The OPENS Trial: Offering Women PrEP (Aim 2)

Completed · Not applicable

Conditions studied: Human Immunodeficiency Virus, Human Immunodeficiency Virus Transmission, Sexually Transmitted Diseases

In brief

To address the significant barriers to pre-exposure prophylaxis (PrEP) implementation for cisgender women 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 the second part (Aim 2) of a multi-component project and involves a patient- and clinic-level intervention in a public health family planning clinic in Duval County Florida, where most patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed 1) a tablet-based decision support tool (DST) that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV, and 2) clinic-wide trainings regarding shared decision making and trauma informed care. In Aim 1 (previously completed), participants were randomized to viewing an HIV prevention DST in a clinic that had not received clinic-wide trainings. In Aim 2 (the present study), there will be two phases. In the first phase, participants will receive care at the clinic following training; the DST will not be used. In the second phase, in addition to being seen at a clinic-site that has experienced the training, participants will use the DST before their visit. Participants will be surveyed about experiences with HIV prevention counseling, intentions about using HIV prevention, and DST use (among those in the active arm in the second phase). A subset of participants, individuals who self-identify as Black or Latinx, will also complete a post-clinic visit interview. The investigators will assess whether participants initiated an HIV prevention method three months following their initial 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.

Key facts

Study ID

NCT05619497

Run by

University of California, San Francisco

People needed

141

Starts

2022-12-02

Expected to finish

2024-11-01

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Self-identify as a woman (regardless of pregnancy status)
• Age 18 years - 45 years
• Not known to be living with HIV (based on self-report)
• English speaking
• Interested in participating in the study

You may not qualify if…

• 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

Where it is running

• Florida Department of Health, Duval County — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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