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: 10796690
• 负责人: Steven A John
• 金额: $ 4.67万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10796690
• 关键词: AIDS prevention; Adherence; Administrative Supplement; Affect; Age; Attitude; Award; Behavioral; Black race; Budgets; COVID-19 impact; COVID-19 pandemic; Caring; Clinic; Clinical; Clinical Trials; Counseling; Data; Data Analyses; Development; Devices; Economics; Enrollment; Equilibrium; Ethics; Extramural Activities; Face; Failure; Focus Groups; Friends; Funding; Goals; Grant; HIV; HIV Infections; HIV Seropositivity; Human Resources; Human immunodeficiency virus test; Incidence; Individual; Infection; Insurance; Intervention; Interview; Latinx; Lesbian Gay Bisexual Transgender; Liquid substance; Mentors; Methods; Modeling; Motivation; National Institute of Mental Health; Oklahoma; Oral; Outcome; Outsourcing; Parents; Participant; Patient Recruitments; Population; Pre-Post Tests; Prevention; Provider; Public Health; Randomized; Randomized, Controlled Trials; Reporting; Request for Applications; Research; Research Activity; Research Methodology; Risk; Risk Reduction; Route; Scientific Advances and Accomplishments; Self Administration; Self Efficacy; Surveys; Testing; Training; Translating; Treatment Efficacy; United States Food and Drug Administration; United States National Institutes of Health; Wages; Work; Youth; barrier to testing; career; career development; condoms; coping; cost; efficacy trial; ethnic disparity; exhaust; falls; follow up assessment; follow-up; improved; mHealth; pandemic disease; parent grant; pill; pilot trial; pre-exposure prophylaxis; racial disparity; recruit; remediation; self testing; sexual minority men; skills; social stigma; success; therapy development; timeline; transmission process; uptake; young men who have sex with men

PROJECT SUMMARY / ABSTRACT This application requests an administrative supplement under NOT-MH-21-120, “Administrative Supplements for COVID-19 Impacted NIMH Research.” The requested supplement is to K01-MH118939, “Optimizing an IMB-guided intervention to support HIV self-testing and PrEP uptake among YMSM: A pilot factorial RCT.” The parent grant is funded until August 31, 2023. The PI has suffered significant setbacks in the proposed research caused by the COVID-19 pandemic and exhausted all other means to help the project’s success. The impact of these setbacks resulted in the grant falling 24 months behind the initial timeline of research activities; the pandemic hit 7 months into the funded project. To help mitigate these effects, the PI outsourced participant recruitment, hired mHealth technical support, and funded additional personnel support; these remediation activities exhausted all funds available via rebudgeting and using remaining start-up (internal) funding. Despite these setbacks, the project is on track to complete clinical trial launch and baseline enrollment by the end of the funded project period. This supplement requests an additional 5-months salary support for the PI to complete the final Aim of the project. The requested funds will help support the PI collecting outcome data and conducting endpoint data analysis. This funding is essential to fulfill the research objectives of the parent award given the substantial risks to completion of the randomized controlled trial due to delays and impact caused by the COVID-19 pandemic. Failure to complete the clinical trial would reduce scientific advancements of the study and limit the PI’s ability to successfully compete for R01 funding in this line of research. The PI is in the final year of the K01 without additional extramural funding to continue this research trajectory; the PI’s recently awarded R34 has only 15% salary support and is a different line of research focused on increasing expedited partner therapy and pre-exposure prophylaxis (PrEP) prescribing practices among providers in Oklahoma. As such, the requested supplement will be instrumental to help the PI finish the proposed research and support his final training component related to translating pilot trial findings into an R01 application. The final research Aim of his project is to assess the feasibility, acceptability, and preliminary impact of an mHealth intervention for young sexual minority men to increase HIV self-testing and PrEP uptake and adherence. This supplement does not propose to extend the funded project period; however, we anticipate a no cost extension at conclusion of the active funding period. The estimated unobligated balance of the grant will be spent before the end of the project period or carried over to a no cost extension; the remaining funds for carry over are budgeted for remaining research expenses and dissemination. During the no cost extension, the PI will conduct follow-up assessments with participants, analyze and disseminate data, and prepare an R01 application based on feasibility, acceptability, and preliminary impact findings.

项目总结/摘要 本申请要求根据NOT-MH-21-120“行政补充” COVID-19影响NIMH研究的补充。要求的补充是K 01-MH 118939， “优化IMB指导的干预措施，以支持YMSM中的艾滋病毒自我检测和PrEP摄取：试点 factorial RCT。”父母补助金的资助期限为2023年8月31日。PI在这方面遭受了重大挫折， 2019冠状病毒病大流行引起的拟议研究，并用尽了所有其他手段，以帮助该项目的 成功这些挫折的影响导致赠款比最初的时间轴晚了24个月。 研究活动;大流行病进入资助项目7个月。为了帮助减轻这些影响，PI 外包参与者招募，雇用mHealth技术支持，并资助额外的人员支持; 这些补救活动耗尽了通过重新预算和使用剩余启动资金可获得的所有资金 （内部）融资。尽管遇到了这些挫折，该项目仍有望完成临床试验启动和基线 在项目资助期结束前报名。这一补充要求增加5个月的工资 支持PI完成项目的最终目标。所要求的资金将有助于支持PI 收集结果数据并进行终点数据分析。这笔资金对完成这项研究至关重要 鉴于完成随机对照试验的重大风险， COVID-19疫情造成的延误和影响。如果不能完成临床试验， 研究的科学进步，并限制了PI成功竞争R 01资金的能力， 研究路线。PI处于K 01的最后一年，没有额外的校外资金来继续这项工作 研究轨迹; PI最近授予的R34只有15%的工资支持，是一个不同的路线， 研究重点是增加快速伴侣治疗和暴露前预防（PrEP）处方 在俄克拉荷马州的供应商之间的做法。因此，所要求的补充将有助于PI 完成拟议的研究，并支持与翻译试点试验结果有关的最后培训部分 R 01应用程序。他的项目的最终研究目的是评估可行性，可接受性， 移动健康干预措施对年轻性少数男性的初步影响，以增加艾滋病毒自我检测， PrEP摄取和依从性。本补编并不打算延长供资项目的期限;但是， 我们预计在有效供资期结束时将无费用延长。估计未支配 余下的资助金会在计划期完结前用罄，或转拨至无成本的延长期; 剩余的结转资金用于剩余的研究费用和传播。期间 如果没有费用，PI将与参与者进行后续评估，分析和传播 数据，并根据可行性、可接受性和初步影响调查结果准备R 01申请。