Clinical trial NCT02495779: Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV
Official title: Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: PrEP
HIV
MSM
Men Having Sex With Men
Episodic PrEP
Adherence
Episodic HIV Risk
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Fenway Community Health
name: National Institute of Mental Health (NIMH)
First posted: 2015-07-13
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With PrEP Adherence
timeFrame: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: The Fenway Institute
state: Massachusetts
city: Pittsburgh
country: United States
facility: Div of Infectious Diseases, University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ronald D Stall, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Fenway Health
name: Kenneth Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Egan JE, Ho K, Stall R, Drucker MT, Tappin R, Hendrix CW, Marzinke MA, Safren SA, Mimiaga MJ, Psaros C, Elsesser S, Mayer KH. Feasibility of Short-Term PrEP Uptake for Men Who Have Sex With Men With Episodic Periods of Increased HIV Risk. J Acquir Immune Defic Syndr. 2020 Aug 15;84(5):508-513. doi: 10.1097/QAI.0000000000002382.