A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
Completed · Phase 4
Conditions studied: HIV Prevention
In brief
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.
Key facts
- Study ID
- NCT01781806
- Run by
- University of California, Los Angeles
- People needed
- 328
- Starts
- 2013-05-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2018-04-06
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- L.A. Gay and Lesbian Center — Los Angeles, California, United States
- The OASIS Clinic — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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