The OPENS Trial: Offering Women PrEP (Aim 2)

NCT05619497 | Completed

• 2 other identifiers: IRB # 2020-014-FDOH3R01MD013565
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pre-exposure prophylaxis (PrEP); HIV prevention behaviors; HIV prevention methods; HIV education; African American, Latina, women of color; Shared decision making; Shared decision-making; Decision making, shared; Trauma informed care; Trauma-informed care; Patient decision support; Patient decision aid; Public health clinic; Health department clinic; Southeastern U.S.

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 at initial visit/No, did not receive a PrEP prescription at initial visit).

  3 months post baseline visit

Secondary Outcomes (25)

• 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 (4)

Care Post Clinic-Wide Trainings

ACTIVE COMPARATOR

Participants in this arm will receive care in a clinic where providers and staff have been trained in shared decision making and trauma-informed care. Participants in this arm will not view the decision support tool in this phase.

Other: Clinic-wide Trainings

Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST)

EXPERIMENTAL

Participants in this arm will receive care in a clinic where providers and staff have been trained in shared decision making and trauma informed care, and receive the HIV prevention DST intervention immediately before their provider visit.

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

Standard Care without the HIV Prevention Decision Support Tool (DST)

NO INTERVENTION

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 also will not have viewed the HIV prevention DST. These participants were recruited in Aim 1 of this study.

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

ACTIVE COMPARATOR

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 HIV prevention DST. These participants were recruited in Aim 1 of this study.

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

Interventions

Clinic-wide Trainings OTHER

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.

Care Post Clinic-Wide Trainings

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

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.

Care Post Clinic-Wide Training and HIV Prevention Decision Support Tool (DST)

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

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.

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Anyone who self identifies 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 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

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, Duval County

Jacksonville, Florida, 32211, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Christine Dehlendorf, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Akilah Pope, MD

  Florida Department of Health, Duval County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 17, 2022
• Study Start: December 2, 2022
• Primary Completion: October 8, 2024
• Study Completion: November 1, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)