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

NCT05614492 | Completed DMC

• 1 other identifier: R34MH127986-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HIV Prevention; Tenofovir

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in PrEP Uptake

  Month 1, Month 3, Month 6

Other Outcomes (4)

• Change in Feelings of Decisional conflict

  Baseline, Month 1, Month 3, Month 6

• Process Outcomes

  Month 6

• Urine tenofovir levels

  Month 3

Study Arms (3)

Individual Arm (IDM)

EXPERIMENTAL

Self-administration of the intervention

Behavioral: Individual PrEP Decision Aid

Shared Arm (SDM)

EXPERIMENTAL

Advocate-administration of the intervention

Behavioral: Shared PrEP Decision Aid

Control Arm (Time and Attention Matched Control)

ACTIVE COMPARATOR

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

Behavioral: CDC PrEP Video

Interventions

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.

Also known as: IDM

Individual Arm (IDM)

CDC PrEP Video BEHAVIORAL

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

Also known as: Control

Control Arm (Time and Attention Matched 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

Also known as: SDM

Shared Arm (SDM)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Currently using PrEP
• Unable to provide consent
• Participated in formative research for this study

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Yale University: collaborator

Study Sites (1)

Springboard Community Services - Baltimore City Office

Baltimore, Maryland, 21209, United States

Location

MeSH Terms

Interventions

SDM

Study Officials

• Tiara Willie, PhD, MA

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel: Participants will be assigned to one of three groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 14, 2022
• Study Start: May 10, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)