PrEP Decision Aid for HIV Prevention in Women Facing Domestic Violence

Overseen By Tiara Willie, Ph.D, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Must not be taking: PrEP

Disqualifiers: Unable to consent, Formative research

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Black women who have faced intimate partner violence better understand and access PrEP, a medication that can prevent HIV. The study tests three methods of delivering information about PrEP: an Individual PrEP Decision Aid (a tool for personal use), a Shared PrEP Decision Aid (a tool used with a domestic violence advocate), and standard information. It examines cultural and structural factors that may affect these women. Women who have experienced physical, sexual, or psychological violence from a male partner in the past year and are HIV-negative might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to important research that could improve access to HIV prevention for Black women.

Will I have to stop taking my current medications?

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

What prior data suggests that this decision aid is safe for use in women facing domestic violence?

Research has shown that the PrEP (pre-exposure prophylaxis) decision aid has been carefully developed and tested for women at risk of HIV. These studies focused on women dealing with substance use issues and those experiencing intimate partner violence (IPV). The results suggest that the decision aid is easy to use and effectively reaches women who need HIV prevention the most.

No specific side effects or problems have been reported from using the decision aid itself. It is important to note that PrEP, the medication discussed in the decision aid, has already received FDA approval for preventing HIV, indicating its general safety. The decision aid assists women in understanding and deciding if PrEP is right for them, without introducing any new medical risks.

In summary, the decision aid serves as a helpful tool with no known safety concerns, and PrEP remains a well-established option for prevention. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different decision aids can empower women facing domestic violence to make informed choices about HIV prevention using PrEP (pre-exposure prophylaxis). Unlike standard information dissemination methods, this trial examines two unique approaches: an Individual PrEP Decision Aid, which women can use on their own, and a Shared PrEP Decision Aid, facilitated by an advocate. These aids are designed to provide personalized support and guidance, potentially making it easier for women to understand and decide on using PrEP effectively in challenging circumstances. By tailoring the decision-making process, researchers hope to find out which method better supports women in high-risk situations, potentially leading to improved health outcomes.

What evidence suggests that this trial's decision aids could be effective for HIV prevention in women facing domestic violence?

Research has shown that pre-exposure prophylaxis (PrEP) effectively prevents HIV infection. This trial will evaluate different approaches to using a PrEP decision aid designed for women experiencing intimate partner violence (IPV). Participants in the Individual Arm will self-administer the PrEP Decision Aid, while those in the Shared Arm will receive the aid through advocate-administration. Studies have found that including a PrEP decision aid in domestic violence services can reach women at high risk for HIV. This approach supports women in making informed choices about using PrEP to protect themselves. Early findings suggest that both individual and shared decision aids improve understanding and use of PrEP among women facing IPV. ^{1 2 3 6 7}

Who Is on the Research Team?

Tiara Willie, PhD, MA

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for Black or African American cisgender women over 18 who have experienced intimate partner violence in the past year, are HIV negative, and speak English or Spanish. It's not for those already using PrEP, unable to consent, or who were part of this study's early research.

Inclusion Criteria

Self-identify as Black or African American

Self-reported HIV negative

I identify as a cisgender female.

Exclusion Criteria

I am unable to give my consent.

I am currently taking medication to prevent HIV.

Participated in formative research for this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Participants receive the PrEP decision aid, either self-administered or advocate-administered, and are randomized into different arms

6 months

Baseline, Month 1, Month 3, Month 6

Follow-up

Participants are monitored for changes in decisional conflict, decision regret, and PrEP uptake

6 months

Baseline, Month 1, Month 3, Month 6

Evaluation

Focus groups and qualitative interviews are conducted to assess implementation process outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Individual PrEP Decision Aid
• Shared PrEP Decision Aid

Trial Overview

The study tests a PrEP decision aid designed specifically for these women. It compares three methods: an individual tool, a shared tool with a domestic violence advocate, and general information from the CDC about PrEP.

How Is the Trial Designed?

Group I: Shared Arm (SDM) Experimental Treatment 1 Intervention

Advocate-administration of the intervention

Group II: Individual Arm (IDM) Experimental Treatment 1 Intervention

Self-administration of the intervention

Group III: Control Arm (Time and Attention Matched Control) Active Control 1 Intervention

Self-administration of standard PrEP information from Centers for Disease Control (CDC).

Individual PrEP Decision Aid is already approved in United States, European Union, Canada for the following indications:

Approved in United States as PrEP for:

• HIV prevention

Approved in European Union as PrEP for:

• HIV prevention

Approved in Canada as PrEP for:

• HIV prevention

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

Pregnant women in Malawi showed strong motivation to use PrEP for HIV protection for themselves and their unborn child, despite concerns about safety, side effects, and stigma, indicating a high level of acceptance of PrEP during pregnancy.

Most women felt positively about their decision to start PrEP, but those with more concerns, particularly about partner disclosure and pill attributes, experienced greater decisional regret, suggesting the need for supportive counseling strategies that address these concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding PrEP decision making among pregnant women in Lilongwe, Malawi: A mixed-methods study. Hill, LM., Golin, CE., Saidi, F., et al.[2023]

Despite the effectiveness of antiretroviral pre-exposure prophylaxis (PrEP) in reducing new HIV infections since its approval in 2012, uptake remains low, especially among high-risk populations due to various barriers.

Key barriers to PrEP usage include lack of awareness, stigma, distrust in healthcare, access issues, and concerns about side effects, highlighting the need for targeted educational and support strategies to improve PrEP adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative Review. Mayer, KH., Agwu, A., Malebranche, D.[2023]

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]

Healthcare providers in Alabama identified several barriers to prescribing PrEP, including insufficient training, time constraints, and concerns about side effects, which contribute to its underuse in a high HIV incidence area.

Implementing clinical decision support (CDS) tools, along with comprehensive training for all clinic staff, could enhance PrEP prescribing practices and address these barriers effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Health Care Professionals' Perspectives to Refine a Clinical Decision Support Implementation Strategy for Increasing the Prescribing of HIV Preexposure Prophylaxis (PrEP) in Alabama. Humphries, DL., Rhodes, EC., Simon, CL., et al.[2023]

The patient-centered decision aid (DA) for PrEP significantly increased interest in PrEP among women in addiction treatment, with interest rising from 25% to 89% for those who chose to use the DA.

Women using the DA were more likely to see a healthcare provider for PrEP compared to those receiving enhanced standard of care, indicating that the DA effectively engaged participants in the HIV prevention process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preference for and Efficacy of a PrEP Decision Aid for Women with Substance Use Disorders. Meyer, J., Price, C., Tracey, D., et al.[2022]

A study involving 119 Black women revealed that many perceive PrEP as empowering, especially as a female-controlled method that can help protect against HIV, particularly for those with risky partners or in serodiscordant relationships.

However, concerns were raised about the complexities of using PrEP, including the potential to encourage risky sexual behavior and the burden of managing a new medication, highlighting the need for better education and support around its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Advantages and Disadvantages of Using Pre-Exposure Prophylaxis (PrEP) among Sexually Active Black Women: An Exploratory Study. Bond, KT., Gunn, AJ.[2020]

A study involving 130 women showed that while most reported good adherence to PrEP, some admitted to over-reporting, indicating a need for better adherence support and education.

Many women expressed intentions not to use PrEP in the future due to perceived low personal risk and concerns about affordability, rather than side effects, highlighting the importance of addressing these barriers to improve PrEP uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of US women participating in a candidate PrEP study: adherence, acceptability and future use intentions. Amico, KR., Ramirez, C., Caplan, MR., et al.[2023]

Pre-exposure prophylaxis (PrEP) offers significant advantages for women experiencing intimate partner violence (IPV), such as the ability for covert use and dual protection against both HIV and injection risks, which can empower women in unsafe relationships.

However, barriers like partner resistance, cost, and societal stigma may hinder PrEP's effectiveness, highlighting the need for integrated interventions that promote safe use and challenge harmful gender norms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of Pre-Exposure Prophylaxis for Women in Violent Relationships. Braksmajer, A., Senn, TE., McMahon, J.[2022]

A study involving 29 Black patients (4 women and 25 men) revealed that many experienced decision conflict regarding the adoption of PrEP due to insufficient information, concerns about side effects, and inadequate time during consultations with healthcare providers.

Participants expressed a need for more detailed information about PrEP and support in aligning their personal values with the treatment's benefits and risks, highlighting the importance of decision support in improving PrEP uptake among eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision conflict and the decision support needs of HIV PrEP-eligible Black patients in Toronto regarding the adoption of PrEP for HIV prevention. Ajiboye, W., Nelson, L., Odhiambo, A., et al.[2023]

A new HIV risk assessment tool for pregnant women was developed using data from 654 participants, which effectively predicts the risk of HIV acquisition based on factors like partner's HIV status and history of infections, achieving a high predictive accuracy (AUC of 0.84).

The tool can help prioritize women for preexposure prophylaxis (PrEP), as those with higher risk scores (over 6) accounted for a significant portion (56%) of HIV acquisitions, despite only representing 16% of the population studied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Risk Assessment Tool for Identifying Pregnant and Postpartum Women Who May Benefit From Preexposure Prophylaxis. Pintye, J., Drake, AL., Kinuthia, J., et al.[2019]

The MyPrEP decision support tool significantly improved PrEP persistence among African adolescent girls and young women, with 19% of users continuing PrEP at 1 month compared to 10% in the control group, indicating its potential to enhance long-term adherence.

PrEP initiation rates were high in both groups (97% for MyPrEP and 94% for control), suggesting that the tool effectively supports young women in starting PrEP, while 99% of users reported satisfaction with the MyPrEP tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decision support tool has similar high PrEP uptake and increases early PrEP persistence in adolescent girls and young women in South Africa: results from a randomized controlled trial. Celum, C., Seidman, D., Travill, D., et al.[2023]

A study involving 30 in-depth interviews with HIV-negative women revealed that while 55% preferred long-acting injectable (LAI) PrEP over daily pills, overall interest in PrEP was low, with 33% unwilling to take any form of PrEP.

Barriers to LAI PrEP included fears about the safety and side effects of injections, while perceived benefits included the belief that injections might be more effective and the convenience of not having to take daily pills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest in Long-Acting Injectable Pre-exposure Prophylaxis (LAI PrEP) Among Women in the Women's Interagency HIV Study (WIHS): A Qualitative Study Across Six Cities in the United States. Philbin, MM., Parish, C., Kinnard, EN., et al.[2022]

Facilitators for women to start and continue using PrEP included a strong awareness of their own HIV risk, positive experiences with healthcare providers, and having insurance coverage, as identified through interviews with 14 women at a sexual health clinic.

Barriers to PrEP uptake included concerns about safety, misinformation regarding eligibility, lack of insurance, and difficulties at pharmacies, which led to a state of 'PrEP rumination' where women continuously weighed the pros and cons of using the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways to HIV Pre-exposure Prophylaxis Among Women Prescribed PrEP at an Urban Sexual Health Clinic. Park, CJ., Taylor, TN., Gutierrez, NR., et al.[2020]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05614492

Development and Evaluation of a PrEP Decision Aid ...

This study is designed to develop and test an individual decision aid for pre-exposure prophylaxis (PrEP) tailored to Black women who have been exposed to ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11407614/

A PrEP decision aid for women survivors of intimate partner ...

A recently developed PrEP decision aid for women has the potential to reach IPV survivors at risk for HIV if it could be integrated into existing domestic ...

3.

medicine.yale.edu

medicine.yale.edu/lab/jmeyer/research/

Research and Projects < J. Meyer Lab - Yale School of Medicine

This Type II hybrid effectiveness-implementation study seeks to adapt an existing PrEP decision aid to intimate partner violence (IPV)-exposed women seeking ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8420782/

Preference for and Efficacy of a PrEP Decision Aid for Women ...

Why was this study done? Women with substance use disorders are at high risk for HIV and could benefit from pre-exposure prophylaxis (PrEP) for ...

5.

medrxiv.org

medrxiv.org/content/10.1101/2023.09.12.23295455v1.full.pdf

Task-Shifting Implementation to Domestic Violence Service

In contrast, HIV pre-exposure prophylaxis (PrEP) is a user-controlled, event- independent intervention that effectively prevents HIV and is an ...

6.

reporter.nih.gov

reporter.nih.gov/project-details/10654773

Project Details - NIH RePORTER

This study will: provide support for a PrEP decision aid that addresses HIV prevention for the key population of IPV-exposed Black women; use implementation ...

7.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/414675

Development and Evaluation of a PrEP Decision Aid ...

This study is designed to develop and test an individual decision aid for pre-exposure prophylaxis (PrEP) tailored to Black women who have ...