Development and Evaluation of a PrEP Decision Aid for Women Seeking Domestic Violence Services in Baltimore

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Evaluation of a PrEP Decision Aid for Women Seeking Domestic Violence Services in Baltimore

Conditions
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HIV, Violence, Gender-Based, Pre-Exposure Prophylaxis

Intervention / Treatment
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* Behavioral: Individual PrEP Decision Aid
* Behavioral: CDC PrEP Video
* Behavioral: Shared PrEP Decision Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Currently using PrEP Unable to provide consent Participated in formative research for this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel: Participants will be assigned to one of three groups in parallel for the duration of the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual Arm (IDM)<br>Self-administration of the intervention | Behavioral: Individual PrEP Decision Aid<br>* Participant engages with the decision support tool designed to optimize PrEP uptake among Black cisgender women who have experienced IPV independently. They also enter data independently.<br>* Other names: IDM;|
| Experimental: Shared Arm (SDM)<br>Advocate-administration of the intervention | Behavioral: Shared PrEP Decision Aid<br>* Domestic violence service advocate (DVA) engages with the decision support tool designed to optimize PrEP uptake among Black cisgender women who have experienced IPV with the participant and enters data<br>* Other names: SDM;|
| Active Comparator: Control Arm (Time and Attention Matched Control)<br>Self-administration of standard PrEP information from CDC. | Behavioral: CDC PrEP Video<br>* A video from the Centers for Disease Control and Prevention that provides basic, general information on PrEP<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV Risk Perception | 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. | Baseline and post intervention, up to 2 minutes | 
| Change in Decisional preference for PrEP | 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. | Baseline and post intervention, up to 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PrEP Uptake | defined as having filled a PrEP prescription (by a composite of self-report and pharmacy refill data) and coded as a binary variable. | Month 1, Month 3, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Prevention, Tenofovir