Evaluating the Feasibility and Acceptability of a Digital Pre-Exposure Prophylaxis Navigation and Activation Intervention for Racially and Ethnically Diverse Sexual and Gender Minority Youth (PrEPresent): Protocol for a Pilot Randomized Controlled Trial.
Evaluating the Feasibility and Acceptability of a Digital Pre-Exposure Prophylaxis Navigation and Activation Intervention for Racially and Ethnically Diverse Sexual and Gender Minority Youth (PrEPresent): Protocol for a Pilot Randomized Controlled Trial.
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DOI：
10.2196/50866
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发表时间：
2023-09-29
影响因子：
1.7
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为了到2030年终结艾滋病毒流行，我们必须加倍努力，使预防干预措施既适合男男性行为青年，也适合跨性别青年和非双性恋青年。迫切需要采取干预措施，特别关注性和性别少数群体青年（SGMY）人群的暴露前预防（PrEP）摄入。有几个因素会影响SGMY成功参与艾滋病毒预防连续体的能力，包括PrEP的吸收。患者激活，拥有管理自己健康的知识、技能和自我效能，是自主管理自己健康和护理的意愿和能力的重要指标。患者导航在帮助SGMY获得PrEP和PrEP护理方面也发挥着重要作用，因为导航员帮助引导患者通过卫生保健系统，建立医疗预约，并获得财务，法律和社会支持。本研究旨在评估数字PrEP导航和激活干预在生活在洛杉矶地区的种族和民族多样化的SGMY样本中的可行性和可接受性。在第一阶段，我们将开展形成性研究，利用来自PrEP护理提供者、导航员和SGMY工作组的关键信息者访谈的定性数据，为PrEPresent的开发提供信息。在第二阶段，我们将用8-10 SGMY完成PrEPresent的两轮可用性测试，评估干预内容和移动医疗服务平台，以确保功能可用，内容被理解。在第三阶段，我们将进行一项随机对照试验，以评估PrEPresent的可行性和可接受性。我们将按1:1的比例随机抽取150名年龄在16-26岁、居住在洛杉矶地区的SGMY，并对参与者进行为期6个月的随访。第一阶段（形成工作）于2021年4月完成。可用性测试于2021年12月完成。截至2023年6月，已有148名参与者参加了PrEPresent试点随机对照试验（第三期）。预计入学将于2023年7月完成，最终结果将于2023年12月公布。PrEPresent干预旨在弥合种族和民族多样化的SGMY在PrEP资格和PrEP吸收方面的差距。通过促进PrEP导航的提供和注重提高患者的积极性，PrEPresent干预有可能对艾滋病毒护理连续体中的PrEP吸收级联产生积极影响，并可作为基于PrEP行为资格而不是基于普遍性别资格的PrEP干预措施的定制模型。ClinicalTrials.gov NCT05281393;https://clinicaltrials.gov/ct2/show/NCT05281393 derr1 - 10.2196/50866
To end the HIV epidemic by 2030, we must double down on efforts to tailor prevention interventions to both young men who have sex with men and transgender and nonbinary youth. There is an urgent need for interventions that specifically focus on pre-exposure prophylaxis (PrEP) uptake in sexual and gender minority youth (SGMY) populations. There are several factors that impact the ability of SGMY to successfully engage in the HIV prevention continuum, including uptake of PrEP. Patient activation, having the knowledge, skills, and self-efficacy to manage one’s health, is an important indicator of willingness and ability to manage one’s own health and care autonomously. Patient navigation also plays an important role in helping SGMY access PrEP and PrEP care, as navigators help guide patients through the health care system, set up medical appointments, and get financial, legal, and social support. This study aims to evaluate the feasibility and acceptability of a digital PrEP navigation and activation intervention among a racially and ethnically diverse sample of SGMY living in the Los Angeles area. In phase 1, we will conduct formative research to inform the development of PrEPresent using qualitative data from key informant interviews involving PrEP care providers and navigators and working groups with SGMY. In phase 2, we will complete 2 rounds of usability testing of PrEPresent with 8-10 SGMY assessing both the intervention content and mobile health delivery platform to ensure features are usable and content is understood. In phase 3, we will conduct a pilot randomized controlled trial to evaluate the feasibility and acceptability of PrEPresent. We will randomize, 1:1, a racially and ethnically diverse sample of 150 SGMY aged 16-26 years living in the Los Angeles area and follow participants for 6 months. Phase 1 (formative work) was completed in April 2021. Usability testing was completed in December 2021. As of June 2023, 148 participants have been enrolled into the PrEPresent pilot randomized controlled trial (phase 3). Enrollment is expected to be completed in July 2023, with final results anticipated in December 2023. The PrEPresent intervention aims to bridge the gaps in PrEP eligibility and PrEP uptake among racially and ethnically diverse SGMY. By facilitating the delivery of PrEP navigation and focusing on improving patient activation, the PrEPresent intervention has the potential to positively impact the PrEP uptake cascade in the HIV care continuum as well as serve as a model for the tailoring of PrEP interventions based on behavior-based qualifications for PrEP instead of generalized gender-based eligibility. ClinicalTrials.gov NCT05281393; https://clinicaltrials.gov/ct2/show/NCT05281393 DERR1-10.2196/50866