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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 1, month 3, month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1, month 3, month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Decisional preference for PrEP
HIV Vaccine
Secondary outcome measures
Change in PrEP Uptake
Other outcome measures
Change in Feelings of Decision regret
Change in Feelings of Decisional conflict
Process Outcomes
+1 moreTrial 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
410 Previous Clinical Trials
2,116,840 Total Patients Enrolled
Yale UniversityOTHER
1,848 Previous Clinical Trials
2,737,728 Total Patients Enrolled
Tiara Willie, PhD, MAPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give my consent.I am currently taking medication to prevent HIV.I am 18 years old or older.I speak English or Spanish.I identify as a cisgender female.I have experienced physical, sexual, or emotional abuse from a male partner in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Individual Arm (IDM)
- Group 2: Shared Arm (SDM)
- Group 3: Control Arm (Time and Attention Matched Control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are there in this experiment?
"Affirmative. On clinicaltrials.gov, the information confirms that this research project is currently looking for participants and was initially posted on May 10th 2023. The study seeks to recruit 90 patients from 1 site before closing its doors."
Answered by AI
Are there open spots for volunteers in this experiment?
"Indeed, the records hosted on clinicaltrials.gov signify that this research project is presently seeking participants. This experiment was first made public on May 10th 2023 and has been updated since then; 90 volunteers are needed from one medical facility."
Answered by AI
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