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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Fenway Institute, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emtricitabine/tenofovir

Drug

Short-term episodic use for 2-3 weeks.

Other names: Truvada

CBT-based counseling

Behavioral

Brief CBT-based counseling to promote adherence

Primary outcomes

Number of Participants With PrEP Adherence

Time frame: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)

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.

Sponsors and collaborators

Lead sponsor

James Egan

Other

Collaborators

Fenway Community Health
National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Jul 13, 2015
Registry last updated: Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed