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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614492
• Other study ID #: R34MH127986-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 10, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: January 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Tiara Willie, Ph.D, MA
• Phone: 410-614-2686
• Email: twillie2[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• CDC PrEP Video
A video from the Centers for Disease Control and Prevention that provides basic, general information on PrEP
• 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

Locations

Country	Name	City	State
United States	Springboard Community Services - Baltimore City Office	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Feelings of Decisional conflict	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.	Baseline, Month 1, Month 3, Month 6
Other	Process Outcomes	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.	Month 6
Other	Urine tenofovir levels	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.	Month 3
Other	Change in Feelings of Decision regret	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.	Baseline, Month 1, Month 3, Month 6
Primary	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
Primary	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	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