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

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex with men (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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: James Egan; Ronald Stall
• Collaborators: Fenway Community Health; National Institute of Mental Health (NIMH)
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

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