The OPENS Trial: Offering Women PrEP (Aim 1)

NCT04621760 | Completed Results

• 2 other identifiers: 2020-014-FDOH3R01MD013565
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Keywords

Pre-exposure prophylaxis (PrEP); HIV prevention behaviors; HIV prevention methods; HIV education; African American, Latina, women of color; Shared decision making; Decision making, shared; Patient decision support; Patient decision aid

Outcome Measures

Primary Outcomes (1)

• PrEP Prescriptions (As Measured by Chart Review)

  The number of participants who received a PrEP prescription within 3 months of their baseline visit, obtained by chart extraction from the medical record. Outcome is dichotomous (Yes, received a PrEP prescription /No, did not receive a PrEP prescription).

  3 months post baseline visit

Secondary Outcomes (23)

• Number of Patients Reporting PrEP Use

  3 months post baseline visit

• Change in Patient-Perceived HIV Risk

  Baseline, pre-intervention compared to immediately post baseline visit

• Patient-Perceived HIV Risk

  Immediately post baseline visit

• PrEP Knowledge

  Immediately post baseline visit

• Decisional Conflict - Total Score

  Immediately post baseline visit

Study Arms (2)

HIV Prevention DST Intervention

EXPERIMENTAL

Participants in this arm will receive the HIV prevention DST intervention and will receive the intervention immediately before their provider visit.

Behavioral: HIV Prevention Decision Support Tool (DST)

Standard Counseling

ACTIVE COMPARATOR

Participants in this arm will receive usual care.

Behavioral: Standard Counseling

Interventions

HIV Prevention Decision Support Tool (DST) BEHAVIORAL

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.

HIV Prevention DST Intervention

Standard Counseling BEHAVIORAL

Participants in this arm will receive usual care.

Standard Counseling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Participants have to identify as a woman.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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
• Already participated in the study

Sponsors & Collaborators

• University of California, San Francisco: lead
• Florida Department of Health: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Florida Department of Health in Duval County

Jacksonville, Florida, 32211, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

COVID-19 disrupted normal clinic operations, including limiting HIV/PrEP counseling, and paused a state-wide PrEP campaign for cisgender women. This study was conducted at a single, publicly funded clinic with few providers and recruited primarily English-speaking participants and is not generalizeable to other populations. Further, there were too few participants who identified as non-cisgender women or reported injection drug use to report on experiences of those populations.

Results Point of Contact

• Title: Dr. Dominika Seidman
• Organization: University of California, San-Francisco

Dominika.Seidman@ucsf.edu

(415) 353-2119

Study Officials

• Christine Dehlendorf, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Akilah Pope, MD

  Florida Department of Health in Duval County

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: HIV Prevention Decision Support Tool (DST) - An interactive, tablet-based decision support tool that is designed to help women consider options to reduce their risk of HIV, with emphasis on PrEP as an emerging HIV prevention tool for women.

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: November 9, 2020
• Study Start: May 3, 2021
• Primary Completion: October 24, 2022
• Study Completion: November 4, 2022
• Last Updated: May 20, 2024
• Results First Posted: May 20, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)