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

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Drug: emtricitabine/tenofovir; Behavioral: CBT-based counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • The Fenway Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Div of Infectious Diseases, University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence	Drug: emtricitabine/tenofovir; Short-term episodic use for 2-3 weeks.; Other Names: Truvada; Behavioral: CBT-based counseling; Brief CBT-based counseling to promote adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)

Collaborators and Investigators

• Sponsor: James Egan
• Collaborators: National Institute of Mental Health (NIMH); Fenway Community Health
• Investigators: Principal Investigator: Ronald D Stall, PhD, MPH, University of Pittsburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Adherence; HIV; PrEP; MSM; Men Having Sex With Men; Episodic PrEP; Episodic HIV Risk
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine
• Other Study ID Numbers: PRO15060504; 1R34MH104083-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No