Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 1, 2018
Open Peer Review Period: Apr 1, 2018 - Jun 7, 2018
Date Accepted: Sep 17, 2018
(closed for review but you can still tweet)
LifeSteps for Pre-exposure Prophylaxis for Young Men Who Have Sex With Men: Protocol for Adapting a Pre-exposure Prophylaxis Adherence Intervention for High-Risk Youth
ABSTRACT
Background:
New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). It is, therefore, essential that comprehensive HIV prevention strategies, specifically tailored to their needs and perceptions, are developed, tested, and disseminated. Antiretroviral pre-exposure prophylaxis (PrEP) is effective in decreasing HIV transmission among men who have sex with men; however, adherence is critical to its efficacy. In open-label studies among YMSM, adherence was suboptimal. Hence, behavioral approaches that address the unique challenges to YMSM PrEP adherence are needed.
Objective:
This study aims to describe the protocol for intervention refinement and a pilot randomized controlled trial (RCT) of a PrEP adherence intervention, LifeSteps for pre-exposure prophylaxis for young men who have sex with men (LSPY).
Methods:
This study includes the following 2 phases: formative qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement and a pilot RCT of up to 50 YMSM to assess the feasibility, acceptability, and preliminary efficacy of the LSPY, compared with the PrEP standard of care, to improve PrEP adherence. Participants will be recruited at 3 iTech subject recruitment venues in the United States.
Results:
Phase 1 is expected to begin in June 2018, and enrollment of phase 2 is anticipated to begin in early 2019.
Conclusions:
Few rigorously developed and tested interventions have been designed to increase PrEP adherence among YMSM in community settings, despite this population’s high HIV incidence. The long-term goal of this intervention is to develop scalable protocols to optimize at-risk YMSM’s PrEP uptake and adherence to decrease the HIV incidence.
Citation
Per the author's request the PDF is not available.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.