PrEP Decision Aid for HIV Prevention in Women Facing Domestic Violence
Recruiting in Palo Alto (17 mi)
Overseen byTiara Willie, PhD, MA
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Johns Hopkins Bloomberg School of Public Health
Must not be taking: PrEP
Disqualifiers: Unable to consent, Formative research
No Placebo Group
Prior Safety Data
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.12345
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.36789
How is the PrEP Decision Aid treatment unique for women facing domestic violence?
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.
See 3 more
Exclusion Criteria
I am unable to give my consent.
I am currently taking medication to prevent HIV.
Participated in formative research for this study
Trial 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 (Behavioural Intervention)
- Shared PrEP Decision Aid (Behavioural Intervention)
Trial OverviewThe 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
3Treatment groups
Experimental Treatment
Active Control
Group I: Shared Arm (SDM)Experimental Treatment1 Intervention
Advocate-administration of the intervention
Group II: Individual Arm (IDM)Experimental Treatment1 Intervention
Self-administration of the intervention
Group III: Control Arm (Time and Attention Matched Control)Active Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Springboard Community Services - Baltimore City OfficeBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
Yale UniversityCollaborator
References
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]Pre-exposure prophylaxis (PrEP) is underused in the southern United States (US), a region with high HIV incidence. Clinical decision support (CDS) tools could increase PrEP prescriptions. We explored barriers to PrEP delivery and views of CDS tools to identify refinements for implementation strategies for PrEP prescribing and PrEP CDS tools. We conducted focus groups with health care providers from two federally qualified health centers in Alabama and analyzed the results using rapid qualitative methods. Barriers to PrEP included providers' lack of training in PrEP, competing priorities and time constraints during clinical visits, concerns about side effects, and intensive workload. We identified refinements to the planned implementation strategies to address the barriers, including training all clinic staff in PrEP and having CDS PrEP alerts in electronic health records sent to all staff. Development and deployment of CDS tools in collaboration with providers has potential to increase PrEP prescribing in high-priority jurisdictions.
Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. [2023]HIV pre-exposure prophylaxis (PrEP) has shown high efficacy and effectiveness for HIV prevention; however, many individuals with PrEP indications are not receiving PrEP. PrEP Coordinators work closely with patients and health care providers to increase PrEP access, and they provide unique insights into the inner workings of PrEP care and service delivery. In this study, we discuss key challenges and recommendations for improved PrEP service delivery (including training PrEP Coordinators to manage PrEP panels, making PrEP a part of routine care and optimizing electronic health records, designating a PrEP "champion" who can strengthen communication and leadership, using a proactive approach to increase PrEP retention, and training providers and PrEP Coordinators to meet youth-specific needs) from our discussions with the PrEP Coordinators who led PrEP panel management in San Francisco Department of Public Health primary care clinics.
The Potential of Pre-Exposure Prophylaxis for Women in Violent Relationships. [2022]HIV and intimate partner violence (IPV) are significant intersecting threats to women's health. Women in violent relationships have few feasible HIV risk reduction options as traditional prevention methods are largely dependent on a partner's cooperation. The purpose of this review is to explore potential benefits and drawbacks of pre-exposure prophylaxis (PrEP) use among women in the United States experiencing IPV. Advantages of PrEP use in this population include the potential for covert or autonomous use, coital independence, dual protection against sexual and injection risk, and facilitated connections to social services. A number of barriers, however, may interfere with the effective use of PrEP, including partner resistance, cost, frequent medical visits, gendered norms regarding sexuality, and stigma. To realize its potential for women in violent relationships, it will be necessary to incorporate PrEP into behavioral and structural interventions that encourage uptake, facilitate adherence, ensure women's safety, and challenge existing gender norms.
Decision conflict and the decision support needs of HIV PrEP-eligible Black patients in Toronto regarding the adoption of PrEP for HIV prevention. [2023]Objectives: This study examined factors contributing to decision conflict and the decision support needs of PrEP-eligible Black patients. Methods:The Ottawa Decision Support Framework (ODSF) was used to guide the development of a key informant guide used for qualitative data collection. Black patients assessed by healthcare providers as meeting the basic criteria for starting PrEP were recruited through the St. Michael's Hospital Academic Family Health Team and clinical and community agencies in Toronto. Participants were interviewed by trained research staff. Qualitative content analysis was guided by the ODSF, and analysis was done using the Nvivo. Results: Four women and twenty-five men (both heterosexual and men who have sex with men) were interviewed. Participants reported having difficulty in decision making regarding adoption of PrEP. The main reasons for decision-conflict regading PrEP adoption were: lack of adequate information about PrEP, concerns about the side effects of PrEP, inability to ascertain the benefits or risk of taking PrEP, provider's lack of adequate time for interaction during clinical consultation, and perceived pressure from healthcare provider. Participants identified detailed information about PrEP, and being able to clarify how their personal values align with the benefits and drawbacks of PrEP as their decision support needs. Conclusion:Many PrEP-eligible Black patients who are prescribed PrEP have decision conflict which often causes delay in decision making and sometimes rejection of PrEP. Healthcare providers should offer decision support to Black patients who are being asked to consider PrEP for HIV prevention.
Pathways to HIV Pre-exposure Prophylaxis Among Women Prescribed PrEP at an Urban Sexual Health Clinic. [2020]Little is known about real-world facilitators of and barriers to pre-exposure prophylaxis (PrEP) uptake among women prescribed PrEP. We sought to characterize the pathway to PrEP uptake and continuation in women prescribed PrEP at an urban sexual health-focused clinic. We conducted semi-structured individual interviews with 14 women from October 2016 to May 2017. Using grounded theory and the constant comparative method, we found that self-perceived HIV risk, learning about PrEP through trusted sources, having positive interactions with PrEP providers, and insurance coverage were facilitators of PrEP uptake and continuation. Concerns about PrEP safety, misinformation about PrEP eligibility and appropriateness, lack of insurance coverage, and pharmacy impediments were key barriers. The confluence of these issues led to PrEP rumination, a process of ongoing deliberation about the benefits and risks of PrEP. These findings provide important insights about how to increase PrEP uptake among women at high risk of HIV infection.
Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative Review. [2023]Antiretroviral pre-exposure prophylaxis (PrEP) to prevent HIV transmission was first approved by the US Food and Drug Administration in 2012. Despite correlations of decreases in new HIV infections being greatest where PrEP has been deployed, the uptake of PrEP is lagging, particularly among populations with disproportionate HIV burden. This narrative review seeks to identify individual and systemic barriers to PrEP usage in the USA. A comprehensive search of recent literature uncovered a complex array of structural, social, clinical, and behavioral barriers, including knowledge/awareness of PrEP, perception of HIV risk, stigma from healthcare providers or family/partners/friends, distrust of healthcare providers/systems, access to PrEP, costs of PrEP, and concerns around PrEP side effects/medication interactions. Importantly, these barriers may have different effects on specific populations at risk. The full potential of PrEP for HIV prevention will not be realized until these issues are addressed. Strategies to achieve this goal should include educational interventions, innovative approaches to delivery of HIV care, financial support, and destigmatization of PrEP and PrEP users. Until then, PrEP uptake will continue to be suboptimal, particularly among those who need it most.
Perceived Advantages and Disadvantages of Using Pre-Exposure Prophylaxis (PrEP) among Sexually Active Black Women: An Exploratory Study. [2020]Knowledge of pre-exposure prophylaxis (PrEP) continues to remain scarce among Black women who are disproportionally affected by HIV in the United States. A thematic analysis of open-ended questions from a sample of Black women (n=119) who completed a mix-methods, online, e-health study was conducted to examine the perceived advantages and disadvantages of using PrEP. Being a female controlled method, empowerment, option for women with risky sex partners, and serodiscordant couples were advantages described. Disadvantages of PrEP were identified as the complexity of the choice, encouragement of sex with risky partners, increased burden, promotion of unprotected sex, and newness of the drug.
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]Long-acting injectable (LAI) pre-exposure prophylaxis (PrEP) has the potential to facilitate adherence and transform HIV prevention. However, little LAI PrEP research has occurred among women, who face unique barriers. We conducted 30 in-depth interviews with HIV-negative women from 2017-2018 across six sites (New York; Chicago; San Francisco; Atlanta; Washington, DC; Chapel Hill) of the Women's Interagency HIV Study. Interviews were recorded, transcribed, and analyzed using thematic content analysis. Few women expressed interest in PrEP and when prompted to choose a regimen, 55% would prefer LAI, 10% daily pills, and 33% said they would not take PrEP regardless of formulation. Perceived barriers included: (1) the fear of new-and perceived untested-injectable products and (2) potential side effects (e.g., injection-site pain, nausea). Facilitators included: (1) believing shots were more effective than pills; (2) ease and convenience; and (3) confidentiality. Future studies should incorporate women's LAI PrEP-related experiences to facilitate uptake.
Perspectives of US women participating in a candidate PrEP study: adherence, acceptability and future use intentions. [2023]Limited data exist on acceptability of candidate pre-exposure prophylaxis (PrEP) regimens among US women. We evaluated PrEP experiences, attitudes and future use intentions among sexually active women who completed the US-based HIV Prevention Trials Network 069/AIDS Clinical Trials Group 5305 study.
A Risk Assessment Tool for Identifying Pregnant and Postpartum Women Who May Benefit From Preexposure Prophylaxis. [2019]A human immunodeficiency virus (HIV) risk assessment tool for pregnant women could identify women who would most benefit from preexposure prophylaxis (PrEP) while minimizing unnecessary PrEP exposure.
Understanding PrEP decision making among pregnant women in Lilongwe, Malawi: A mixed-methods study. [2023]Pre-exposure prophylaxis (PrEP) is a promising tool for HIV prevention during pregnancy. With increasing rollout in antenatal settings, counselling strategies to help pregnant women make appropriate decisions about PrEP use are needed. Understanding women's motivations and concerns for PrEP use-and how these inform their decision making and feelings about the decision to start PrEP-are critical to inform these strategies.
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]African adolescent girls and young women (AGYW) have high rates of HIV acquisition and are a priority population for HIV pre-exposure prophylaxis (PrEP). PrEP implementation has been limited by AGYW's low perceived HIV risk and provider demands. A decision support tool (DST) with information about PrEP could improve clients' risk perception, knowledge about PrEP, informed decision-making and motivation to use PrEP based on their risk, facilitating PrEP delivery in primary healthcare (PHC) clinics.
Preference for and Efficacy of a PrEP Decision Aid for Women with Substance Use Disorders. [2022]Women with substance use disorders (SUDs) are a key population for HIV prevention with pre-exposure prophylaxis (PrEP), though uptake is limited by awareness of PrEP, misestimation of personal HIV risk, and minimally integrated HIV prevention and addiction treatment services. Patient-centered decision aids (DA) could address these barriers to PrEP, but no extant DA for PrEP has been published, including for women with SUDs.