Abstract
BackgroundNew 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.ObjectiveThis 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).MethodsThis 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.ResultsPhase 1 is expected to begin in June 2018, and enrollment of phase 2 is anticipated to begin in early 2019.ConclusionsFew 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.International Registered Report Identifier (IRRID)DERR1-10.2196/10661
Highlights
BackgroundIn the United States, men who have sex with men (MSM) represent over half of all individuals living with HIV (56%) [1,2] and account for the largest number of new HIV infections each year (70%), with rates of new diagnoses at least 44 times higher than rates among heterosexual men [1,2]
Pharmacological analyses corroborated the highly protective effects of TDF/FTC for pre-exposure prophylaxis (PrEP) among individuals who had detectable medication levels in their blood, highlighting the critical role of adherence in PrEP efficacy. This underscores the need for future PrEP interventions to focus on evidence-based strategies to promote adherence, to optimize the benefits that antiretroviral chemoprophylaxis may be able to provide for at-risk MSM
This paper aims to describe the protocol for the refinement of LifeSteps for PrEP for young men who have sex with men (YMSM) (LSPY) and a pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of LSPY
Summary
BackgroundIn the United States, men who have sex with men (MSM) represent over half of all individuals living with HIV (56%) [1,2] and account for the largest number of new HIV infections each year (70%), with rates of new diagnoses at least 44 times higher than rates among heterosexual men [1,2]. Pharmacological analyses corroborated the highly protective effects of TDF/FTC for PrEP among individuals who had detectable medication levels in their blood, highlighting the critical role of adherence in PrEP efficacy. This underscores the need for future PrEP interventions to focus on evidence-based strategies to promote adherence, to optimize the benefits that antiretroviral chemoprophylaxis may be able to provide for at-risk MSM. New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM) It is, essential that comprehensive HIV prevention strategies, tailored to their needs and perceptions, are developed, tested, and disseminated.
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