Date
2025-12-19
IRB Approval Number
HREC REF 915/2025
Analysis Plan

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