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

NCT ID: NCT05614492

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2025-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Individual Arm (IDM)

Self-administration of the intervention

Group Type: EXPERIMENTAL

Individual PrEP Decision Aid

Intervention Type: 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.

Shared Arm (SDM)

Advocate-administration of the intervention

Group Type: EXPERIMENTAL

Shared PrEP Decision Aid

Intervention Type: 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

Control Arm (Time and Attention Matched Control)

Self-administration of standard PrEP information from Centers for Disease Control (CDC).

Group Type: ACTIVE_COMPARATOR

CDC PrEP Video

Intervention Type: BEHAVIORAL

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

Interventions

Individual PrEP Decision Aid

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.

Intervention Type: BEHAVIORAL

CDC PrEP Video

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

Intervention Type: BEHAVIORAL

Shared PrEP Decision Aid

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

Intervention Type: BEHAVIORAL

Other Intervention Names

IDM; Control; SDM

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiara Willie, PhD, MA

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Springboard Community Services - Baltimore City Office

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R34MH127986-01

Identifier Type: NIH

Identifier Source: org_study_id

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