跳至主要内容
临床试验/NCT06785038
NCT06785038进行中(未招募)不适用

Encouraging Multiple PrEP Options for Women Engaged in PRimary Care

Northwestern University2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2025年5月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
132
试验地点
2
主要终点
PrEP Knowledge

研究概览

简要总结

This study will address the significant yet often overlooked problem of HIV among cisgender women. To do this, researchers will adapt and test a multilingual technology-based strategy supporting informed decision-making for PrEP in primary care. Specifically, researchers will use the electronic health record to securely send women multimedia educational materials in English or Spanish about PrEP, and facilitate electronic scheduling of PrEP visits - if women decide they are interested. Choice is critical.

详细描述

This study will adapt and pilot test a technology-enabled, primary care-based, health literacy strategy to empower women with increased vulnerability to HIV to make informed decisions about PrEP.

Nearly 20% of new HIV infections in the United States (US) occur among cisgender women, with women of color disproportionately affected. Pre-exposure prophylaxis (PrEP) is a safe, effective, and empowering option for HIV prevention women can initiate and use without partner negotiation. Yet most women are unaware PrEP is an option for them. With primary care representing the frontline of healthcare for most adult women, it is an ideal setting to promote PrEP awareness and informed decision-making. Importantly, women themselves have asked for PrEP discussions to be normalized in primary care and multiple studies have shown that women value talking with clinicians about PrEP. Unfortunately, many primary care providers (PCPs) lack the time, resources, and experience needed to counsel women on PrEP during busy, routine visits. Our proposed R34 Encouraging Multiple PrEP Options for Women Engaged in PRimary Care (EMPOWER) therefore offers a pragmatic and innovative approach to the delivery of PrEP information to women in primary care. The EMPOWER strategy addresses well-documented barriers and 'missed opportunities' for HIV prevention among cisgender women and supports informed PrEP decision-making by: 1) identifying women in primary care; 2) delivering understandable, actionable, and non-stigmatizing PrEP education, in multiple formats and languages, directly and securely to women via the patient portal; 3) enabling women to discreetly self-schedule a visit to discuss PrEP options with either their own PCP or with a female PCP who has years of experience in PrEP delivery; and 4) supporting PCP counseling via clinical decision support that provides standardized, patient-centered language to guide PrEP discussions and 'smart sets' to facilitate PrEP prescribing, when desired. Our specific aims are to: 1) Adapt and coordinate the EMPOWER strategy to support informed decision-making among diverse cisgender women with increased vulnerability to HIV seen in primary care; 2) Pilot test the efficacy of the EMPOWER strategy, compared to an attention control, on PrEP knowledge, stigma, and future intention to use PrEP; and 3) Assess the reach, adoption, implementation, and maintenance of EMPOWER components. EMPOWER will be evaluated in Cook County, an 'Ending the HIV Epidemic' priority area. The study will be meaningfully informed by a community advisory board of diverse women, a scientific advisory board of clinicians and experts, and a community collaboration board of local organization leaders in the field of HIV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Participants must:
  • •identify as a cisgender woman
  • •be aged 18 years or older
  • •speak English or Spanish
  • •be a primary care patient at the participating health center
  • •have an active patient portal account
  • •be HIV negative
  • •have never been prescribed PrEP

排除标准

  • •Individuals will be excluded if they have any:
  • •- severe, uncorrectable vision, hearing, or cognitive impairments that would preclude study consent or participation

研究组 & 干预措施

EMPOWER Strategy

Experimental

干预措施: EMPOWER Strategy (Behavioral)

Attention Control

Other

干预措施: Attention Control (Behavioral)

结局指标

主要结局

PrEP Knowledge

时间窗: Two to 4 weeks after women are sent materials (attention control or EMPOWER Strategy) in their patient portal accounts

PrEP knowledge is our primary outcome. We will use an adapted version of an existing PrEP knowledge scale by Walsh (2019). Participants will be asked 13 questions, each with true, false or don't know response options. The number of correct answers will be summed and expressed as percentage correct. Higher scores will represent greater PrEP knowledge.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stacy C Bailey

Professor

Northwestern University

研究点 (2)

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