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Completed

NCT Number: NCT05614492

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

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.

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Key information

Conditions

HIV Pre-exposure Prophylaxis Violence, Gender-Based

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Springboard Community Services - Baltimore City Office

Baltimore, Maryland, 21209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individual PrEP Decision Aid

Behavioral

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.

Other names: IDM

CDC PrEP Video

Behavioral

A video from the Centers for Disease Control and Prevention that provides basic, general information on PrEP

Other names: Control

Shared PrEP Decision Aid

Behavioral

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

Other names: SDM

Primary outcomes

  1. Change in HIV Risk Perception

    Time frame: 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.

  2. Change in Decisional preference for PrEP

    Time frame: 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.

Secondary outcomes

  1. Change in PrEP Uptake

    Time frame: 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.

Other outcomes

  1. Change in Feelings of Decisional conflict

    Time frame: Baseline, Month 1, Month 3, Month 6

    Validated measure of decision uncertainty and perceived effective decision making (i.e. about starting PrEP), specifically the healthcare consumers' decision uncertainty, the factors contributing to the uncertainty, and health-care consumers' perceived effective decision making. Utilizes a 5-point Likert scale where responders specify their level of agreement to the questions in five points: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.

  2. Process Outcomes

    Time frame: Month 6

    A qualitative measure of: 1) feasibility of implementing the decision aid; 2) barriers and facilitators to decision aid implementation; 3) experiences conducting the decision aid or perceptions of women's experiences using decision aid; and 4) fidelity to implementation. Data collected through focus group meeting transcripts and analyzed using computer-assisted qualitative data analysis software.

  3. Urine tenofovir levels

    Time frame: Month 3

    As an exploratory measure, urine Tenofovir (TFV) testing will be conducted on a sub-sample of 10 women (randomized to any arm) who start PrEP during the course of the study. Measured with a point of care lateral flow assay test with a sample collected at the Month 3 visit post-randomization to allow women sufficient time to initiate PrEP after receiving the decision aid.

  4. Change in Feelings of Decision regret

    Time frame: Baseline, Month 1, Month 3, Month 6

    5-item validated instrument of personal perceptions after a healthcare decision is made (i.e. starting or not starting PrEP), with responders specify their level of agreement to the questions in five points: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Yale University

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2022
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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