PrEP Awareness Program for HIV Prevention in Black Women

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: PrEP

Disqualifiers: Non-Black, Non-cisgender, others

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

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

Trial Summary

What is the purpose of this trial?

The study objectives are to: * Evaluate implementation outcomes from piloting the Start the Conversation Initiative * Assess initial indicators of clinical effectiveness among patients engaged in the Start the Conversation Initiative These outcomes will be assessed qualitatively through in-depth interviews (IDIs), debriefing sessions with GYN residents and leadership, medical chart reviews and/or de-identified Epic queries, training records, discussions with the Black Women and PrEP (BWAP) Task Force, and social media metrics.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment GYN Residency Training, Social Media Campaign for HIV prevention in Black women?

Social media campaigns have been shown to be a promising tool to increase awareness and uptake of HIV prevention methods like PrEP among young Black and Latinx women, suggesting that similar strategies could be effective in increasing awareness and prevention efforts in Black women. ^{1 2 3 4 5}

Is PrEP safe for use in humans?

The research does not provide specific safety data for PrEP, but it is widely used and considered effective for HIV prevention. Concerns about safety were mentioned by focus group participants, indicating a need for more information and reassurance about its safety. ^{1 2 3 6 7}

How is the drug PrEP unique for HIV prevention in Black women?

PrEP (pre-exposure prophylaxis) is unique because it is a preventive medication taken by HIV-negative individuals to reduce their risk of contracting HIV, and it is highly effective when taken consistently. Unlike other treatments that manage HIV after infection, PrEP is used before exposure to the virus, making it a proactive approach to HIV prevention, especially important for Black women who are disproportionately affected by HIV. ^{2 8 9 10 11}

Research Team

Amy Corneli, MPH, PhD

Principal Investigator

Duke University

Meredith Clement, MD

Principal Investigator

Louisiana State University Health Sciences Center

Eligibility Criteria

This trial is for LSU GYN residents and Black cisgender women who meet the CDC guidelines for PrEP, a medication that helps prevent HIV. It's designed to evaluate an initiative aimed at increasing PrEP use among these women in New Orleans.

Inclusion Criteria

LSU GYN residents

I am a Black cisgender woman eligible for PrEP according to CDC guidelines.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Collection of routine PrEP uptake data to establish a baseline for PrEP prescribing at the GYN residency clinics and local PrEP clinics

4 months

Implementation

Implementation of the combined-care model at the LSU GYN residency clinic at UMCNO and social media campaign in the NOLA area

10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GYN Residency Training
• Social Media Campaign

Trial Overview The 'Start the Conversation' Initiative includes training for GYN residents and a social media campaign, both aiming to boost awareness and uptake of PrEP among eligible Black cisgender women to prevent HIV infection.

Participant Groups

Group I: Start the Conversation Package Experimental Treatment 2 Interventions

The pre-intervention phase will last for 4 months (months 1-4). The only study activity during the pre-intervention phase is the collection of routine PrEP uptake data to establish a baseline for PrEP prescribing at the GYN residency clinics and local PrEP clinics. The implementation of the combined-care model at the LSU GYN residency clinic at UMCNO for 10 months (months 5-14). Then we will add implementation of the social media campaign in the NOLA area for 4 months (months 5-18); implementation of the combined-care model at LSU GYN residency clinic at UMCNO will continue. The layered approach allows for an opportunity to assess the effect of the combined-care model, and subsequently, to what extent the social media campaign additionally engages Black women and builds demand for PrEP.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Only 20.6% of women who use drugs (WWUD) in the U.S. are aware of HIV pre-exposure prophylaxis (PrEP), indicating a significant gap in knowledge about this preventive measure.

Among those who are aware of PrEP, 60.2% expressed willingness to use it, suggesting that increasing awareness could lead to higher uptake of this important HIV prevention strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suboptimal HIV Pre-exposure Prophylaxis Awareness and Willingness to Use Among Women Who Use Drugs in the United States: A Systematic Review and Meta-analysis. Zhang, C., McMahon, J., Simmons, J., et al.[2020]

References

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

Suboptimal HIV Pre-exposure Prophylaxis Awareness and Willingness to Use Among Women Who Use Drugs in the United States: A Systematic Review and Meta-analysis. [2020]

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

Social Media & PrEP: A Systematic Review of Social Media Campaigns to Increase PrEP Awareness & Uptake Among Young Black and Latinx MSM and Women. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Community-Informed Development of a Campaign to Increase HIV Pre-exposure Prophylaxis (PrEP) Awareness Among African-American Young Adults. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Communicative appeals and messaging frames in visual media for HIV pre-exposure prophylaxis promotion to cisgender and transgender women. [2023]

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

Differences in Medical Mistrust Between Black and White Women: Implications for Patient-Provider Communication About PrEP. [2022]

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

Electronic Dissemination of a Web-Based Video Promotes PrEP Contemplation and Conversation Among US Women Engaged in Care at Planned Parenthood. [2022]

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

Pre-exposure prophylaxis prescribing and retention in care among heterosexual women at a community-based comprehensive sexual health clinic. [2022]

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

U.S. Black Women and Human Immunodeficiency Virus Preexposure Prophylaxis Implementation. [2022]

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

Predictors of Pre-exposure Prophylaxis Awareness among African American Young Adults in Louisville, Kentucky. [2022]

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

"Being able to do whatever you wanna do as a woman is important:" a qualitative exploration of contraception as a frame of reference for HIV prevention with PrEP. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Awareness and acceptability of HIV pre-exposure prophylaxis (PrEP) among students at two historically Black universities (HBCU): a cross-sectional survey. [2022]