Clinical trial NCT01781806: A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
Official title: A Pilot Demonstration Project to Operationalize Pre-exposure Prophylaxis as Part of Combination HIV Prevention Among Men Who Have Sex With Men (MSM) and Transgender Women in Los Angeles County
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Prevention
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Los Angeles County Department of Public Health
name: Los Angeles LGBT Center
name: The OASIS Clinic
name: AIDS Project Los Angeles
First posted: 2013-02-01
Enrollment: 328
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Two community-based sites (LALGBT Center and The OASIS Clinic) will serve as facilities at which participants may present for screening for prevention services. At the sites, eligibility criteria will be assessed, HIV, Sexually Transmitted Disease (STD) and laboratory testing will be performed, and HIV prevention service referrals will be initiated. Follow-up will be on a monthly basis for the first three months, and then de-escalated to an every-3-month interval.

The program stratifies participants into two cohorts on the basis of sexual risk behavior: a low-moderate risk cohort (LM) and a high-risk cohort (H). Participants in the LM cohort will be provided a customized prevention package (CPP) including access to PEP for emergency HIV prevention in the event of unanticipated HIV exposure. Participants in the H cohort will be provided a CPP including daily Truvada-based PrEP. All participants will be followed for 48 weeks. Participants in the LM cohort who, on longitudinal sexual risk behavior surveillance, report increased levels of sexual risk-taking such that they meet enrollment criteria for the H-cohort will be transitioned to the H-cohort.

At each follow-up visit, a careful safety assessment will be made, including signs/symptoms and laboratory assessments. STD testing will be performed at 3 month intervals. An escalating-intensity adherence intervention will be implemented based on real-time plasma tenofovir levels. A computer-assisted self-interview (CASI) will be used to capture detailed sexual risk, adherence, and substance use behavior.

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.

Primary outcomes:
measure: Number of Participants With a Grade 2 or Higher Adverse Event by Cohort
timeFrame: Baseline to 48 weeks
Secondary outcomes:
measure: Cohort H PrEP Engagement by Study Visit
timeFrame: Baseline to 48 weeks
Other outcomes:
measure: Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline
timeFrame: Baseline to 48 weeks
measure: Number of HIV Seroconversions by Cohort.
timeFrame: Baseline to 48 weeks
Locations:
city: Los Angeles
country: United States
facility: L.A. Gay and Lesbian Center
state: California
city: Los Angeles
country: United States
facility: The OASIS Clinic
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Raphael Landovitz, MD
role: PRINCIPAL_INVESTIGATOR
References: