Peer Navigation for HIV Prevention
(MATCH Trial)
Recruiting in Palo Alto (17 mi)
Overseen byTiara C. Willie, PhD, MA
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins Bloomberg School of Public Health
Disqualifiers: Non-English speaking, currently living with HIV
Trial Summary
What is the purpose of this trial?
U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Peer Navigation Group treatment for HIV prevention?
Research shows that peer navigation programs can help people with HIV stay engaged in care and adhere to treatment by providing social support and addressing barriers like stigma. These programs have been effective in improving care engagement and treatment adherence, which are crucial for HIV prevention.12345
Is peer navigation for HIV prevention safe for humans?
How is the Peer Navigation Group treatment for HIV prevention different from other treatments?
The Peer Navigation Group treatment is unique because it uses trained peers to guide and support individuals at risk of HIV, helping them access prevention services like pre-exposure prophylaxis (PrEP). This approach focuses on social support and personalized guidance, which can improve engagement in care and adherence to prevention strategies, unlike traditional medical treatments that rely solely on healthcare providers.15678
Eligibility Criteria
This trial is for Black women at high risk of HIV, focusing on those who have faced intimate partner violence and gendered racism. It aims to help them start using pre-exposure prophylaxis (PrEP) for HIV prevention.Inclusion Criteria
I have never taken PrEP medication.
I have had unprotected sex with a male partner in the last 6 months.
I am a Black cisgender woman.
See 3 more
Exclusion Criteria
Non-English speaking
Currently living with HIV
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive 4 weekly group sessions and 4 one-on-one sessions with a peer navigator
4 weeks
4 group sessions, 4 one-on-one sessions
Control
Participants receive a single group session
1 day
1 group session
Follow-up
Participants are monitored for PrEP initiation and adherence
6 months
Assessments at 2, 4, and 6 months post-randomization
Treatment Details
Interventions
- Peer Navigation Group (Behavioral Intervention)
Trial OverviewThe study tests a multilevel intervention that includes peer navigation support to increase the initiation of PrEP among Black women in Baltimore, both with and without experiences of domestic violence.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention Group (Peer Navigation)Experimental Treatment1 Intervention
Participants randomized to this arm will receive 4 weekly group sessions and 4 one-on-one sessions with a peer navigator
Group II: Control GroupPlacebo Group1 Intervention
Participants randomized to this group will receive a single group session
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins Bloomberg School of Public HealthBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
A Scoping Review of Peer Navigation Programs for People Living with HIV: Form, Function and Effects. [2022]This scoping review maps recent research into peer navigation programs for people living with HIV. Four databases were systematically searched in June 2020. Results were screened according to defined criteria and were not restricted to any design, outcome or country. Six papers drew from randomised control trials, five from quasi-experimental or pragmatic trials, and four panel, eight qualitative, three mixed method and one cross-sectional designs were included for review. Programs incorporated health systems navigation and social support. Authors provided strong theoretical bases for peers to enhance program effects. Studies primarily reported program effects on continuum of care outcomes. Further research is required to capture the role HIV peer navigators play in preventing disease and promoting quality of life, mental health, and disease self-management in diverse settings and populations. Peer programs are complex, social interventions. Future work should evaluate detailed information about peer navigators, their activities, the quality of peer engagement as well as employee and community support structures to improve quality and impact.
Development and pilot testing of a standardized training program for a patient-mentoring intervention to increase adherence to outpatient HIV care. [2021]Although peer interventionists have been successful in medication treatment-adherence interventions, their role in complex behavior-change approaches to promote entry and reentry into HIV care requires further investigation. The current study sought to describe and test the feasibility of a standardized peer-mentor training program used for MAPPS (Mentor Approach for Promoting Patient Self-Care), a study designed to increase engagement and attendance at HIV outpatient visits among high-risk HIV inpatients using HIV-positive peer interventionists to deliver a comprehensive behavioral change intervention. Development of MAPPS and its corresponding training program included collaborations with mentors from a standing outpatient mentor program. The final training program included (1) a half-day workshop; (2) practice role-plays; and (3) formal, standardized patient role-plays, using trained actors with "real-time" video observation (and ratings from trainers). Mentor training occurred over a 6-week period and required demonstration of adherence and skill, as rated by MAPPS trainers. Although time intensive, ultimate certification of mentors suggested the program was both feasible and effective. Survey data indicated mentors thought highly of the training program, while objective rating data from trainers indicated mentors were able to understand and display standards associated with intervention fidelity. Data from the MAPPS training program provide preliminary evidence that peer mentors can be trained to levels necessary to ensure intervention fidelity, even within moderately complex behavioral-change interventions. Although additional research is needed due to limitations of the current study (e.g., limited generalizability due to sample size and limited breadth of clinical training opportunities), data from the current trial suggest that training programs such as MAPPS appear both feasible and effective.
Peer Support and the HIV Continuum of Care: Results from a Multi-Site Randomized Clinical Trial in Three Urban Clinics in the United States. [2022]Racial/ethnic minorities living with HIV and behavioral health co-morbidities are more likely to be disengaged from HIV primary care. Peer programs have been effective in HIV outreach and prevention but effectiveness of such programs for retention in care and viral suppression is understudied. Subjects (n = 348) were randomized in equal allocation to a peer navigation and education intervention versus standard clinical care at three urban clinics in the United States. The intervention group received seven structured interventions plus weekly contact to address medical and social needs. Primary outcomes included time-to-first 4-month gap in HIV care and viral suppression up to 12 months of follow-up. Intention-to-treat analysis showed no difference between groups on 4-month gap in HIV primary care, but subgroup analysis showed a suggestive effect of the peer intervention in reducing gaps in care among stably housed subjects. Fully compliant subjects in the peer intervention experienced significantly fewer 4-month gaps in HIV primary care (p
Revealing an enabling environment: How clinical community and clinical stakeholders understand peer navigation to improve quality of life for people living with HIV in Australia. [2023]People living with HIV have unique resources to offer each other and health systems. This study investigated how peer navigation might contribute to a socially supportive, health enabling environment in Victoria, Australia. We used semi-structured interviews with 30 program staff, management, peer workers and clinician stakeholders. Our analyses considered the interplay between the program, users, HIV-related stigma and discrimination and the health service environment. Peer relationships offered reassurance, acceptance and belonging, which people living with HIV can use to create personal change. Peer engagement coproduced insights for life with HIV and may help to overcome stigma and structural barriers to access services and community support. As a partnership between peer and clinical services, participants described how the program fostered appreciation of peer practices and insights, which were used to improve the quality and continuity of care offered in the state. These findings allude to the value of the community engagement and policy alignment peer responses produce and can be used to guide implementation of similar programs elsewhere.
Engaging HIV-positive clients in care: acceptability and mechanisms of action of a peer navigation program in South Africa. [2019]Antiretroviral therapy (ART) could curtail the HIV epidemic, but its impact is diminished by low uptake. We developed a peer navigation program to enhance engagement in HIV care, ART adherence, and behavioral prevention. In preparation for a randomized controlled trial, the program was piloted over four months at two primary health clinics in South Africa's North West Province. Newly diagnosed, HIV-positive clients met regularly with navigators to address barriers to care, adherence, and prevention. To assess program acceptability and feasibility and characterize the mechanisms of action, we surveyed 25 clients who completed navigation services and conducted interviews with 10 clients, four navigators, and five clinic providers. Clients expressed near universal approval for the program and were satisfied with the frequency of contact with navigators. HIV stigma emerged as a primary driver of barriers to care. Navigators helped clients overcome feelings of shame through education and by modeling how to live successfully with HIV. They addressed discrimination fears by helping clients disclose to trusted individuals. These actions, in turn, facilitated clients' care engagement, ART adherence, and HIV prevention efforts. The findings suggest peer navigation is a feasible approach with potential to maximize the impact of ART-based HIV treatment and prevention strategies.
Exploring peer navigation and support in the quality of HIV care experiences of female sex workers in the Dominican Republic. [2022]Despite evidence on peer navigation's association with positive HIV outcomes, such as engagement in HIV care and antiretroviral therapy (ART) initiation, the mechanisms through which peer navigation may influence these outcomes have been less explored. The purpose of this study is to describe the role of peer navigation and support on enhancing the quality of HIV treatment and care services experienced by female sex workers (FSWs).
What's PrEP?: peer navigator acceptability among minority MSM in Washington. [2022]Peer navigation is a promising strategy to link at-risk minority men who have sex with men (MSM) to HIV prevention services including pre-exposure prophylaxis (PrEP).
Leveraging peer-based support to facilitate HIV care in Kenya. [2018]Rakhi Karwa and colleagues discuss a program in which peer navigators support care for people with HIV at a Kenyan hospital.