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

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ClinicalTrials.gov Identifier: NCT01781806
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : September 20, 2017
Last Update Posted : April 6, 2018
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

Study Description
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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.

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

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : May 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cohort H (PrEP)

Participants in the H cohort will be provided with a CPP, including daily oral emtricitabine/tenofovir-based PrEP.

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. STD 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 creatinine clearance (CrCl) to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with CrCl <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 creatinine clearance (CrCl) to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with CrCl <30 mL/min, Truvada will be discontinued.
Other Name: Truvada


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With a Grade 2 or Higher Adverse Event by Cohort [ Time Frame: Baseline to 48 weeks ]
    Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.


Secondary Outcome Measures :
  1. Cohort H PrEP Engagement by Study Visit [ Time Frame: Baseline to 48 weeks ]
    Optimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days).


Other Outcome Measures:
  1. Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline [ Time Frame: Baseline to 48 weeks ]
    Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.

  2. Number of HIV Seroconversions by Cohort. [ Time Frame: Baseline to 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: February 1, 2013    Key Record Dates
Results First Posted: September 20, 2017
Last Update Posted: April 6, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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