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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495779
• Other study ID #: PRO15060504
• Secondary ID: 1R34MH104083-01A
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: November 2017

Study information

• Verified date: March 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• emtricitabine/tenofovir
Short-term episodic use for 2-3 weeks.

Behavioral:
• CBT-based counseling
Brief CBT-based counseling to promote adherence

Locations

Country	Name	City	State
United States	The Fenway Institute	Boston	Massachusetts
United States	Div of Infectious Diseases, University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
James Egan	Fenway Community Health, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)