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A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services (PATH-PrEP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Los Angeles County Department of Public Health
Los Angeles LGBT Center
The OASIS Clinic
AIDS Project Los Angeles
Information provided by (Responsible Party):
Dr. Raphael Landovitz, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01781806
First received: January 29, 2013
Last updated: September 13, 2015
Last verified: September 2015
History of Changes
  Purpose
The purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of PrEP or PEP as part of combination HIV prevention services for high-risk MSM and transgender women.

Condition Intervention Phase
HIV Prevention
 Drug: emtricitabine 200mg/tenofovir 300mg
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Demonstration Project to Operationalize Pre-exposure Prophylaxis as Part of Combination HIV Prevention Among MSM and Transgender Women in Los Angeles County

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Safety: Adverse events/Serious Adverse Events [ Time Frame: Baseline to 48 weeks ] [ Designated as safety issue: Yes ]
    Number and frequency rate of clinical and laboratory AEs (Gr 2 and above) and SAEs


Secondary Outcome Measures:
  • Adherence to daily FTC/Tenofovir [ Time Frame: Baseline to 48 weeks ] [ Designated as safety issue: Yes ]
    Daily FTC/Tenofovir adherence, as measured by self-report, medication possession ratio (MPR), and levels of FTC-TP and/or TFV-DP in serum (detectable or undetectable) and erythrocytes via dried blood spots.


Other Outcome Measures:
  • Change in transmission-risk behavior [ Time Frame: Baseline to 48 weeks ] [ Designated as safety issue: Yes ]
    Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.

  • Cost per participant [ Time Frame: Baseline to 48 weeks ] [ Designated as safety issue: No ]
    Estimate the per-participant costs for the CPP model, providing a benchmark for comparison with other cities' PrEP demonstration projects, and to allow modeling of cost-efficacy scenarios.

  • HIV Seroconversion and treatment-emergent resistance [ Time Frame: Baseline to 48 weeks ] [ Designated as safety issue: Yes ]
    Number and rate of HIV seroconversions, and treatment emergent resistance mutations, viral set point, and subsequent response to ART-treatment
Estimated Enrollment: 375
Study Start Date: May 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort H (PrEP)

Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).

High Risk Cohort Criteria (one or more of the following has to be met):

  1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
  2. STI diagnosis during the last 12 months.
  3. Previous PEP use during the last 12 months (* see exclusion criteria)
  4. Has at least one HIV infected sexual partner for ≥4 weeks.
 Drug: emtricitabine 200mg/tenofovir 300mg
The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued.
Other Name: Truvada
Active Comparator: Cohort LM (PEP)
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
 Drug: emtricitabine 200mg/tenofovir 300mg
The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued.
Other Name: Truvada

Detailed Description:

Two community-based sites (Los Angeles Gay and Lesbian Center [LAGLC] 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, 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 post-exposure prophylaxis (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. STI testing will be performed at 3 month intervals. An escalating-intensity adherence intervention will be implemented based on real-time serum tenofovir levels. A computer-assisted self-interview (CASI) will be used to capture detailed sexual risk, adherence, and substance use behavior.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 Transgender (MTF)
  • At least one male sex partner for anal intercourse in the prior 12 months
  • HIV negative by EIA and VL
  • Creatinine clearance ≥ 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781806

Locations
United States, California
L.A. Gay and Lesbian Center
Los Angeles, California, United States, 90028
The OASIS Clinic
Los Angeles, California, United States, 90059
Sponsors and Collaborators
University of California, Los Angeles
Los Angeles County Department of Public Health
Los Angeles LGBT Center
The OASIS Clinic
AIDS Project Los Angeles
Investigators
Principal Investigator: Raphael Landovitz, MD University of California, Los Angeles
  More Information

Responsible Party: Dr. Raphael Landovitz, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01781806     History of Changes
Other Study ID Numbers: EI11-LA-002 
Study First Received: January 29, 2013
Last Updated: September 13, 2015
Health Authority: United States: Institutional Review Boards: UCLA, UCLA (for LAGLC), Charles Drew University (for OASIS)

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 29, 2016