A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services

HIV Prevention Clinical Trial

— PATH-PrEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781806
• Other study ID #: EI11-LA-002
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2013
• Last updated: April 4, 2018
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: April 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Prevention

Intervention

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.

Locations

Country	Name	City	State
United States	L.A. Gay and Lesbian Center	Los Angeles	California
United States	The OASIS Clinic	Los Angeles	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Los Angeles	AIDS Project Los Angeles, Los Angeles County Department of Public Health, Los Angeles LGBT Center, The OASIS Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline	Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.	Baseline to 48 weeks
Other	Number of HIV Seroconversions by Cohort.		Baseline to 48 weeks
Primary	Number of Participants With a Grade 2 or Higher Adverse Event by Cohort	Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.	Baseline to 48 weeks
Secondary	Cohort H PrEP Engagement by Study Visit	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