- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01781806
A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services (PATH-PrEP)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90028
- L.A. Gay and Lesbian Center
-
Los Angeles, California, United States, 90059
- The OASIS Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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):
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline to 48 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 48 weeks
|
Number of HIV Seroconversions by Cohort.
Time Frame: Baseline to 48 weeks
|
Baseline to 48 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Raphael Landovitz, MD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EI11-LA-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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