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

James Egan54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Human Immunodeficiency Virus

Interventions

emtricitabine/tenofovirDRUG

Short-term episodic use for 2-3 weeks.

CBT-based counselingBEHAVIORAL

Brief CBT-based counseling to promote adherence

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

The Fenway Institute

Boston, Massachusetts, United States

Div of Infectious Diseases, University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Number of Participants With PrEP Adherence

Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL.

Time frame: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)

Data from ClinicalTrials.gov

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