Optimizing an IMB-guided intervention to support HIV self-testing and PrEP uptake among YMSM: A pilot factorial RCT

优化 IMB 指导的干预措施，以支持 YMSM 中的 HIV 自我检测和 PrEP 吸收：试点因子随机对照试验

• 批准号: 10006590
• 负责人: Steven A John
• 金额: $ 14.59万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-03 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10006590
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Adherence; Affect; Age; Attitude; Behavioral; Blood; Career Mobility; Caring; Clinic; Clinical; Clinical Trials; Counseling; Data; Data Analyses; Development; Devices; Economics; Ethics; Experimental Designs; Face; Focus Groups; Goals; Grant; HIV; HIV Infections; HIV Seropositivity; Human immunodeficiency virus test; Incidence; Individual; Infection; Institutes; Insurance; Intervention; Intervention Studies; Latino; Lesbian Gay Bisexual Transgender; Liquid substance; Manuscripts; Measures; Mentored Research Scientist Development Award; Mentors; Methods; Minnesota; Modeling; Motivation; Oral; Outcome; Participant; Population; Positioning Attribute; Postdoctoral Fellow; Pre-Post Tests; Preparation; Prevention; Prevention Research; Procedures; Productivity; Provider; Public Health; Publishing; Qualitative Methods; Qualitative Research; Randomized; Randomized Controlled Trials; Reporting; Research; Research Activity; Research Design; Research Methodology; Research Personnel; Risk; Role; Route; Sampling; Scientist; Self Administration; Self Efficacy; Spottings; Surveys; Testing; Training; Translating; Treatment Efficacy; United States Food and Drug Administration; Universities; Work; Writing; Youth; aged; arm; base; career; career development; condoms; design; efficacy trial; follow-up; implementation science; improved; mHealth; men who have sex with men; pill; pre-exposure prophylaxis; professor; racial and ethnic disparities; recruit; skills; social stigma; symposium; tenure track; therapy development; transmission process; uptake; young men who have sex with men

PROJECT SUMMARY Men who have sex with men (MSM) are disproportionately affected by HIV, and more than 70% of HIV infections among youth (≤ 24 years old) occur among young MSM (YMSM). US Food and Drug Administration approved oral fluid rapid HIV self-testing (HIVST) devices provide a critical route for reducing barriers to HIV testing; however, uptake of HIVST among YMSM has been slow to date and no known studies have explored barriers and facilitators to HIVST among YMSM using rigorous mixed-methods procedures. YMSM who engage in HIVST are also good candidates for HIV pre-exposure prophylaxis (PrEP), but PrEP uptake among YMSM has been minimal to date. The Information-Motivation-Behavioral Skills (IMB) model is an empirically supported framework for HIV prevention, which can be applied to the barriers and facilitators related to HIVST and PrEP uptake. An IMB-guided mHealth intervention is a promising strategy to increase HIVST and PrEP uptake, offering participant confidentiality and potential scaling of an efficient intervention. Despite the promise of this type of theoretically-guided intervention, little is known about the independent effects of each IMB model construct on HIVST and PrEP uptake. To support intervention development, we will conduct mixed-methods formative research to explore IMB-related barriers and facilitators to HIVST and PrEP uptake among YMSM using data collected via online focus groups (n = 12; 96-144 individuals) with YMSM nationwide and a national survey of YMSM (n = 500; i.e., Aim 1). We will then pilot an IMB-factorial mHealth intervention to increase HIVST and post-test PrEP uptake tailored for YMSM, assessing feasibility, acceptability, and preliminary impact at 3-month follow-up (i.e., Aim 2). The intervention will be reviewed by an online youth advisory board and beta-tested with 12 YMSM. We will then pilot the clinical trial with 120 YMSM randomized to one of four groups using a factorial randomized experimental design, allowing us to determine which IMB model construct(s) are most important to increase HIVST and PrEP uptake. The four arms of this randomized controlled trial will be information-only (I), information + motivation (IM), information + behavioral skills (IB), and full IMB model (IMB). Dried blood spot sampling will be used to measure PrEP uptake and adherence. The training plan of this K01 award is designed to facilitate Dr. Steven A. John's transition to an independent investigator. Specifically, Dr. John will: (1) develop skills in mixed-methods research including advanced training in qualitative research methods, (2) build content expertise in mHealth interventions for HIV prevention, and (3) gain expertise in translating formative work into efficacy trials with supplemental training in quantitative analysis and implementation science. Additional training in responsible and ethical conduct in research and a focus on career enhancement and professional development will accompany the three primary training goals. The training plan includes didactic coursework, independent study, training institutes, academic conferences, manuscript preparation, grant writing, and other research activities.

项目摘要 男男性行为者（MSM）受艾滋病毒影响的比例过高，70%以上的艾滋病毒感染者 青年（≤ 24岁）感染发生在青年男男性行为者（YMSM）中。美国食品和药物管理局 经批准的口服液快速艾滋病毒自我检测（HIVST）设备为减少艾滋病毒感染障碍提供了一条重要途径 测试;然而，YMSM中HIVST的吸收迄今为止一直很慢，没有已知的研究探索 YMSM之间使用严格的混合方法程序的艾滋病毒/艾滋病的障碍和促进因素。YMSM谁 从事艾滋病毒感染者也是艾滋病毒暴露前预防（PrEP）的良好候选人，但 迄今为止，YMSM的规模最小。信息-动机-行为技能（IMB）模型是一个经验性的模型。 支持艾滋病毒预防框架，可适用于与艾滋病毒/艾滋病传播相关的障碍和促进因素 和PrEP摄取。IMB指导的移动健康干预是增加HIVST和PrEP的有希望的策略 吸收，为参与者提供保密性，并有可能扩大有效干预措施的规模。尽管承诺 在这种理论指导的干预中，人们对每种IMB模型的独立效应知之甚少 构建体对HIVST和PrEP摄取的影响。为了支持干预发展，我们将进行混合方法 形成性研究，探索与IMB相关的障碍和促进因素，以促进YMSM接受HIVST和PrEP 使用通过在线焦点小组（n = 12; 96 - 144人）收集的数据，全国范围内有YMSM， YMSM的调查（n = 500;即，目标1）。然后，我们将试行IMB因子移动健康干预，以增加 为YMSM量身定制的HIVST和测试后PrEP摄取，评估可行性，可接受性和初步 3个月随访时的影响（即，目标2）。在线青年咨询委员会将对干预措施进行审查 并使用12 YMSM进行了Beta测试。然后，我们将进行临床试验，将120名YMSM随机分为四组 组使用析因随机实验设计，使我们能够确定哪种IMB模型 构建体对于增加HIVST和PrEP摄取最重要。这个随机化的四个臂 对照试验将是仅提供信息（I）、信息+动机（IM）、信息+行为技能（IB），以及 IMB模型（IMB）干血斑采样将用于测量PrEP吸收和依从性。的 本K01奖项的培训计划旨在促进Steven A.约翰向独立人士的过渡 调查员具体而言，约翰博士将：（1）发展混合方法研究的技能，包括先进的 在定性研究方法的培训，（2）建立内容专业知识的mHealth干预艾滋病毒预防， 和（3）通过定量补充培训，获得将形成性工作转化为功效试验的专业知识 分析和实施科学。关于研究中负责任和道德行为的额外培训， 在三个主要培训目标的同时，还将注重职业提升和专业发展。 培训计划包括教学课程，独立学习，培训机构，学术会议， 手稿准备，资助写作和其他研究活动。