Clinical trial NCT05614492: Development and Evaluation of a PrEP Decision Aid for Women Seeking Domestic Violence Services in Baltimore
Official title: Development and Evaluation of a PrEP Decision Aid for Women Seeking Domestic Violence Services in Baltimore
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: HIV
Violence, Gender-Based
Pre-Exposure Prophylaxis
Keywords: HIV Prevention
Tenofovir
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2022-11-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel: Participants will be assigned to one of three groups in parallel for the duration of the study.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in HIV Risk Perception
timeFrame: Baseline and post intervention, up to 2 minutes
measure: Change in Decisional preference for PrEP
timeFrame: Baseline and post intervention, up to 2 minutes
Secondary outcomes:
measure: Change in PrEP Uptake
timeFrame: Month 1, Month 3, Month 6
Other outcomes:
measure: Change in Feelings of Decisional conflict
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Process Outcomes
timeFrame: Month 6
measure: Urine tenofovir levels
timeFrame: Month 3
measure: Change in Feelings of Decision regret
timeFrame: Baseline, Month 1, Month 3, Month 6
Locations:
city: Baltimore
country: United States
facility: Springboard Community Services - Baltimore City Office
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Tiara Willie, PhD, MA
role: PRINCIPAL_INVESTIGATOR
References: