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N/A N=189 Randomized Health Services Research

The OPENS Trial: Offering Women PrEP (Aim 1)

Human Immunodeficiency Virus Transmission · Sexually Transmitted Diseases

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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