A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services (PATH-PrEP)
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| First Received Date ICMJE | January 29, 2013 | ||||||||
| Last Updated Date | April 2, 2013 | ||||||||
| Start Date ICMJE | April 2013 | ||||||||
| Estimated Primary Completion Date | April 2017 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01781806 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE |
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| Original Other Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services | ||||||||
| Official Title ICMJE | A Pilot Demonstration Project to Operationalize Pre-exposure Prophylaxis as Part of Combination HIV Prevention Among MSM and Transgender Women in Los Angeles County | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | HIV Prevention | ||||||||
| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 375 | ||||||||
| Estimated Completion Date | April 2017 | ||||||||
| Estimated Primary Completion Date | April 2017 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01781806 | ||||||||
| Other Study ID Numbers ICMJE | EI11-LA-002 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. Raphael Landovitz, University of California, Los Angeles | ||||||||
| Study Sponsor ICMJE | University of California, Los Angeles | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of California, Los Angeles | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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