Feasibility of Short-Term PrEP Uptake for MSM with Episodic High-Risk for HIV
This project is supported by an R01 from the National Institute of Mental Health.
This proposed study is designed to investigate the acceptability, perceived need and uptake of episodic HIV Pre-Exposure Prophylaxis (PrEP) among men who have sex with men (MSM) who have limited risk periods. Chronic PrEP use may be unnecessary for most HIV-negative men who do not have sustained periods of high-risk sex, but may have episodic, contextually defined, high-risk periods, particularly when away from home. Alternative dosing strategies, such as short-term fixed-interval episodic PrEP (Epi-PrEP), may be a more feasible, acceptable and cost-effective option with high public health impact for the majority of high-risk MSM whose risk behaviors may be best described as episodic and non-random.
PrEP has the potential to dramatically raise the effectiveness of current HIV prevention efforts if it is correctly used. However, many questions remain about the most effective methods to promote the appropriate uptake of PrEP for the many MSM who only experience episodic periods of risk. Until we can find ways to circumvent barriers of self-identification (i.e. episodic users may not identify as “high risk”), willingness to use PrEP will be limited, impeding the promise of PrEP to prevent new HIV infections among MSM.. This proposal is designed to investigate several questions essential to the development of efficacious Epi-PrEP uptake and adherence programs. Success of this strategy, implementing short-term, fixed interval PrEP will depend on the ability of high-risk MSM to predict periods of contextually driven heightened risk, and to be adherent to Epi-PrEP regimens during these time-limited high-risk periods. In order to develop an optimized Epi-PrEP package, several questions must be addressed. This study aims to understand the prevalence and patterns of episodic risk among MSM< and to investigate how best to help MSM request and utilize Epi-PrEP during high-risk phases of their lives. The specific aims of this proposal are therefore to:
- Aim #1: Characterize and assess the prevalence of MSM who have high-risk, time limited periods when Epi-PrEP may be an optimal HIV prevention strategy, with a particular focus on low SES, racial and ethnic minority men. To accomplish this we will implement an Internet survey to high-risk MSM (N=1000) using a popular sexual networking site (oversampling ethnic minority MSM). Hypothesis: Episodic risk among MSM is relatively common, can be thematically characterized and often occurs during “time out” periods when MSM are outside of their usual social contexts (e.g. vacations, business trips). We also hypothesize that rates and themes of episodic risk periods may differ by race/ethnicity and SES, but that many MSM from each group will report periods of enhanced sexual risk.
- Aim #2: Determine the feasibility of clinic-based Epi-PrEP implementation pilot project for 50 MSM who report occasional unprotected sex and who anticipate that they will have a defined high-risk time during the study period. To accomplish this we will assess adherence to Epi-PrEP via self-report and drug level assessments for the entire period they are prescribed PrEP. Hypothesis: MSM who use Epi-PrEP will have varying levels of adherence as measured by self-report and drug levels, and those who are not adherent to Epi-PrEP will have multiple psychosocial health problems that will warrant additional adherence support.
- Aim #3: Identify specific adherence-related contexts and problems, as well as resiliencies that will inform the intervention design of a larger scale trial of the efficacy of Epi-PrEP. To do this we will conduct qualitative interviews to compare perspectives and experiences of Epi-PrEP adherent (n=10) and non-adherent (n=10) MSM from the implementation pilot (Aim 2). Hypothesis: Adherent and non-adherent men will report different themes regarding adherence vulnerabilities (e.g. substance use, lack of schedule).
This proposes a set of research activities necessary to understanding methods to help high-risk MSM access PrEP for time-limited, context-specific situations of heightened risk. believe this is first study to propose the rigorous assessment of an episodic PrEP intervention for MSM. Findings from this study will provide the empirical platform necessary to supporting the design, implementation and evaluation of the effectiveness of a short-term fixed interval episodic PrEP adherence intervention. If successful, this research agenda will provide an improved HIV prevention tool for substantial numbers of “high-risk” MSM whose risky periods are time limited, who do not need chronic PrEP.
Co-Investigator: James E Egan