About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
not meeting inclusion criteria
Trial design
Parallel
Treatments tested in this trial
Coach Mpilo
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
ART clinic visit by 6 months
Indicates whether an participant attends an antiretroviral therapy (ART) related clinic visit within 6 months of study enrolment
Retention in HIV care at 6 months
Indicates whether a participant attended a follow-up clinic visit on or before 6 months after study enrolment and obtained adequate supply of antiretroviral therapy (ART) medication to have medication available at 6 month
Viral load test completed at 6 months
Indicates whether a participant completed an HIV viral load test within 6 months of study enrolment
Viral suppression at 6 months
Indicates whether a participant had a viral load test conducted between 3-9 months after study enrolment and the test result was an HIV viral load \<50 copies/ml
Sponsors and contacts
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University of Cape Town
Lead sponsor
University of Pennsylvania
Collaborator
University of Witwatersrand, South Africa
Collaborator
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