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

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
emtricitabine/tenofovir
CBT-based counseling
Sponsored by
James Egan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring PrEP, HIV, MSM, Men Having Sex With Men, Episodic PrEP, Adherence, Episodic HIV Risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • The Fenway Institute
  • Div of Infectious Diseases, University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2015
Last Updated
March 26, 2019
Sponsor
James Egan
Collaborators
Fenway Community Health, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02495779
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James Egan
Collaborators
Fenway Community Health, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
PrEP, HIV, MSM, Men Having Sex With Men, Episodic PrEP, Adherence, Episodic HIV Risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence
Intervention Type
Drug
Intervention Name(s)
emtricitabine/tenofovir
Other Intervention Name(s)
Truvada
Intervention Description
Short-term episodic use for 2-3 weeks.
Intervention Type
Behavioral
Intervention Name(s)
CBT-based counseling
Intervention Description
Brief CBT-based counseling to promote adherence
Primary Outcome Measure Information:
Title
Number of Participants With PrEP Adherence
Description
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.
Time Frame
Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald D Stall, PhD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Mayer, MD
Organizational Affiliation
Fenway Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fenway Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Div of Infectious Diseases, University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32692109
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.
Results Reference
derived

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

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