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.

项目摘要 /摘要 该申请要求根据非MH-21-120的管理补充 COVID-19的补品影响了NIMH研究。 “优化IMB引导的干预措施，以支持YMSM中的艾滋病毒自我测试和准备吸收：飞行员 阶乘RCT。“父母赠款的资助至2023年8月31日。PI在 拟议的研究是由Covid-19引起的，并用尽了所有其他手段，以帮助该项目 成功。这些挫折的影响导致赠款落后于最初时间表的24个月 研究活动；大流行进入了资助项目7个月。为了减轻这些影响，PI 外包参与者招聘，雇用了MHealth的技术支持并资助了其他人员支持； 这些补救活动耗尽了所有通过辩护和使用剩余的启动可用的资金 （内部）资金。尽管有这些挫折，但该项目仍在进行完整的临床试验发布和基线 在资助项目期结束时注册。此补充要求额外的5个月薪水 支持PI完成项目的最终目标。要求的资金将有助于支持PI 收集结果数据并进行端点数据分析。这笔资金对于完成研究至关重要 父母裁决的目标鉴于完成随机对照试验的重大风险 延迟和影响是由19009年大流行引起的。未能完成临床试验将减少 研究的科学进步，并限制了PI成功竞争R01资金的能力 研究线。 PI在K01的最后一年，没有额外的壁外资金来继续此 研究轨迹； PI最近授予的R34只有15％的薪水支持，并且是不同的行 研究重点是增加加急的伴侣治疗和暴露前预防（PREP）开处方 俄克拉荷马州提供者的实践。因此，要求的补充剂将有助于帮助PI 完成拟议的研究并支持与翻译试验试验结果有关的最终培训组成部分 进入R01应用程序。他项目的最终研究目的是评估可行性，可接受性和 MHealth干预对年轻性少数群体的初步影响，以增加艾滋病毒自我测试和 准备吸收和依从性。该补充不建议延长资助的项目期限；然而， 我们预计在积极的融资期结束时，我们预计会有无需延长的成本。估计的未经限制 赠款的余额将在项目期结束之前花费，或者将其延长至无需延长； 剩余的携带资金是预算用于剩余的研究费用和传播的预算。期间 无费用延长，PI将对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结果准备R01应用程序。