N/A
N=189
The OPENS Trial: Offering Women PrEP (Aim 1)
Human Immunodeficiency Virus Transmission · Sexually Transmitted Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04621760 ↗Enrolled (actual)
189
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: PrEP Prescriptions (As Measured by Chart Review) — 1; 0 Participants — p=0.51
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIV Prevention Decision Support Tool (DST) (Behavioral); Standard Counseling (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PrEP Prescriptions (As Measured by Chart Review) |
1; 0 | 0.51 |
| SECONDARY Number of Patients Reporting PrEP Use |
1; 1 | 0.62 |
| SECONDARY Change in Patient-Perceived HIV Risk |
77; 85; 9; 3; 6; 2 | 0.207 |
| SECONDARY Patient-Perceived HIV Risk |
2; 4; 4; 1; 11; 13 | 0.496 |
| SECONDARY PrEP Knowledge |
54; 37; 75; 58; 30; 16 | 0.02 sig |
| SECONDARY Decisional Conflict - Total Score |
10; 0 | 0.04 sig |
| SECONDARY Decisional Conflict - Uncertainty Subscore |
16.7; 0 | 0.02 sig |
| SECONDARY Decisional Conflict - Informed Subscore |
0; 0 | 0.05 |
| SECONDARY Decisional Conflict - Values Clarity Subscore |
12.5; 0 | 0.03 sig |
| SECONDARY Decisional Conflict - Support Subscore |
6.3; 0 | 0.07 |
| SECONDARY Decisional Conflict - Effective Decision Subscore |
16.7; 0 | 0.10 |
| SECONDARY Interpersonal Quality of HIV Prevention Care |
17.2; 16.9 | 0.22 |
| SECONDARY Intention to Use Any HIV Prevention Method |
88; 87; 38; 39; 77; 77 | 0.51 |
| SECONDARY Confidence in Decision to Use an HIV Prevention Method |
2; 2; 1; 2; 6; 4 | 0.90 |
| SECONDARY Satisfaction With Information Received About HIV Prevention |
77; 60; 9; 10; 3; 9 | 0.01 sig |
| SECONDARY Perceived Quality of Information Received About HIV Prevention |
35; 31; 37; 31; 35; 32 | 0.26 |
| SECONDARY Acceptability of HIV Prevention Methods |
27; 29; 35; 40; 18; 14 | 0.74 |
| SECONDARY Acceptability of the Decision Support Tool |
82; 0; 81; 0; 83; 0 | — |
| SECONDARY Perception of the Decision Support Tool |
66; 0; 18; 1 | — |
| SECONDARY Satisfaction With the Decision Support Tool |
69; 0; 10; 5; 1; 7 | — |
| SECONDARY Recommend the Decision Support Tool |
81; 0 | — |
| SECONDARY Willingness to Use the Decision Support Tool at Future Visits |
63; 0 | — |
| SECONDARY HIV Prevention Method Use (Any Method - Planned or New Method) |
53; 49 | 0.13 |
| SECONDARY HIV Prevention Method Continuation |
53; 48 | 0.08 |
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 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.
Eligibility Criteria
Inclusion Criteria
- Self-identify as a woman (regardless of pregnancy status)
- Age 18 - 45 years
- Not known to be living with HIV (based on self-report)
- English-speaking
- Interested in participating
Exclusion Criteria
- Unable to consent
- Currently using PrEP
- Those who were assigned male at birth and self-identify as a man
- Unwilling to be contacted in 3 months
- Already participated in the study
Data sourced from ClinicalTrials.gov (NCT04621760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.