The Coach Mpilo Study: Evaluation of a Peer-led Intervention to Promote Engagement in HIV Care for Men Living With HIV in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Retention in HIV care
研究概览
简要总结
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.
详细描述
Study setting The study will be conducted in KwaZulu-Natal (KZN), the province in South Africa with the highest adult HIV prevalence: 16%-24% (model estimates), 22% (survey estimates). The study will be conducted in about 13 primary healthcare facilities based in the eThekwini District.
Aim 1: Determine the effects of Coach Mpilo on retention in care among men living with HIV In partnership with the Department of Health in KwaZulu-Natal Province, eThekwini Municipality, The Health Systems Trust (HST) and Matchboxology (a South African organisation that designs health and social programs) a randomised controlled trial (RCT) will be conducted with men living with HIV who have dropped out of HIV care (i.e., having missed a clinic appointment by >28 days).
Recruitment: Study staff will be trained by HST as Linkage Officers. As Linkage Officers, they will contact men who have missed clinic appointments via telephone, encourage return to care, and ask to meet privately at local venues. At the in-person meeting the Linkage Officers will invite eligible participants to enrol in the study.
Consenting process: Written informed consent will be obtained.
Data collection Baseline survey: Study staff will administer a baseline questionnaire to obtain information on, among other things, participants' demographic characteristics, socio-economic status, health behaviour, future outlook, internalized stigma and mental health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •not meeting inclusion criteria
研究组 & 干预措施
Control group
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
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.
干预措施: Coach Mpilo (Behavioral)
结局指标
主要结局
Retention in HIV care
时间窗: 12 months post study enrolment
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
次要结局
- 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)
- HIV status disclosure to sexual partners(6 months post study enrolment)
- Symptoms of mental depression(6 months post study enrolment)
- Mild to severe symptoms of mental depression(6 months post study enrolment)
- Moderate to severe symptoms of mental depression(6 months post study enrolment)
- Symptoms of anxiety(6 months post study enrolment)
- Mild to severe symptoms of anxiety(6 months post study enrolment)
- Moderate to severe symptoms of anxiety(6 months post study enrolment)
- Employment(6 months post study enrolment)
- Internalised stigma(6 months post study enrolment)
研究者
Brendan Maughan-Brown
Chief Research Officer
University of Cape Town