PrEP Decision Aid for HIV Prevention in Women Facing Domestic Violence

Overseen By Tiara Willie, Ph.D, MA

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

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)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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 intimate partner violence and are working with a domestic violence service provider. three different ways of delivering the tailored decision aid are being tested: 1) as an individual tool; or 2) as a shared decision-making tool with a domestic violence advocate; as compared to generalized information. The goal of decision aid will be to address key cultural and structural factors affecting these women and can help them gain PrEP awareness 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.

What data supports the effectiveness of the treatment PrEP Decision Aid for HIV Prevention in Women Facing Domestic Violence?

Research shows that decision aids can help people make informed choices about using PrEP (a medication to prevent HIV) by providing detailed information and aligning personal values with the benefits and risks. This approach can be particularly beneficial for women in violent relationships, as it allows for autonomous decision-making and addresses barriers like misinformation and safety concerns. ^{1 2 3 4 5}

Is PrEP generally safe for women, including those facing domestic violence?

PrEP (pre-exposure prophylaxis) has been approved by the US Food and Drug Administration since 2012 for preventing HIV, and while it is generally considered safe, some people have concerns about side effects like nausea and injection-site pain. It's important to discuss any worries with a healthcare provider to understand how PrEP might work for you. ^{3 6 7 8 9}

How is the PrEP Decision Aid treatment unique for women facing domestic violence?

The PrEP Decision Aid is unique because it helps women in violent relationships make informed decisions about using PrEP for HIV prevention without relying on their partner's cooperation, offering a way to protect themselves independently. ^{3 10 11 12 13}

Research Team

Tiara Willie, PhD, MA

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

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

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. [2023]

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

The Potential of Pre-Exposure Prophylaxis for Women in Violent Relationships. [2022]

4. United States 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. [2023]

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

Pathways to HIV Pre-exposure Prophylaxis Among Women Prescribed PrEP at an Urban Sexual Health Clinic. [2020]

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

Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative Review. [2023]

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

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

8. United States 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. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Perspectives of US women participating in a candidate PrEP study: adherence, acceptability and future use intentions. [2023]

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

A Risk Assessment Tool for Identifying Pregnant and Postpartum Women Who May Benefit From Preexposure Prophylaxis. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Understanding PrEP decision making among pregnant women in Lilongwe, Malawi: A mixed-methods study. [2023]

12. Switzerland 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. [2023]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Preference for and Efficacy of a PrEP Decision Aid for Women with Substance Use Disorders. [2022]