Development and Evaluation of a PrEP Decision Aid for Women Seeking Domestic Violence Services in Baltimore
- Conditions
- HIVPre-Exposure ProphylaxisViolence, Gender-Based
- Interventions
- Behavioral: CDC PrEP VideoBehavioral: Individual PrEP Decision AidBehavioral: Shared PrEP Decision Aid
- Registration Number
- NCT05614492
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Brief Summary
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.
- Detailed Description
Intimate partner violence (IPV)-exposed Black women are often forced to choose between relationship safety and HIV prevention; thus, trauma-, gender-, culturally-responsive HIV prevention interventions are needed for this key priority population. Pre-exposure prophylaxis (PrEP) may be a viable partner-independent option for IPV-exposed Black women, but no study has identified an evidence-based strategy to promote and increase PrEP uptake among this population, specifically IPV-exposed Black women in the South. Guided by the Consolidated Framework for Implementation Research (CFIR), the proposed research aims to adapt, implement and evaluate self- and advocate-administered versions of a PrEP decision aid in a domestic violence agency in Baltimore in order to increase PrEP uptake among Black women in Ending the HIV Epidemic (EtHE) priority areas, address trauma as a barrier to PrEP uptake, and ultimately combat racial disparities in women's HIV cases.
Therefore, this Type II hybrid effectiveness-implementation study seeks to adapt an existing PrEP decision aid to IPV-exposed Black women seeking domestic violence (DV) services in Baltimore, an EtHE priority state. Self- and advocate-administered versions of the PrEP decision aid will be implemented and the aid will be evaluated using a three-arm randomized trial. The Consolidated Framework for Implementation Research (CFIR) will guide this research. A formative evaluation using qualitative interviews with IPV-exposed Black women (N=10) and DV advocates (N=20) was conducted to adapt the PrEP decision aid. Next, the decision aid will be implemented in a DV agency and 90 IPV-exposed Black women will be randomized to either the self- or advocate-administered versions of the aid, or the control intervention, in order to compare feasibility, acceptability and preliminary effectiveness with baseline, 1-, 3-, and 6-month surveys. Focus groups with DV advocates and participants will assess for implementation process outcomes. This study will: provide support for a PrEP decision aid that addresses HIV prevention for IPV-exposed Black women; use implementation science to increase PrEP uptake; include DV agencies in intervention development and implementation; and improve understanding of PrEP scale-up by addressing implementation factors in settings that serve IPV-exposed Black women.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- age 18 years or older
- self-identification as cisgender female
- IPV-exposed (i.e., at least one physical, sexual, or psychological IPV victimization experience by a male partner) in the past 12 months
- self-reported HIV negative
- English- and/or Spanish-speaking
- self-identify as Black or African American
- Currently using PrEP
- Unable to provide consent
- Participated in formative research for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm (Time and Attention Matched Control) CDC PrEP Video Self-administration of standard PrEP information from Centers for Disease Control (CDC). Individual Arm (IDM) Individual PrEP Decision Aid Self-administration of the intervention Shared Arm (SDM) Shared PrEP Decision Aid Advocate-administration of the intervention
- Primary Outcome Measures
Name Time Method Change in Decisional preference for PrEP Baseline and post intervention, up to 2 minutes Single item screening question: "How interested are you in starting PrEP now?" repeated at the beginning and end of engagement with the decision aid, with responses measured on a 5- point Likert scale, with responders specify their level of agreement to the question in five points: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.
Change in HIV Risk Perception Baseline and post intervention, up to 2 minutes 8-item Perceived Risk of HIV scale repeated at the beginning and end of engagement with the decision aid, with responses measured on a 5- point Likert scale, which has been shown to be more robust than a single-item screening question for HIV risk perception. Specifically, responders will specify their level of agreement to the question in five points: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.
- Secondary Outcome Measures
Name Time Method Change in PrEP Uptake Month 1, Month 3, Month 6 defined as having filled a PrEP prescription (by a composite of self-report and pharmacy refill data) and coded as a binary variable.
Trial Locations
- Locations (1)
Springboard Community Services - Baltimore City Office
🇺🇸Baltimore, Maryland, United States