NCT07564193

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable hiv

Timeline
16mo left

Started May 2026

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 11, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 26, 2026

Last Update Submit

April 26, 2026

Conditions

HIV

Keywords

HIVantiretroviral therapy (ART)re-engagement in HIV carelinkage to carepeer-supportCoach Mpilomen living with HIVSouth AfricaARV

Outcome Measures

Primary Outcomes (1)

  • Retention in HIV care

    Indicates whether a participant attended a follow-up clinic visit on or before 12 months after study enrolment and obtained adequate supply of antiretroviral therapy (ART) medication to have medication available at 12 months

    12 months post study enrolment

Secondary Outcomes (14)

  • ART clinic visit by 6 months

    6 months post study enrolment

  • Retention in HIV care at 6 months

    6 months post study enrolment

  • Viral load test completed at 6 months

    6 months post study enrolment

  • Viral suppression at 6 months

    3 to 9 months post study enrolment

  • Viral suppression at 12 months

    9 to 15 months post study enrolment

  • +9 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Standard of care (SOC) in our study is a once-off telephonic contact by a Study Linkage Officer to encourage the participant to return to HIV care. The Linkage Officer is trained to conduct the call in line with the South African National Guidelines on tracing and recall which involved making telephonic contact with an individual who has missed their HIV clinic appointment by 7 days. The National Guidelines for tracing also include a potential home visit if the telephone call is unsuccessful. Given our study sample is limited to men who have missed HIV clinic appointments by more than 28 days, all participants should already have received the standard tracing services provided by the health facility. In the study we conduct the tracing telephone call again to make sure all participants have received this service. No other intervention is provided.

Coach Mpilo group

EXPERIMENTAL

The experimental group receives the standard of care for the control group (see control group description) and the Coach Mpilo intervention. Coach Mpilo employs 'coaches' (a term found to resonate 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. Coach Mpilo provides one-on-one, in-person support tailored to the individual needs of men living with HIV. As such, it may address the complex and varying psychosocial barriers to HIV care that traditional clinic-based interventions typically overlook. Coach Mpilo employs men living openly with HIV as coaches. This leverages the coaches' personal experiences to create a safe and supportive environment for clients.

Behavioral: Coach Mpilo

Interventions

Coach MpiloBEHAVIORAL

The experimental group receives the standard of care for the control group (see control group description) and the Coach Mpilo intervention. Coach Mpilo employs 'coaches' (a term found to resonate 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. Coach Mpilo provides one-on-one, in-person support tailored to the individual needs of men living with HIV. As such, it may address the complex and varying psychosocial barriers to HIV care that traditional clinic-based interventions typically overlook. Coach Mpilo employs men living openly with HIV as coaches. This leverages the coaches' personal experiences to create a safe and supportive environment for clients.

Coach Mpilo group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale (cisgender or transgender)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male (cisgender or transgender);
  • aged ≥18 years;
  • previously receiving HIV care at the study clinic;
  • missed their most recent ART (antiretroviral therapy) clinic appointment by \>28 days;
  • not planning to relocate to another region within the next 12 months;
  • able and willing to provide informed consent;
  • not currently taking ART

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multisite study with several health care facilities

Durban, KwaZulu-Natal, South Africa

Location

Related Links

Study Officials

  • Brendan G Maughan-Brown, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

  • Harsha Thirumurthy, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brendan G Maughan-Brown, PhD

CONTACT

+27216505696brendan.maughan-brown@uct.ac.za

Harsha Thirumurthy, PhD

CONTACT

hthirumu@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Research Officer

Study Record Dates

First Submitted

April 26, 2026

First Posted

May 4, 2026

Study Start (Estimated)

May 11, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Survey data and in-depth interview data; excluding personal identifying information

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be made publicly available through DataFirst within 12 months from the data collection for the study
Access Criteria
Data will be available through DataFirst. Individuals who successfully register with DataFirst will have access. There are no specific exclusion criteria

Locations

ZA(1)