A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services (PATH-PrEP)
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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 |
- 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
- 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.
- 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: | April 2013 |
Estimated Study Completion Date: | April 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):
|
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.
![](https://webarchive.library.unt.edu/web/20130317075523im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
- Signs or symptoms suspicious for PHI.
![](https://webarchive.library.unt.edu/web/20130317075523im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: Raphael J Landovitz, MD MSc | 3105571891 | rlandovitz@mednet.ucla.edu |
Contact: Anna Tsivina | 3105573410 | atsivina@mednet.ucla.edu |
United States, California | |
L.A. Gay and Lesbian Center | Not yet recruiting |
Los Angeles, California, United States, 90028 | |
Contact: Risa Flynn 323-993-7500 rflynn@lagaycenter.org | |
Principal Investigator: Robert Bolan, MD | |
The OASIS Clinic | Not yet recruiting |
Los Angeles, California, United States, 90059 | |
Contact: Vincent Ofori 310-557-1891 vofori@mednet.ucla.edu | |
Principal Investigator: Wilbert Jordan, MD |
Principal Investigator: | Raphael Landovitz, MD | University of California, Los Angeles |
![](https://webarchive.library.unt.edu/web/20130317075523im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
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: | February 26, 2013 |
Health Authority: | United States: Institutional Review Boards: UCLA, UCLA (for LAGLC), Charles Drew University (for OASIS) |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir |
Tenofovir disoproxil Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on March 14, 2013