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

NCT02495779 | Completed Results

• 2 other identifiers: PRO150605041R34MH104083-01A1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Human Immunodeficiency Virus

Keywords

PrEP; HIV; MSM; Men Having Sex With Men; Episodic PrEP; Adherence; Episodic HIV Risk

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Intervention

EXPERIMENTAL

Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence

Drug: emtricitabine/tenofovir; Behavioral: CBT-based counseling

Interventions

emtricitabine/tenofovir DRUG

Short-term episodic use for 2-3 weeks.

Also known as: Truvada

Intervention

CBT-based counseling BEHAVIORAL

Brief CBT-based counseling to promote adherence

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• James Egan: lead
• Fenway Community Health: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

The Fenway Institute

Boston, Massachusetts, 02215, United States

Location

Div of Infectious Diseases, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 32692109 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: James Egan
• Organization: University of Pittsburgh, Graduate School of Public Health

jee48@pitt.edu

4126242255

Study Officials

• Ronald D Stall, PhD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Kenneth Mayer, MD

  Fenway Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 13, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 27, 2019
• Results First Posted: March 27, 2019

Record last verified: 2019-03

Locations

US (2)