NCT02495779

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: James Egan · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	emtricitabine/tenofovir	Short-term episodic use for 2-3 weeks.
BEHAVIORAL	CBT-based counseling	Brief CBT-based counseling to promote adherence

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2015-07-13
• Last updated: 2019-03-27
• Results posted: 2019-03-27

Locations

2 sites across 1 country: United States