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PrEP Outreach Strategies for Reducing HIV Risk
N/A
Recruiting
Led By Akilah Pope, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-identify as a woman (regardless of pregnancy status)
Age 18 years - 45 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post baseline visit
Awards & highlights
Study Summary
This trial will assess a new approach to helping women of color reduce their risk of HIV in a high-risk area of the US. It involves a decision-making tool and improved clinic training.
Who is the study for?
The OPENS Trial is for English-speaking women aged 18-45 who are not currently living with HIV, based on self-report. It's aimed at those interested in participating and willing to be contacted after 3 months. Women already using PrEP or unable to consent are excluded, as well as individuals assigned male at birth who identify as a man.Check my eligibility
What is being tested?
This trial tests two interventions: clinic-wide trainings and a tablet-based HIV Prevention Decision Support Tool (DST). The study evaluates how these methods affect patients' decisions regarding HIV prevention strategies in a high-incidence area of Florida.See study design
What are the potential side effects?
Since the interventions involve educational tools and training rather than medications, there are no direct medical side effects. However, participants may experience emotional or psychological impacts from discussing sensitive topics like HIV prevention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I identify as a woman.
Select...
I am between 18 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post baseline visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post baseline visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PrEP Prescriptions (As Measured by Chart Review)
Secondary outcome measures
Acceptability of HIV Prevention Methods
Acceptability of the Decision Support Tool
HIV
+22 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST)Experimental Treatment1 Intervention
Participants in this arm will receive care in a clinic where providers and staff have been trained in shared decision making and trauma informed care, and receive the HIV prevention DST intervention immediately before their provider visit.
Group II: Care Post Clinic-Wide TrainingsActive Control1 Intervention
Participants in this arm will receive care in a clinic where providers and staff have been trained in shared decision making and trauma-informed care. Participants in this arm will not view the decision support tool in this phase.
Group III: Standard Care without the HIV Prevention Decision Support Tool (DST)Active Control1 Intervention
Participants in this arm will receive usual care at a clinic that has not received training in shared decision making and trauma-informed care. These participants also will not have viewed the HIV prevention DST. These participants were recruited in Aim 1 of this study.
Group IV: Standard care with the HIV Prevention Decision Support Tool (DST)Active Control1 Intervention
Participants in this arm will receive usual care at a clinic that has not received training in shared decision making and trauma-informed care. These participants will view the HIV prevention DST. These participants were recruited in Aim 1 of this study.
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,496 Previous Clinical Trials
11,934,323 Total Patients Enrolled
Florida Department of HealthOTHER_GOV
28 Previous Clinical Trials
12,677 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
376 Previous Clinical Trials
1,214,790 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 45 years old.I am not willing to be contacted in 3 months.I identify as a woman.I was assigned male at birth and identify as a man.I am currently taking medication to prevent HIV.I am interested in joining the study.I am unable to give consent by myself.
Research Study Groups:
This trial has the following groups:- Group 1: Care Post Clinic-Wide Trainings
- Group 2: Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST)
- Group 3: Standard Care without the HIV Prevention Decision Support Tool (DST)
- Group 4: Standard care with the HIV Prevention Decision Support Tool (DST)
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.
Is the upper age limit for this clinical trial adjustable to encompass octogenarians?
"The requirements for taking part in this trial dictate a minimum age of 18 and upper limit of 45."
Answered by AI
Is this experimental research currently accepting new participants?
"The data hosted on clinicaltrials.gov evidences that this particular trial, initially posted on November 9th 2022, is not presently recruiting participants. Despite this fact, 716 other studies are actively seeking patients at the present time."
Answered by AI
Who would be most beneficial to recruit for this trial?
"This clinical trial is accepting 366 participants with sexually transmitted diseases, who are within the ages of 18 and 45."
Answered by AI
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