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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: emtricitabine/tenofovir
* Behavioral: CBT-based counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, HIV, MSM, Men Having Sex With Men, Episodic PrEP, Adherence, Episodic HIV Risk