Phase 4
N=301
A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
HIV Prevention
Bottom Line
View on ClinicalTrials.gov: NCT01781806 ↗Enrolled (actual)
301
Serious AEs
0.7%
Results posted
Sep 2017
Primary outcome: Primary: Number of Participants With a Grade 2 or Higher Adverse Event by Cohort — 230; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- emtricitabine 200mg/tenofovir 300mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of California, Los Angeles
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Grade 2 or Higher Adverse Event by Cohort |
230; 0 | — |
| SECONDARY Cohort H PrEP Engagement by Study Visit |
246; 247; 224; 212; 194 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01781806). 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.