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?

This trial aims to help Black women in Baltimore start using PrEP, a medication that can prevent HIV. It will explore how a support system, including group and one-on-one sessions with a peer navigator, can facilitate and sustain PrEP initiation. Participants will either join a Peer Navigation Group with regular peer navigator meetings or a control group with just one session. Women who identify as Black, have not taken PrEP before, and have had unprotected sex with at least one male partner in the past six months might be suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to important research that could improve access to HIV prevention methods for Black women.

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 prior data suggests that the Peer Navigation Group is safe for participants?

Research shows that peer navigation is well-received and can help prevent HIV. Studies have found that peer navigators improve HIV care and prevention for many people, including those facing stigma and discrimination. These studies generally reported positive results without major safety concerns. Peer navigation involves trained individuals who guide and support participants. This approach is safe because it does not involve new drugs or medical procedures, making it a low-risk option for those considering joining such a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer Navigation Group for HIV prevention because it offers a more personalized and supportive approach compared to standard methods like medication adherence programs or counseling. This method involves participants engaging in multiple sessions, both in groups and one-on-one, with a peer navigator who has personal experience with HIV prevention. The unique feature here is the peer-led support, which can foster trust and relatability, potentially leading to better engagement and outcomes. This approach could empower individuals in a way traditional treatments might not, by providing direct support from someone who has navigated similar experiences.

What evidence suggests that the Peer Navigation Group is effective for increasing PrEP initiation among Black women?

This trial will compare the effectiveness of peer navigation with a control group for HIV prevention. Studies have shown that peer navigation can significantly enhance HIV prevention and care. Trained individuals with similar experiences assist others in navigating the health care system. Research indicates that peer navigation has maintained low virus levels and improved access to care. Additionally, when combined with pre-exposure prophylaxis (PrEP), peer navigation has effectively boosted HIV prevention efforts. This approach shows promise for supporting groups facing unique challenges, such as intimate partner violence and discrimination, making it a hopeful strategy for increasing PrEP use among Black women. ^{2 3 6 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

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 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]

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]

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]

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]

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5885257/

Effectiveness of a Peer Navigation Intervention to Sustain ...

The LINK LA peer navigation intervention prevented the declines in viral suppression observed in standard care and typically seen after release from ...

2.

prepwatch.org

prepwatch.org/wp-content/uploads/2023/03/Oliveira-et-al-peer-navigators-2023.pdf

the experience of peer navigation in enabling linkage to ...

... peer navigators clas- sify according to research results that conclude that PrEP is highly effective in preventing HIV when four or more ...

3.

joghr.org

joghr.org/article/28347-results-from-a-peer-based-digital-systems-navigation-intervention-to-increase-hiv-prevention-and-care-behaviors-of-young-trans-women-in-rio-de-janeiro

Results from a peer-based digital systems navigation ...

Conclusions. The BeT intervention demonstrated preliminary efficacy for improving HIV prevention and care behaviors among young trans women in a ...

4.

bmchealthservres.biomedcentral.com

bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-07439-4

Exploring peer navigation and support in the quality of HIV ...

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 ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01406626

Effectiveness of Peer Navigation to Link Released HIV+ ...

The intervention is hypothesized to result in greater linkage to care, a greater proportion completing at least three HIV care visits per year, increased self- ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10896188/

Do Peer Navigators Improve Initiation and Retention in HIV ...

Previous randomized controlled trials (RCTs) among general populations have indicated positive effects of peer navigation for HIV/VH/STIs, but these findings ...

7.

hptn.org

hptn.org/sites/default/files/inline-files/15_Lessons%20Learned.pdf

clinical supervision of peer navigators

The expected outcome is that navigators will continue their commitment to work in HIV prevention among Black MSM. Clinical supervision provided for the HPTN 061 ...

8.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT01941108

Technology-Enhanced Peer Navigation to Improve IDUs ...

The role of peer navigators in HIV care is to influence areas which impact engagement in care, namely to: 1) Educate and counsel regarding acceptance of HIV ...