Clinical trial NCT05619497: The OPENS Trial: Offering Women PrEP (Aim 2)
Official title: Offering Women PrEP With Education and Shared Decision-making (Aim 2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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.
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: 2022-11-17
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

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. Lastly, there is often limited time to educate patients in busy clinics. 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 emphasizes the variable and individual nature of baseline risk. It provides information on the 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 to facilitate deliberation with the provider. The DST takes approximately 10 minutes to complete. A decision support tool was chosen as a key component of the study following its proven effectiveness in offering contraceptive options to patients. The HIV prevention DST was tested in Aim 1 of this study: participants were randomized to viewing the DST or not, prior to receiving usual care.

Additionally, the study team recognizes the importance of receiving health information from a trusted source, such as health care providers or health educators, when making important health decisions. Therefore, this study (Aim 2) will offer and assess the effects of a combined intervention of the DST following a clinic-wide training on shared decision making and trauma-informed care. Shared decision making is an effective strategy to offer information and services to patients as it allows the health care provider to share their clinical knowledge and expertise while partnering with the patient to elicit their experiential knowledge, needs and preferences. Through partnership between a patient and provider, the patient can make an informed decision about HIV prevention and other health needs that align with their values and desires and can result in greater adherence to the prevention or treatment options and satisfaction with care. The training will also include information about trauma-informed approaches to deliver health care in a person-centered and affirming manner. This training will highlight how many people, particularly those vulnerable to HIV due to intersecting oppressions, carry traumas that impact their exposure to health issues and the resources needed to mitigate these harms. It is critical that health care providers and health professionals are aware of intersecting forms of oppression that create trauma, including those that the medical profession create and perpetuate. A combined approach of shared decision making at the interpersonal level and trauma informed care at the clinic-level is an equity-oriented strategy to offering HIV prevention information to women in the Southeastern U.S. who are disproportionately impacted by HIV.

Approximately 366 individuals who self-identify as women presenting to one reproductive health clinic in Duval County, Florida, will be recruited to the study in Aim 2, with 183 enrolled in each of the two phases. As the decision support tool is primarily focused on cisgender women, participants who do not identify as cisgender will be included in the study, but their study data will be analyzed separately. In the first phase of Aim 2 of the study, participants will receive care as usual at a clinic site after the trainings have been held for staff. In the second phase of Aim 2, participants will receive care at this same clinic that has been exposed to the training and will also view the HIV prevention DST. These participants will be compared to those recruited in Aim 1 of this study, in which participants accessed care from the same clinic prior to clinic-wide trainings, and half of participants viewed the HIV prevention DST.

In addition to these interventions, a subset of 40 participants (20 per phase) will be asked to allow audio-recording of their counseling sessions with a provider. A subset of up to 40 additional participants (20 per phase), 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. Those who participated in Aim 1, are not excluded from participating in Aim 2 however, they will not be eligible to participate in an interview.

Hypotheses:

1. Women who receive care at a clinic following clinic-wide trainings on shared decision making and trauma informed care are more likely to initiate PrEP as compared to women who received care at the same clinic prior to training.
2. In a clinic that received clinic-wide trainings in shared decision making and trauma informed care, women who use the HIV prevention decision support tool are more likely to initiate PrEP as compared to women who did not use the tool.
3. Women who receive care at a clinic following clinic-wide training on shared decision making and trauma informed care and who also used the decision support tool are more likely to initiate PrEP as compared to women who receive care at the same clinic prior to training and did not use the tool.
4. Women who receive care at a clinic following clinic-wide trainings on shared decision making and trauma informed care and who also used the decision support tool are more likely to initiate PrEP as compared to those who receive care at the same clinic prior to training and used the DST.

Eligibility criteria: Inclusion Criteria:

* 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

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

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: Interpersonal Quality of Health Services
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: Perceived Quality of Health Information Received
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, Duval County
state: Florida
Study officials:
affiliation: University of California, San Francisco
name: Christine Dehlendorf, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Department of Health, Duval County
name: Akilah Pope, MD
role: PRINCIPAL_INVESTIGATOR
References: