EMPOWER for PrEP Uptake

(EMPOWER Trial)

Overseen By Mohammad Rifat Haider, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Georgia

Must not be taking: PrEP, PEP

Disqualifiers: Cognitive condition, HIV, others

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

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a group sexual health program called EMPOWER to determine if it increases the use and consistency of PrEP, a medication that prevents HIV. The trial aims to enhance participants' understanding and commitment to regular PrEP use. Two groups participate: one begins the program immediately, while the other joins after a waiting period. Ideal participants are cisgender Black women in Atlanta who engage in risky sexual behaviors and have access to an internet-enabled device for videoconferencing.

As an unphased trial, this study provides a unique opportunity to contribute to important research that could improve sexual health programs and support community well-being.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for increasing PrEP uptake?

Research has shown that PrEP (Pre-Exposure Prophylaxis) is generally safe and easy to tolerate. PrEP, a daily pill, helps prevent HIV. Most people taking PrEP experience few or no side effects, though some might feel mild issues like nausea, which usually subside over time. The EMPOWER program, a group activity, aims to encourage more people to use PrEP. While specific safety data on EMPOWER is unavailable, PrEP's safety is well-established. As EMPOWER is a group activity and not a medication, it likely presents very few safety concerns. Always consult a healthcare provider with questions about joining a study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMPOWER intervention for PrEP uptake because it focuses on improving how people start and continue using PrEP, a medication that helps prevent HIV. Unlike traditional approaches that mainly rely on healthcare providers prescribing and managing PrEP, EMPOWER aims to directly engage individuals, potentially increasing adherence and accessibility. This intervention could empower more people to protect themselves effectively against HIV by making it easier to start and stick with PrEP, which is crucial given the challenges some face in accessing or consistently using the medication.

What evidence suggests that the EMPOWER intervention is effective for increasing PrEP uptake?

Previous studies have shown that EMPOWER increases the use of PrEP, a pill that helps prevent HIV. For example, one study found that 64.2% of participants started using PrEP after joining a similar program, compared to just 27.3% who didn't receive the same support. Another review showed that 82% of the sessions successfully identified people who were using PrEP. In this trial, participants in the Intervention Arm will receive the EMPOWER intervention first, while those in the Waitlist Control will receive it after a wait period. These findings suggest that EMPOWER could effectively help more people start and continue using PrEP. By addressing obstacles to using PrEP, EMPOWER aims to increase both the number of people who begin taking it and those who keep taking it. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for cis-gendered Black women over 18 in Atlanta, GA who've had unprotected sex with non-main or high-risk partners recently. They must have internet access for videoconferencing and plan to stay in the area during the study. It's not for those on PrEP/PEP recently, HIV-positive, or unable to consent.

Inclusion Criteria

Engaging in risky sexual behavior in prior 3 months (condomless vaginal or anal sex with a non-main partner, or a partner with known or suspected risk behavior such as injection drug use or HIV/STI, multiple sex partners, transactional sex)

Access to a device with a screen, a web browser, and adequate internet speed (e.g., smartphone, computer) for videoconferencing

No plans to leave the Atlanta, GA area during the duration of study participation

Exclusion Criteria

I have used PrEP or PEP medication in the last three months.

I am able to understand and agree to the study's procedures and risks.

Unable to speak and read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the EMPOWER intervention, a 6-session group telehealth intervention to improve PrEP uptake and persistence

6 weeks

6 sessions (virtual)

Follow-up

Participants are monitored for PrEP uptake and persistence, as well as intervention feasibility, acceptability, and usability

6 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• EMPOWER

Trial Overview The EMPOWER intervention is being pilot tested to see if it helps increase the use of PrEP among participants. This involves a group sexual health program aimed at empowering African American women to make informed decisions about HIV prevention.

How Is the Trial Designed?

Group I: Intervention Arm Active Control 1 Intervention

This arm will receive the intervention first.

Group II: Waitlist Control Active Control 1 Intervention

This arm will receve the intervention after the wait period

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10191268/

Protocol for a stepped-wedge cluster randomized trial (SW-CRT) POWER Up is an evidence-based, woman-focused set of five implementation science strategies that addresses barriers of PrEP utilization.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10927298/

Effectiveness of PrEPTECH: Findings From a 180-Day ... On completion of the 90-day postbaseline survey, 64.2% of those in the PrEPTECH arm had taken PrEP since study start versus 27.3% of those in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0749379721003585

Pre-exposure Prophylaxis Uptake, Adherence, and ... A review of 1,000 case report forms that contained any iNSC information from 178 participants indicated that 82% of sessions successfully identified PrEP use ...

4. researchprotocols.org researchprotocols.org/2023/1/e42844

Effectiveness of a Community Empowerment Intervention ... The key outcomes of phase 1 will be the analysis of the verbatim responses of MWSWs and institutional actors about the determinants of PrEP use, ...

5. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(23)00252-2/fulltext

Optimal strategies to improve uptake of and adherence ... Visually, we observed increased PrEP use for all groups from baseline to month 4, then decreasing for all groups except for the combined intervention group ...

6. withpower.com withpower.com/trial/phase-hiv-pre-exposure-prophylaxis-7-2026-a1f24

EMPOWER for PrEP Uptake · Info for Participants The EMPOWER medical study, being run by University of Georgia, needs participants to evaluate whether EMPOWER will have tolerable side effects & efficacy ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03652623

Transgender Youth and PrEP: PK, Safety, Uptake & ... To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth ...

8. trial.medpath.com trial.medpath.com/clinical-trial/567738daad20a067/nct07173816-prep-uptake-african-american-women-hiv-prevention

Optimizing PrEP Uptake for African American Women in the ... Pilot testing of EMPOWER, a group sexual health intervention, to increase uptake and persistence of PrEP.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5954995/

U.S. Guidelines that empower women to prevent HIV with ... PrEP, a daily pill that prevents HIV, can empower women with a method of HIV prevention that they can control and do not need to negotiate with male partners.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04077151

Transgender Youth and PrEP: PK, Safety, Uptake & ... To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth ...