A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborators: AIDS Project Los Angeles; Los Angeles County Department of Public Health; Los Angeles LGBT Center; The OASIS Clinic
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

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.