The OPENS Trial: Offering Women PrEP (Aim 1)

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.

Conditions

• Human Immunodeficiency Virus Transmission
• Sexually Transmitted Diseases

Interventions

BEHAVIORAL

HIV Prevention Decision Support Tool (DST)

The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk.

BEHAVIORAL

Standard Counseling

Participants in this arm will receive usual care.

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 · University of California, San Francisco

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

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-03

Primary Completion

2022-10-24

Completion

2022-11-04

Countries

• United States

Study Locations