Clinical trial NCT04621760: The OPENS Trial: Offering Women PrEP (Aim 1)
Official title: Offering Women PrEP With Education and Shared Decision-making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-11-09
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

Detailed description: Although 13% of the U.S. female population is Black, 60% of new HIV diagnoses in U.S. women occur among Black women. The South is the epicenter of the U.S. HIV epidemic, including in women, and Black Southern women are disproportionately affected: Black women account for 69% of new HIV diagnoses in women in the South. As the first highly effective, discrete, woman-controlled HIV prevention method, oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine radically expands HIV prevention options for women. However, uptake of PrEP in U.S. women has lagged, particularly among groups most affected by HIV.

PrEP cascades outline the necessary steps for accessing PrEP, including screening and identifying eligible individuals, linkage to care, prescription, and initiation of PrEP. Data suggest there are multilevel barriers related to the process of screening for HIV risk in women and identifying potential PrEP candidates that may drive a significant drop off early in the PrEP cascade for women. Women report feeling judged by risk assessment questions and experience stigma around disclosing sexual practices. As a result, if screening is required to educate patients about PrEP - as is true in most clinical settings - many women for whom PrEP is appropriate may never learn about PrEP. Further, women have low levels of knowledge about HIV risk and HIV prevention options, and therefore will not seek out PrEP services themselves. By offering education to all women about vulnerabilities to HIV as well as information about HIV prevention methods including PrEP, at-risk women can circumvent these multifactorial barriers and request PrEP. Electronic decision support tools (DST), which have been used with success in a range of healthcare contexts including contraception, provide an efficient and private mechanism for this information-sharing step.

The study team developed a tablet-based tool that is designed to provide universal PrEP education and facilitate women's agency to identify their own risks and interest in PrEP. It was refined with iterative feedback from patient and community stakeholders and finalized based on cognitive testing.

The DST provides information about vulnerabilities to HIV and core characteristics of different HIV prevention methods, and then the opportunity to explore these characteristics in depth, including efficacy, safety and side effects. The user chooses the level of information that they wish to receive through the interactive interface, allowing for an individualized experience. Upon reaching the end of the tool, information on the tablet suggests that women ask their provider about HIV prevention methods they are interested in using, based on their preferences for method characteristics, and their questions in order to facilitate deliberation with the provider. The DST takes approximately 10 minutes to complete.

Approximately 200 women presenting to one reproductive health clinic in Duval County, Florida, will be randomized to standard counseling plus use of an HIV prevention DST, providing education about PrEP and encouraging self-assessment of HIV risk, or standard counseling alone. In addition to the experimental intervention, a subset of 40 participants (20 per arm) will be asked to allow audio-recording of their counseling sessions with a provider. A subset of up to 40 additional participants (20 per arm), all of whom self-identify as women of color, will be invited to complete one-hour, semi-structured interviews after their clinic visit about their experiences of using the DST, HIV prevention counseling, and decision making about PrEP.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: PrEP Prescriptions (As Measured by Chart Review)
timeFrame: 3 months post baseline visit
Secondary outcomes:
measure: Number of Patients Reporting PrEP Use
timeFrame: 3 months post baseline visit
measure: Change in Patient-Perceived HIV Risk
timeFrame: Baseline, pre-intervention compared to immediately post baseline visit
measure: Patient-Perceived HIV Risk
timeFrame: Immediately post baseline visit
measure: PrEP Knowledge
timeFrame: Immediately post baseline visit
measure: Decisional Conflict - Total Score
timeFrame: Immediately post baseline visit
measure: Decisional Conflict - Uncertainty Subscore
timeFrame: Immediately post baseline visit
measure: Decisional Conflict - Informed Subscore
timeFrame: Immediately post baseline visit
measure: Decisional Conflict - Values Clarity Subscore
timeFrame: Immediately post baseline visit
measure: Decisional Conflict - Support Subscore
timeFrame: Immediately post baseline visit
measure: Decisional Conflict - Effective Decision Subscore
timeFrame: Immediately post baseline visit
measure: Interpersonal Quality of HIV Prevention Care
timeFrame: Immediately post baseline visit
measure: Intention to Use Any HIV Prevention Method
timeFrame: Immediately post baseline visit
measure: Confidence in Decision to Use an HIV Prevention Method
timeFrame: Immediately post baseline visit
measure: Satisfaction With Information Received About HIV Prevention
timeFrame: Immediately post baseline visit
measure: Perceived Quality of Information Received About HIV Prevention
timeFrame: Immediately post baseline visit
measure: Acceptability of HIV Prevention Methods
timeFrame: Immediately post baseline visit
measure: Acceptability of the Decision Support Tool
timeFrame: Immediately post baseline visit
measure: Perception of the Decision Support Tool
timeFrame: Immediately post baseline visit
measure: Satisfaction With the Decision Support Tool
timeFrame: Immediately post baseline visit
measure: Recommend the Decision Support Tool
timeFrame: Immediately post baseline visit
measure: Willingness to Use the Decision Support Tool at Future Visits
timeFrame: Immediately post baseline visit
measure: HIV Prevention Method Use (Any Method - Planned or New Method)
timeFrame: 3 months post baseline visit
measure: HIV Prevention Method Continuation
timeFrame: 3 months post baseline visit
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Florida Department of Health in Duval County
state: Florida
Study officials:
affiliation: University of California, San Francisco
name: Christine Dehlendorf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Department of Health in Duval County
name: Akilah Pope, MD
role: PRINCIPAL_INVESTIGATOR
References: