COMPLETED

The OPENS Trial: Offering Women PrEP (Aim 2)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Offering Women PrEP With Education and Shared Decision-making (Aim 2)

Quick Facts

Study Start:2022-12-02
Study Completion:2024-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05619497

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-identify as a woman (regardless of pregnancy status)
  2. * Age 18 years - 45 years
  3. * Not known to be living with HIV (based on self-report)
  4. * English speaking
  5. * Interested in participating in the study
  1. * Unable to consent
  2. * Currently using PrEP
  3. * Those who were assigned male at birth and self-identify as a man
  4. * Unwilling to be contacted in 3 months

Contacts and Locations

Principal Investigator

Christine Dehlendorf, MD, MAS
PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Akilah Pope, MD
PRINCIPAL_INVESTIGATOR
Florida Department of Health, Duval County

Study Locations (Sites)

Florida Department of Health, Duval County
Jacksonville, Florida, 32211
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Christine Dehlendorf, MD, MAS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
  • Akilah Pope, MD, PRINCIPAL_INVESTIGATOR, Florida Department of Health, Duval County

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-02
Study Completion Date2024-11-01

Study Record Updates

Study Start Date2022-12-02
Study Completion Date2024-11-01

Terms related to this study

Keywords Provided by Researchers

  • 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.

Additional Relevant MeSH Terms

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