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NCT04621760 · ClinicalTrials.gov registry record · NA
The OPENS Trial: Offering Women PrEP (Aim 1)
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 189
- Enrollment target
NCT04621760 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 189 participants.
The verdict
NCT04621760, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 189 participants
- Enrollment target
Study Summary
To address the significant barriers to PrEP implementation for those who were assigned female at birth and self-identify as a woman and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. This study is one part of a multi-component project and involves a patient-level intervention in one public health family planning clinic in Duval County Florida, where the majority of patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed a tablet-based decision support tool that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV. Participants will be randomized to use the HIV decision support tool before their visit or standard counseling (without the use of the tool) and will be surveyed about the use of the tool, experiences with HIV prevention counseling, and intentions about the use of HIV prevention. A subset of participants, all individuals who self-identify as a woman and as Black or Latina, will also complete a post-clinic visit interview. The investigators will follow-up with participants at three months following their initial visit to see if they have initiated the HIV prevention method(s) they chose at their visit. The main outcomes will include a quantitative and qualitative assessment of PrEP or other HIV prevention use, decisional certainty, and satisfaction with information about HIV prevention options. Hypotheses: 1. Women who use the HIV prevention decision support tool will be more likely to have initiated PrEP within 3 months compared to women who received standard counseling at the time of their initial appointment. 2. The HIV prevention decision support tool will increase women's knowledge of PrEP and other HIV prevention methods compared to women who received standard counseling at the t
Interventions
- BEHAVIORAL Standard Counseling
- BEHAVIORAL HIV Prevention Decision Support Tool (DST)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2022-11-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04621760
The ClinicalTrials.gov registry entry for NCT04621760 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 189 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Counseling is the first listed.
NCT04621760 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04621760 about?
NCT04621760 is a clinical study titled "The OPENS Trial: Offering Women PrEP (Aim 1)". To address the significant barriers to PrEP implementation for those who were assigned female at birth and self-identify as a woman and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. This study is one part...
What is the current status of trial NCT04621760?
This trial is currently completed. It is a NA study. The enrollment target is 189 participants. The study started on 2021-05-03. Estimated completion is 2022-11-04.
What interventions are being tested in trial NCT04621760?
The interventions under investigation include: Standard Counseling (BEHAVIORAL), HIV Prevention Decision Support Tool (DST) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04621760?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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