The OPENS Trial: Offering Women PrEP (Aim 2)

Summary

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.

Conditions

• Human Immunodeficiency Virus
• Human Immunodeficiency Virus Transmission
• Sexually Transmitted Diseases

Interventions

OTHER

Clinic-wide Trainings

The clinic-wide trainings combine principles of shared decision-making and trauma informed care to inform providers and clinic staff of an equitable approach to offering HIV prevention information. These care delivery approaches have been used in health education and counseling in a range of contexts and are effective strategies for care provision. Participants in this arm will receive care from providers and staff who received training.

OTHER

Clinic-wide Trainings and HIV Prevention Decision Support Tool (DST)

The clinic-wide trainings combine principles of shared decision-making and trauma informed care to inform providers and clinic staff of an equitable approach to offering HIV prevention information. These care delivery approaches have been used in health education and counseling in a range of contexts and are effective strategies for care provision. Participants in this arm will receive care from providers and staff who received training. The DST is founded on principles of decision-science and will address barriers to PrEP delivery. The DST will present HIV prevention information through a tablet in the clinical setting. The tool provides information about vulnerabilities to HIV and core characteristics of different HIV prevention methods, and the opportunity to explore these characteristics in depth, including efficacy, safety and side effects. The tool emphasizes the highly variable and individual nature of baseline risk.

OTHER

Standard Care with the HIV Prevention Decision Support Tool (DST)

Participants in this arm will receive usual care at a clinic that has not received training in shared decision making and trauma informed care. These participants will view the decision support tool. These participants were recruited in Aim 1 of this study.

Sponsors & Collaborators

• Florida Department of Health

  collaborator OTHER_GOV

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Christine Dehlendorf, MD, MAS · University of California, San Francisco

• Akilah Pope, MD · Florida Department of Health, Duval County

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-02

Primary Completion

2024-10-08

Completion

2024-11-01

Countries

• United States

Study Locations