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

James Egan

Status

Completed

Conditions

Human Immunodeficiency Virus

Treatments

Behavioral: CBT-based counseling

Drug: emtricitabine/tenofovir

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02495779

1R34MH104083-01A1 (U.S. NIH Grant/Contract)

PRO15060504

Details and patient eligibility

About

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.

Full description

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.

Enrollment

54 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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