The OPENS Trial: Offering Women PrEP (Aim 1)

Study Overview
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Brief Summary
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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: 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. 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. 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
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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.

Official Title
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Offering Women PrEP With Education and Shared Decision-making

Conditions
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Human Immunodeficiency Virus Transmission, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: HIV Prevention Decision Support Tool (DST)
* Behavioral: Standard Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV Prevention DST Intervention<br>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)<br>* 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.<br>|
| Active Comparator: Standard Counseling<br>Participants in this arm will receive usual care. | Behavioral: Standard Counseling<br>* Participants in this arm will receive usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Reporting PrEP use | Patients will be contacted at follow-up and asked if they took PrEP in the past 3 months regardless of where it was obtained. Outcome is dichotomous (yes, initiated PrEP within 3 months of initial visit or no, did not initiate PrEP within 3 months of initial visit). | 3 months post baseline visit | 
| Change in Patient-Perceived HIV risk | We will measure the change in HIV risk perception in the next 6 months from pre- to post-visit at baseline. Response options include 4-point scale: 1 (Not at all worried) to 4 (Extremely worried). | Baseline, pre-intervention compared to immediately post baseline visit | 
| Patient-Perceived HIV risk | Participants will be asked about how worried they are about getting HIV in the next 6 months. Response options include 4-point scale of 1 (Not at all worried) to 4 (Extremely worried). | Immediately post baseline visit | 
| PrEP Knowledge | Proportion of participants selecting the correct response to knowledge questions. Response options for each item are different. Higher score represents greater knowledge. | Immediately post baseline visit | 
| Decisional Conflict - Total Score | 16-item scale to measure decisional conflict. Response options range from 1-5 strongly disagree to strongly agree. Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict]. Higher scores represent high decisional conflict. | Immediately post baseline visit | 
| Decisional Conflict - Uncertainty Subscore | Three items from the Decisional Conflict scale will measure uncertainty: I am clear about the best choice for me, I feel sure about what to choose, and the decision is easy for me to make. Response options range from 1-5 strongly disagree to strongly agree. Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [feels extremely certain about best choice] to 100 [feels extremely uncertain about decision]. Higher scores represent greater decision uncertainty. | Immediately post baseline visit | 
| Decisional Conflict - Informed Subscore | Three items from the Decisional Conflict scale will measure the informed subscale: I know which options are available to me, I know the benefits of each option, and I know the risks and side effects of each option. Response options range from 1-5 strongly disagree to strongly agree. Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [feels extremely informed] to 100 [feels extremely uninformed]. Higher scores represent a greater degree of feeling uninformed. | Immediately post baseline visit | 
| Decisional Conflict - Values Clarity Subscore | Three items from the Decisional Conflict scale will measure values clarity: I am clear about which benefits matter the most to me, I am clear about which risks and side effects matter most to me, and I am clear about which is more important to me (the benefits or the risks and side effects. Response options range from 1-5 strongly disagree to strongly agree. Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [feels extremely clear about personal values for benefits and risks/side effects] to 100 [feels extremely unclear about personal values]. | Immediately post baseline visit | 
| Decisional Conflict - Support Subscore | Three items from the Decisional Conflict scale will measure support: I have enough support from others to make a choice, I am choosing without pressure from others, and I have enough advice to make a choice. Response options range from 1-5 strongly disagree to strongly agree. Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [feels extremely supported in decision making] to 100 [feels extremely unsupported in decision making]. | Immediately post baseline visit | 
| Decisional Conflict - Effective Decision Subscore | Four items from the Decisional Conflict scale will measure effective decision: I feel I have made an informed choice, my decision shows what is important to me, I expect to stick with my decision, and I am satisfied with my decision. Response options range from 1-5 strongly disagree to strongly agree. Items will be reverse-coded. Mean scores will be calculated, subtracted by 1, and multiplied by 25; scores range from 0 [good decision] to 100 [bad decision]. | Immediately post baseline visit | 
| Interpersonal Quality of HIV Prevention Care | Mean score of 4-item scale. Derived from the Person-Centered Contraceptive Care measure developed by the PI. Response options consist of 5-point Likert scale: 1 (strongly disagree) to 5 (strongly agree). Scores will be dichotomized between 20 [excellent interpersonal quality of care] and less than 20 [poor interpersonal quality of care]. | Immediately post baseline visit | 
| Intention to Use Any HIV Prevention Method | A one-time, one-item measure of plan to use HIV prevention method after the initial visit. Participants can select from none, condoms, PrEP, post exposure prophylaxis (PEP), treatment as prevention, regular HIV testing (inclusive of partner), still thinking about my options, or other method. | Immediately post baseline visit | 
| Confidence in decision to use an HIV prevention method | A one-time, one-item measure of certainty of plan to use HIV prevention after the initial visit. Participants can select from 4 options: 1 (completely unsure), 2 (mostly unsure), 3 (mostly sure, but not 100%), or 4 (100% sure). | Immediately post baseline visit | 
| Satisfaction with Information Received about HIV Prevention | Participants will be asked a one-time question regarding satisfaction with HIV prevention counseling. Response options include: 1 (I was not given any information about HIV), 2 (very unsatisfied) 3 (somewhat unsatisfied), 4 (neither satisfied or unsatisfied), 5 (somewhat satisfied) and 6 (very satisfied). | Immediately post baseline visit | 
| Perceived Quality of Information Received about HIV Prevention | Participants will be asked four questions about the perceived quality of the HIV prevention information patients received during their health care visit: 1) getting the information they needed, 2) the ease of understanding the information, 3) the trustworthiness of the information, and 4), the usefulness of the information. These questions will be asked of those who reported talking about HIV/HIV prevention during their visit with the healthcare provider or health educator OR those who talked to the healthcare provider or health educator about their chances of getting HIV. Response options are 1 to 5 strongly disagree to strongly agree. Higher values indicate greater perceived quality. | Immediately post baseline visit | 
| Acceptability of HIV Prevention Methods | Participants are asked to rate their preference for a method (even if they never used it). Participants can select from condoms, PrEP, PEP, partner HIV testing, regular STD testing, treatment as prevention or other method. The option, never heard of it is also included. Options for this scale range from 0 (Terrible method for me) to 10 (Great method for me). | Immediately post baseline visit | 
| Acceptability of the Decision Support Tool | Participants are asked four questions about their experiences using the DST (e.g., degree to which they got all the information they needed, found the information to be easy to understand, trust the information, and found information useful). Response items vary from strongly disagree to strongly agree. | Immediately post baseline visit | 
| Perception of the Decision Support Tool | Participants in the experimental arm will be asked about the degree to which they liked/disliked the tool. Response options vary: I did not like it at all, I somewhat disliked it, I somewhat liked it, I really liked it. | Immediately post baseline visit | 
| Satisfaction with the Decision Support Tool | Participants in the experimental arm will be asked about the degree to which they were satisfied with the information in the tool. Response options vary from 1-5: very unsatisfied to very satisfied. | Immediately post baseline visit | 
| Recommend the Decision Support Tool | Participants in the experimental arm will be asked whether they would recommend the tool a friend. Response options are yes, no, unsure. | Immediately post baseline visit | 
| Willingness to Use the Decision Support Tool at Future Visits | Participants in the experimental arm will be asked about whether they would use the tool again if they returned to the clinic. Response options are yes, no, unsure. | Immediately post baseline visit | 
| HIV Prevention Method Use (any method - planned or new method) | A self-reported measure of HIV prevention method use, including those who reported discontinuing the initial HIV prevention method(s) that were reported post-clinic visit. A response of yes to any of the following questions: since your [baseline] visit, have you used….for HIV prevention - abstinence, condoms, PEP, PrEP, regular HIV testing, treatment as prevention, regular sexually transmitted disease (STD) testing, other method. The outcome will be dichotomized to those who responded affirmatively vs other responses (no/unsure). | 3 months post baseline visit | 
| HIV Prevention Method Continuation | A self-reported measure of HIV prevention method continuation. A response of yes to any of the following questions: are you still using - abstinence, condoms, PEP, PrEP, regular HIV testing, treatment as prevention, regular sexually transmitted disease (STD) testing, other method. The outcome will be dichotomized to those who responded yes vs no. | 3 months post baseline visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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