Peer Navigation for HIV Prevention

(MATCH Trial)

Overseen By Tiara C. Willie, PhD, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Non-English speaking, currently living with HIV

Compensation: Varies

Number of Visits: 7

300 Participants Needed

What You Need to Know Before You Apply

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.

Is peer navigation for HIV prevention safe for humans?

The research on peer navigation programs for HIV prevention does not report any safety concerns, suggesting it is generally safe for humans. These programs focus on providing social support and improving engagement in HIV care, which can enhance the quality of life for people living with HIV. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{2 4 5 7 8}

Who Is on the Research Team?

Tiara C. Willie, PhD, MA

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Non-English speaking

Currently living with HIV

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Peer Navigation Group

Trial Overview The 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.

How Is the Trial Designed?

Group I: Intervention Group (Peer Navigation) Experimental Treatment 1 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 Group Placebo Group 1 Intervention

Participants randomized to this group will receive a single group session

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Peer navigation programs for people living with HIV have shown positive effects on the continuum of care outcomes, as evidenced by a review of various study designs including randomized control trials and qualitative studies.

Further research is needed to better understand the specific roles of peer navigators in improving health outcomes, mental health, and self-management for individuals with HIV, highlighting the complexity and social nature of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Peer Navigation Programs for People Living with HIV: Form, Function and Effects. Krulic, T., Brown, G., Bourne, A.[2022]

The MAPPS training program successfully trained HIV-positive peer mentors to effectively deliver a comprehensive behavioral change intervention aimed at increasing engagement in HIV care, demonstrating both feasibility and effectiveness.

Mentors rated the training program highly, and objective assessments showed they could meet the necessary standards for intervention fidelity, indicating that peer-led approaches can be a valuable strategy in promoting patient self-care in HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot testing of a standardized training program for a patient-mentoring intervention to increase adherence to outpatient HIV care. Cully, JA., Mignogna, J., Stanley, MA., et al.[2021]

A study involving 348 participants found that a peer navigation and education intervention did not significantly reduce gaps in HIV primary care overall, but it showed promise for stably housed individuals, who experienced fewer gaps when fully compliant with the program.

While the peer intervention did not lead to significant differences in viral suppression at 12 months, it highlighted the importance of structured educational sessions and early peer contact in improving retention in HIV care, especially for racial/ethnic minority communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Support and the HIV Continuum of Care: Results from a Multi-Site Randomized Clinical Trial in Three Urban Clinics in the United States. Cabral, HJ., Davis-Plourde, K., Sarango, M., et al.[2022]

Peer navigation programs for people living with HIV in Victoria, Australia, provide essential social support, helping individuals feel accepted and connected, which can lead to personal change and improved health outcomes.

The study highlights that peer engagement not only helps individuals overcome stigma and access services but also enhances the quality of care by integrating peer insights into clinical practices, suggesting a model that could be replicated in other regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Krulic, T., Brown, G., Graham, S., et al.[2023]

A peer navigation program was piloted in South Africa with 25 newly diagnosed HIV-positive clients, showing high acceptability and satisfaction, which suggests it could effectively enhance engagement in HIV care and ART adherence.

The program addressed significant barriers like HIV stigma by providing education and support, helping clients overcome shame and fears of discrimination, ultimately facilitating better care engagement and prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging HIV-positive clients in care: acceptability and mechanisms of action of a peer navigation program in South Africa. Steward, WT., Sumitani, J., Moran, ME., et al.[2019]

Peer navigation significantly improves the quality of HIV care for female sex workers (FSWs), as evidenced by a study of 211 participants in the Dominican Republic, where 41.2% reported contact with a peer navigator in the last 6 months.

FSWs who engaged with peer navigators experienced more respectful treatment from clinic staff and reported greater satisfaction with their overall HIV care services, highlighting the importance of peer support in enhancing healthcare experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring peer navigation and support in the quality of HIV care experiences of female sex workers in the Dominican Republic. Karver, TS., Barrington, C., Donastorg, Y., et al.[2022]

About 48% of Black and Latinx HIV-negative MSM in western Washington expressed interest in peer navigation for accessing HIV prevention services like PrEP, indicating a significant potential for this strategy.

Factors such as higher sexual stigma increased the acceptability of peer navigation, while higher income and having a regular medical provider decreased it, suggesting that interventions should focus on addressing stigma and targeting lower-income individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's PrEP?: peer navigator acceptability among minority MSM in Washington. Pagkas-Bather, J., Jaramillo, J., Henry, J., et al.[2022]

The program utilizes peer navigators to enhance care for individuals with HIV, providing support and guidance to improve patient outcomes.

This approach highlights the importance of community involvement in healthcare, particularly in resource-limited settings like Kenya, to ensure that patients receive the necessary care and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging peer-based support to facilitate HIV care in Kenya. Karwa, R., Maina, M., Mercer, T., et al.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

A Scoping Review of Peer Navigation Programs for People Living with HIV: Form, Function and Effects. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Development and pilot testing of a standardized training program for a patient-mentoring intervention to increase adherence to outpatient HIV care. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

Engaging HIV-positive clients in care: acceptability and mechanisms of action of a peer navigation program in South Africa. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Exploring peer navigation and support in the quality of HIV care experiences of female sex workers in the Dominican Republic. [2022]

7. England pubmed.ncbi.nlm.nih.gov

What's PrEP?: peer navigator acceptability among minority MSM in Washington. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Leveraging peer-based support to facilitate HIV care in Kenya. [2018]