N/A
N=54
Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT02495779 ↗Enrolled (actual)
54
Serious AEs
2.1%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants With PrEP Adherence — 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- emtricitabine/tenofovir (Drug); CBT-based counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- James Egan
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With PrEP Adherence |
45 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02495779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.