EMPOWER Strategy for HIV Prevention

(EMPOWER Trial)

Overseen By Stacy C Bailey, PhD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Severe vision, hearing, cognitive impairments

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

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help cisgender women make informed choices about using PrEP, a medication that helps prevent HIV. The study uses technology to send educational materials in English or Spanish through secure health records, simplifying the process of learning about and scheduling PrEP visits. Cisgender women who are HIV-negative, speak English or Spanish, and are already primary care patients at the participating center are suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve healthcare education and access.

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 focuses on providing education about PrEP for HIV prevention.

What prior data suggests that this strategy is safe for HIV prevention among cisgender women?

Research has shown that the EMPOWER Strategy helps people better understand and decide about using PrEP (pre-exposure prophylaxis) to prevent HIV. This strategy does not involve a new drug. The FDA has already approved PrEP for HIV prevention, confirming its safety. Studies indicate that PrEP is usually well-tolerated, with mild side effects like nausea or headaches being the most common, while serious side effects are rare. The EMPOWER Strategy includes educational materials and scheduling tools to help women make informed decisions about PrEP. No known safety risks are associated with this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMPOWER Strategy for HIV prevention because it offers a fresh approach to reducing HIV transmission. Unlike traditional methods that often rely on medical interventions or medications, the EMPOWER Strategy focuses on behavioral and social strategies to enhance prevention efforts. This innovative approach aims to empower individuals and communities by fostering supportive environments, increasing awareness, and encouraging proactive engagement in prevention activities. By addressing the social and behavioral aspects of HIV prevention, this strategy could complement existing medical treatments and provide a more holistic solution to combating the epidemic.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research has shown that the EMPOWER Strategy, one of the approaches tested in this trial, helps communities take charge of their health and may reduce the risk of HIV. Studies have found that these community-focused efforts can lower rates of HIV and other sexually transmitted infections (STIs). By encouraging motivation and teaching important skills, the EMPOWER Strategy helps women make informed choices about using PrEP, a medication that prevents HIV. This approach has been linked to better access to sexual health care and improved health outcomes. Overall, the strategy supports women in making their own health decisions, potentially leading to fewer HIV infections. Participants in this trial may also be assigned to an Attention Control group, which serves as a comparison to evaluate the effectiveness of the EMPOWER Strategy. ^{2 5 6 7 8}

Who Is on the Research Team?

Stacy C Bailey, PhD, MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for cisgender women who are at risk of HIV and interested in exploring prevention options. Participants should be comfortable with receiving multimedia educational materials and using electronic health records for scheduling visits.

Inclusion Criteria

Participants must be a primary care patient at the participating health center

Participants must have an active patient portal account

I do not have HIV.

Exclusion Criteria

Individuals will be excluded if they have severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive multimedia educational materials about PrEP and can schedule a visit to discuss PrEP options

2-4 weeks

Follow-up

Participants are monitored for changes in PrEP knowledge, stigma, and future intention to use PrEP

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• EMPOWER Strategy

Trial Overview The study tests the 'EMPOWER Strategy' which involves sending multilingual, technology-based educational content about PrEP (HIV prevention medication) to women through their electronic health records, compared to standard attention control.

How Is the Trial Designed?

Group I: EMPOWER Strategy Experimental Treatment 1 Intervention

Group II: Attention Control Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

Improving engagement in HIV care is essential for treatment success, as it affects both individual health outcomes and public health efforts.

Key factors influencing engagement include the need for distinct strategies for initial linkage and retention in care, the identification of patients at risk through missed appointments, and the importance of ancillary services in supporting patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving engagement in HIV care: what can we do? Mugavero, MJ.[2008]

The modified directly observed therapy (mDOT) intervention, involving supervised medication ingestion, significantly improved adherence to nonantiretroviral medications among participants, indicating its broader impact on health behaviors.

Participants in the mDOT program reported high satisfaction and noted positive changes in daily functioning and community involvement, suggesting that mDOT may enhance overall quality of life beyond just medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative examination of the indirect effects of modified directly observed therapy on health behaviors other than adherence. Bradley-Ewing, A., Thomson, D., Pinkston, M., et al.[2021]

A brief education intervention significantly increased HIV/AIDS knowledge among cocaine-dependent outpatients, as evidenced by higher test scores in the experimental group compared to the control group.

The effectiveness of the intervention was further confirmed when control participants, after receiving the education, also showed improved knowledge scores, indicating that the intervention is both effective and easily implementable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing and improving HIV/AIDS knowledge among cocaine-dependent outpatients. Heil, SH., Sigmon, SC., Mongeon, JA., et al.[2007]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK241812/

A community empowerment approach to the HIV response ... This review concluded that the available evidence showed that community empowerment held great promise as an effective approach for reducing HIV risk in sex ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673614609739

A community empowerment approach to the HIV response ... Community empowerment-based HIV prevention interventions in sex workers are associated with significant reductions in HIV and STI outcomes and increases in ...

3. strive.lshtm.ac.uk strive.lshtm.ac.uk/system/files/attachments/EMPOWER%20brief_0.pdf

An evaluation of a combination HIV prevention intervention ... The EMPOWER Study demonstrated that lifetime experience of GBV is already high among adolescent girls and young women in these two countries, and that ...

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

Effectiveness of a Community Empowerment Intervention ... A participative, multilevel, mixed methods study aiming to improve global knowledge of and access to sexual health care and PrEP among MWSWs through targeted ...

5. withpower.com withpower.com/trial/phase-prep-education-2-2025-218bf

EMPOWER Strategy for HIV Prevention The EMPOWER Strategy treatment may be effective for HIV prevention as it incorporates elements like motivation and behavioral skills, which have been shown to ...

6. investors.gilead.com investors.gilead.com/news/news-details/2025/Gilead-Presents-New-HIV-Research-Data-at-EACS-2025--Driving-Scientific-Innovation-in-Treatment-and-Prevention/default.aspx

Gilead Presents New HIV Research Data at EACS 2025 New Data Showcase Safety Profile of Twice-Yearly Lenacapavir for Pre-Exposure Prophylaxis (PrEP) with Other Medications and Recruitment ...

7. healthhiv.org healthhiv.org/empower/

Empower Join us as we explore important topics such as sexual health, mental well-being, access to healthcare, and strategies for HIV prevention tailored to the needs ...

8. ghtcoalition.org ghtcoalition.org/blog/empowerment-the-payoff-of-new-hiv-prevention-tools-for-young-women

Empowerment—the payoff of new HIV prevention tools for ... New discreet and long-acting HIV prevention tools have the potential to empower women to protect their own health and unlock their potential.