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Status
Planned
Phase
Open Label
Principal Investigator(s)
Ronald D Stall, PhD, MPH
Objective
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.
Eligibility
Prevention Option(s)
PrEP
Study Design
Open label
Arms and Assigned Interventions
Description
Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence
Products
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
July 2015
December 2017
Enrollment
50
18
Years
Sites
Fenway Institute
Boston, Massachusetts
United States of America
University of Pittsburgh CRS
Pittsburgh, Pennsylvania
United States of America