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临床试验/NCT05619497
NCT05619497已完成不适用

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

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2022年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
2
主要终点
PrEP Prescriptions (As Measured by Chart Review)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

PrEP Prescriptions (As Measured by Chart Review)

时间窗: 3 months post baseline visit

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 at initial visit/No, did not receive a PrEP prescription at initial visit).

次要结局

  • PrEP Knowledge(Immediately post baseline visit)
  • Number of Patients Reporting PrEP Use(3 months post baseline visit)
  • Change in Patient-Perceived HIV risk(Baseline, pre-intervention compared to immediately post baseline visit)
  • Decisional Conflict - Total Score(Immediately post baseline visit)
  • Decisional Conflict - Informed Subscore(Immediately post baseline visit)
  • Decisional Conflict - Values Clarity Subscore(Immediately post baseline visit)
  • Decisional Conflict - Effective Decision Subscore(Immediately post baseline visit)
  • Interpersonal Quality of HIV Prevention Care(Immediately post baseline visit)
  • Decisional Conflict - Uncertainty Subscore(Immediately post baseline visit)
  • Patient-Perceived HIV risk(Immediately post baseline visit)
  • Decisional Conflict - Support Subscore(Immediately post baseline visit)
  • Recommend the Decision Support Tool(Immediately post baseline visit)
  • Acceptability of HIV Prevention Methods(Immediately post baseline visit)
  • Acceptability of the Decision Support Tool(Immediately post baseline visit)
  • Perception of the Decision Support Tool(Immediately post baseline visit)
  • Interpersonal Quality of Health Services(Immediately post baseline visit)
  • Intention to Use Any HIV Prevention Method(Immediately post baseline visit)
  • Confidence in Decision to Use an HIV Prevention Method(Immediately post baseline visit)
  • Satisfaction with the Decision Support Tool(Immediately post baseline visit)
  • HIV Prevention Method Continuation(3 months post baseline visit)
  • Willingness to Use the Decision Support Tool at Future Visits(Immediately post baseline visit)
  • HIV Prevention Method Use (any method - planned or new method)(3 months post baseline visit)
  • Satisfaction with Information Received about HIV Prevention(Immediately post baseline visit)
  • Perceived Quality of Information Received about HIV Prevention(Immediately post baseline visit)
  • Perceived Quality of Health Information Received(Immediately post baseline visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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