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Behavioural Intervention

PrEP Decision Aid for HIV Prevention in Women Facing Domestic Violence

Phase 2 & 3
Recruiting
Led By Tiara Willie, PhD, MA
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1, month 3, month 6
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a decision aid tailored to Black women with intimate partner violence who work with a domestic violence service provider, to help them access PrEP.

Who is the study for?
This trial is for Black or African American cisgender women over 18 who have experienced intimate partner violence in the past year, are HIV negative, and speak English or Spanish. It's not for those already using PrEP, unable to consent, or who were part of this study's early research.
What is being tested?
The study tests a PrEP decision aid designed specifically for these women. It compares three methods: an individual tool, a shared tool with a domestic violence advocate, and general information from the CDC about PrEP.
What are the potential side effects?
Since this trial focuses on decision aids rather than medication, there are no direct medical side effects. However, participants may experience emotional discomfort discussing sensitive topics like intimate partner violence.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1, month 3, month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1, month 3, month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Decisional preference for PrEP
HIV Vaccine
Secondary study objectives
Change in PrEP Uptake
Other study objectives
Change in Feelings of Decision regret
Change in Feelings of Decisional conflict
Process Outcomes
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Shared Arm (SDM)Experimental Treatment1 Intervention
Advocate-administration of the intervention
Group II: Individual Arm (IDM)Experimental Treatment1 Intervention
Self-administration of the intervention
Group III: Control Arm (Time and Attention Matched Control)Active Control1 Intervention
Self-administration of standard PrEP information from Centers for Disease Control (CDC).

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
431 Previous Clinical Trials
2,135,106 Total Patients Enrolled
Yale UniversityOTHER
1,930 Previous Clinical Trials
3,033,368 Total Patients Enrolled
Tiara Willie, PhD, MAPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health

Media Library

Individual PrEP Decision Aid (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05614492 — Phase 2 & 3
Gender-Based Violence Research Study Groups: Individual Arm (IDM), Shared Arm (SDM), Control Arm (Time and Attention Matched Control)
Gender-Based Violence Clinical Trial 2023: Individual PrEP Decision Aid Highlights & Side Effects. Trial Name: NCT05614492 — Phase 2 & 3
Individual PrEP Decision Aid (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05614492 — Phase 2 & 3
~24 spots leftby Jul 2025
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