Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV

This proposed study is designed to investigate the acceptability, perceived need and uptake
of short-term episodic Pre-Exposure Prophylaxis for HIV prevention among men who have sex
with men (MSM). Long-term PrEP may be unnecessary for the many HIV-uninfected men who have
episodic contextually defined high-risk periods, particularly when away from their home
setting. Alternative dosing strategies, such as short-term fixed-interval episodic PrEP
(Epi-PrEP), may be a more realistic, feasible, acceptable, and useful option with high public
health impact for the majority of MSM. The overall objective is to determine the feasibility
of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study
sites) who report occasional condomless sex and who anticipate a period of high-risk while
away from home (e.g. vacation) during the study period.

Inclusion Criteria:

- Self-identify as MSM: (1) born male who (2) has sex with men

- Age: 18 or older

- Sexual Risk: has had condomless anal sex with 2 or more men or any transactional sex
with a man within the past 12-months.

- Vacation: identified an upcoming period of episodic risk away (i.e. vacation) from
their home city that will last at least 7 but not more than 14 days during which they
anticipate having at least one high-risk sexual event.

- Able and willing to provide informed consent

Exclusion Criteria:

- HIV positive

- Glomerular filtration rate < 60 mL/min (calculated using the Cockcroft-Gault formula)

- Hepatitis B surface antigen positive

- Symptoms suggestive of acute HIV seroconversion at screening or enrollment

- Have used PrEP or PEP within the previous 3 months

- Currently enrolled in another study involving medications, investigational drug, or
medical device

- Has other conditions (based on opinion of investigator or designee) that would
preclude informed consent, make the study unsafe, complicate interpretation of study
outcome data, or otherwise interfere with study procedures