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

Medical College Of Wisconsin, Milwaukee WI

Investigators

Linked publications & trials

Abstract

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.