EMPOWER Strategy for HIV Prevention

(EMPOWER Trial)

Overseen By Allison P Pack, 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 study will address the significant yet often overlooked problem of HIV among cisgender women. To do this, researchers will adapt and test a multilingual technology-based strategy supporting informed decision-making for PrEP in primary care. Specifically, researchers will use the electronic health record to securely send women multimedia educational materials in English or Spanish about PrEP, and facilitate electronic scheduling of PrEP visits - if women decide they are interested. Choice is critical.

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.

How does the EMPOWER Strategy for HIV Prevention differ from other treatments?

The EMPOWER Strategy for HIV Prevention is unique because it focuses on empowering individuals and communities, particularly vulnerable groups, to take control of their health and rights, rather than solely relying on medical interventions. This approach emphasizes social and structural changes, aiming to increase inclusion, agency, and demand for equal rights, which are not typically the focus of standard HIV prevention treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the EMPOWER Strategy treatment 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 improve retention in HIV care. A similar intervention, '60 Minutes for Health', improved retention in care by addressing misinformation, motivation, and coping skills, suggesting that these components can positively impact health behaviors. ^{6 7 8 9 10}

Who Is on the Research Team?

Allison P Pack, 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. England pubmed.ncbi.nlm.nih.gov

60 Minutes for health: examining the feasibility and acceptability of a low-resource behavioral intervention designed to promote retention in HIV care. [2022]

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

Retention in HIV care: what the clinician needs to know. [2022]

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

Improving engagement in HIV care: what can we do? [2008]

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

A qualitative examination of the indirect effects of modified directly observed therapy on health behaviors other than adherence. [2021]

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

Characterizing and improving HIV/AIDS knowledge among cocaine-dependent outpatients. [2007]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The UNAIDS strategy in the prevention of HIV/AIDS in the countries of Eastern Europe]. [2020]

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

Social self-value intervention for empowerment of HIV infected people using antiretroviral treatment: a randomized controlled trial. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Do combination HIV prevention programmes result in increased empowerment, inclusion and agency to demand equal rights for marginalised populations in low-income and middle-income countries? A systematic review. [2022]

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

A prevention response that fits America's epidemic: community perspectives on the status of HIV prevention in the United States. [2020]

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

EVOLUTION--taking charge and growing stronger: the design, acceptability, and feasibility of a secondary prevention empowerment intervention for young women living with HIV. [2021]