A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Se… (NCT01781806) | Clinical Trial Compass
CompletedPhase 4
A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
United States328 participantsStarted 2013-05
Plain-language summary
The purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of combination HIV prevention services for high-risk MSM and transgender women.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* At least 18 years of age
* Able to understand and provide consent in English or Spanish
* Self identified MSM, MSM/W, or Transfemale
* At least one male sex partner for anal intercourse in the prior 12 months
* HIV negative by enzyme immunoassay (EIA) and viral load (VL)
* CrCl ≥ 60 ml/min (via Cockcroft-Gault formula)
* No signs or symptoms suggestive of primary HIV infection (PHI).
Exclusion Criteria:
* Participants \<18 years of age
* Unable to understand and provide consent in English or Spanish
* Known or found on testing to be HIV positive
* Any condition, which in the opinion of the intake provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PEP or PrEP medication dosing
* Use of Antiretroviral therapy (ART) taken for any indication (i.e. PEP or PrEP) within 60 days of study entry
* Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
* Signs or symptoms suspicious for PHI.
What they're measuring
1
Number of Participants With a Grade 2 or Higher Adverse Event by Cohort