The OPENS Trial: Offering Women PrEP (Aim 1)
Public ClinicalTrials.gov record NCT04621760. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Offering Women PrEP With Education and Shared Decision-making
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 time of their initial appointment. 3. The HIV prevention decision support tool will increase participants' decisional certainty in their choice of an HIV prevention method compared to women who received standard counseling at the time of their initial appointment.
Study identification
- NCT ID
- NCT04621760
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 189 participants
Conditions and interventions
Interventions
- HIV Prevention Decision Support Tool (DST) Behavioral
- Standard Counseling Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2, 2021
- Primary completion
- Oct 23, 2022
- Completion
- Nov 3, 2022
- Last update posted
- Jul 30, 2026
2021 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida Department of Health in Duval County | Jacksonville | Florida | 32211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04621760, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04621760 live on ClinicalTrials.gov.