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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 below
Select...
I identify as a woman.
Select...
I am between 18 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post baseline visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post baseline visit for reporting.

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 more

Trial 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

Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST) Clinical Trial Eligibility Overview. Trial Name: NCT05619497 — N/A
HIV/AIDS Research Study Groups: Care Post Clinic-Wide Trainings, Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST), Standard Care without the HIV Prevention Decision Support Tool (DST), Standard care with the HIV Prevention Decision Support Tool (DST)
HIV/AIDS Clinical Trial 2023: Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST) Highlights & Side Effects. Trial Name: NCT05619497 — N/A
Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05619497 — N/A

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
~43 spots leftby May 2024