PrEP Navigation for HIV Prevention

(T'Cher Trial)

Overseen By Erin Meek, DrPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: CrescentCare

Must be taking: PrEP

Disqualifiers: HIV infection, HIV vaccine trial, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators to get a clear answer.

What data supports the effectiveness of the treatment Peer PrEP Navigation for HIV Prevention?

Research shows that PrEP navigation services, which help people access and stick to their HIV prevention medication, can reduce the time it takes for patients to pick up their medication and increase overall PrEP use. These services are effective because they address barriers like lack of health insurance and provide personalized support, making it easier for people to start and continue using PrEP. ^{1 2 3 4 5}

Is PrEP Navigation for HIV Prevention safe for humans?

The research does not provide specific safety data for PrEP Navigation services, but these services are designed to help people take their HIV prevention medication more effectively, which is generally considered safe. ^{1 5 6 7 8}

How is the Peer PrEP Navigation treatment different from other HIV prevention treatments?

Peer PrEP Navigation is unique because it involves trained peers who help individuals access and adhere to HIV prevention services, like PrEP (pre-exposure prophylaxis), by providing education, support, and guidance through the healthcare system. This approach is particularly effective for minority groups who may face barriers to accessing traditional healthcare services. ^{3 5 7 9 10}

What is the purpose of this trial?

The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.

Eligibility Criteria

This trial is for trans women over 18 living in the New Orleans area who want to start or restart PrEP, a medication that prevents HIV. Participants must not be infected with HIV, agree to study procedures, and attend quarterly visits. They cannot join if they're in another PrEP study or have conditions affecting consent or safety.

Inclusion Criteria

I was designated male at birth.

Live in the New Orleans metropolitan statistical area (which includes 8 parishes)

Provision of signed and dated informed consent form

Exclusion Criteria

Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above)

Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity

Concurrent or planned enrollment in a research study that provides PrEP

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive culturally informed health care empowerment and PrEP peer navigation and support through social determinant of health stressors

24 months

Follow-up

Participants are monitored for PrEP uptake and adherence, as well as changes in health care empowerment and social determinant stressors

4 weeks

Treatment Details

Interventions

• Peer PrEP Navigation

Trial Overview The trial tests a Peer PrEP Navigation program aimed at increasing uptake and adherence to PrEP among trans women. It's a single arm stepped wedge design comparing outcomes of participants receiving the intervention immediately versus those with delayed access.

Participant Groups

Group I: PrEP peer navigation Experimental Treatment 1 Intervention

Culturally informed health care empowerment and PrEP peer navigation and support through social determinant of health stressors

Who Is Running the Clinical Trial?

CrescentCare

Lead Sponsor

Trials

1

Recruited

200+

Findings from Research

Nearly half of the participants (47%) who started pre-exposure prophylaxis (PrEP) for HIV prevention discontinued its use, primarily due to systemic issues such as financial problems and logistical barriers related to clinics and pharmacies.

Behavioral factors and concerns about medication side effects also contributed to discontinuation, highlighting the need for addressing both systemic and personal factors to improve PrEP retention and engagement in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. Unger, ZD., Golub, SA., Borges, C., et al.[2023]

The PrIDE project, which ran from 2016 to 2019, successfully implemented a hybrid model of PrEP navigation that combined patient, peer, and systems navigation, leading to effective linking of clients to PrEP and social services across 12 health departments.

Having all PrEP services located in one place significantly boosted PrEP uptake, while challenges such as staff turnover and lack of health insurance were identified, with payment assistance shown to enhance client PrEP use in areas with insurance issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing the future of PrEP navigation: Findings from a five-site cluster evaluation. Salabarría-Peña, Y., Douglas, C., Brantley, M., et al.[2022]

Patient navigation is essential for linking individuals to HIV pre-exposure prophylaxis (PrEP) and re-engaging them in HIV care, as highlighted by a study involving 20 agency staff interviews and 300 patient surveys in Chicago.

Key navigation activities included screening for social determinants of health and providing guidance and referrals, although barriers such as limited staff and clinic capacity were noted, emphasizing the need for adequate resources to support these services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of patient navigation in Chicago: Insights on addressing the social determinants of health and integrating HIV prevention and care services. Greene, GJ., Reidy, E., Felt, D., et al.[2022]

HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV, yet many eligible individuals are not receiving it, highlighting a gap in access to this important preventive measure.

Recommendations from PrEP Coordinators in San Francisco emphasize the need for better training, integration of PrEP into routine care, and proactive strategies to improve patient retention and communication, particularly for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. Shrestha, I., Ming, K., Jimenez, V., et al.[2023]

The implementation of an evidence-based PrEP Navigation tool at a community health center significantly reduced the time from initial prescription to medication pickup by an average of 1.42 days, indicating improved access to PrEP for patients.

This quality improvement project involved 198 patients and highlights the importance of addressing patient-reported barriers to enhance medication adherence and support the uptake of PrEP in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Pharmacy and PrEP Navigation Services to Support PrEP Uptake: A Quality Improvement Project. Coleman, M., Hodges, A., Henn, S., et al.[2020]

In a systematic review of 59 studies involving 43,917 participants, it was found that 41% of individuals discontinued HIV pre-exposure prophylaxis (PrEP) within 6 months, with the highest rates observed in sub-Saharan Africa (47.5%).

Implementing adherence interventions significantly reduced discontinuation rates (24.7% vs 36.7%), and offering flexible dosing options (daily or non-daily) led to lower discontinuation among gay or bisexual men and transgender women (21.6% vs 31.5%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. Zhang, J., Li, C., Xu, J., et al.[2023]

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]

An enhanced adherence support program (enPrEP) for oral PrEP did not significantly improve adherence rates among Black MSM and TGW, with only 30% adherence reported at 12 months.

Factors such as lower education levels and depressive symptoms were associated with lower adherence, highlighting the need for innovative strategies to improve PrEP adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Pre-exposure Prophylaxis in Black Men Who Have Sex with Men and Transgender Women in a Community Setting in Harlem, NY. Colson, PW., Franks, J., Wu, Y., et al.[2022]

Latinx and Black men who have sex with men (MSM) expressed a favorable view of peer navigation services for accessing HIV PrEP, particularly when these services foster connections within their communities.

Barriers to PrEP initiation included concerns about side effects, stigma, and financial issues, highlighting the need for culturally-sensitive programming that matches peers based on shared identities and experiences to enhance PrEP uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Sexual Risk, PrEP Services, and Peer Navigation Support among HIV-Negative Latinx and Black Men who have Sex with Men (MSM) Residing in Western Washington. Jaramillo, J., Pagkas-Bather, J., Waters, K., et al.[2023]

The Project PrIDE initiative in Memphis successfully facilitated HIV PrEP uptake through strategies like client engagement at testing events and building rapport with healthcare staff, which helped improve navigation for clients seeking PrEP.

Challenges included difficulties in assessing client readiness and tracking their progress, as well as stigma experienced by clients, highlighting areas for improvement in future PrEP navigation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'PrEP'ing Memphis: A qualitative process evaluation of peer navigation support. Pichon, LC., Teti, M., Betts, JE., et al.[2023]

References

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

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Informing the future of PrEP navigation: Findings from a five-site cluster evaluation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of patient navigation in Chicago: Insights on addressing the social determinants of health and integrating HIV prevention and care services. [2022]

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

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. [2023]

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

Integrated Pharmacy and PrEP Navigation Services to Support PrEP Uptake: A Quality Improvement Project. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. [2023]

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

Adherence to Pre-exposure Prophylaxis in Black Men Who Have Sex with Men and Transgender Women in a Community Setting in Harlem, NY. [2022]

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

Perceptions of Sexual Risk, PrEP Services, and Peer Navigation Support among HIV-Negative Latinx and Black Men who have Sex with Men (MSM) Residing in Western Washington. [2023]

10. England pubmed.ncbi.nlm.nih.gov

'PrEP'ing Memphis: A qualitative process evaluation of peer navigation support. [2023]