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

项目摘要/摘要 此应用程序请求在NOT-MH-21-120下的管理补充 新冠肺炎的补充剂影响了NIMH研究。“所要求的补充是K01-MH118939， 优化IMB引导的干预措施，以支持青年男性接触者中的HIV自我检测和PrEP吸收：一项试点 阶乘RCT。家长助学金的资助期限至2023年8月31日。在过去的几年里，和平协会遭受了重大挫折 新冠肺炎大流行引发的拟议研究，并用尽了所有其他手段来帮助该项目 成功。这些挫折的影响导致赠款比最初的时间表推迟了24个月 研究活动；大流行袭击了资助项目的7个月。为了帮助缓解这些影响，PI 外包参与者招聘，雇用mHealth技术支持，并为额外的人员支持提供资金； 这些补救活动耗尽了通过重新编制预算和使用剩余启动项目提供的所有资金 (内部)资金。尽管有这些挫折，该项目仍有望完成临床试验启动和基线 在资助项目期结束前招生。这项补充要求额外支付5个月的工资。 支持PI完成项目的最终目标。申请的资金将帮助支持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是必不可少的 考虑到完成到期随机对照试验的重大风险，父母奖的目标 新冠肺炎大流行造成的延误和影响。未能完成临床试验将减少 研究的科学进展和限制了PI在这方面成功竞争R01资金的能力 研究领域。PI是K01的最后一年，没有额外的外部资金来继续这一点 研究轨迹；PI最近获得的R34只有15%的工资支持，是一条不同的路线 研究重点是增加快速伴侣治疗和暴露前预防(PrEP)处方 俄克拉荷马州供应商的做法。因此，所要求的补充将有助于帮助PI 完成拟议的研究，并支持与翻译飞行员试验结果相关的最终培训部分 到R01应用程序中。他的项目的最终研究目标是评估可行性、可接受性和 对年轻的性少数族裔男性进行mHealth干预以增加HIV自我检测和 准备吸收和坚持。本补编不建议延长已获资助的项目期；但是， 我们预计，在积极的资金期结束时，不会有成本延长。估计的未付债务 赠款的余额将在项目期结束前使用，或结转到无成本延期； 结转的剩余资金预算用于剩余的研究费用和传播。在.期间 免费延期，PI将与参与者进行跟踪评估，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申请。

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.