The OPENS Trial: Offering Women PrEP (Aim 1)
Condition: Human Immunodeficiency Virus Transmission; Sexually Transmitted Diseases
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Sexually Transmitted Diseases
Study type: Interventional

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.
    

Intervention name(s): HIV Prevention Decision Support Tool (DST); Standard Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Participants in this arm will receive usual care.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Health Services Research
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