Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV

A Pilot Project to Operationalize the Prevention Strategy of Post Exposure Prophylaxis Following Sexual Exposure to HIV in Combination With Educational Programming and Behavioral Risk Reduction Strategies in Los Angeles County

The purpose of this program is to evaluate an effort to provide a comprehensive package of HIV prevention services of which post-exposure prophylaxis (medicines that may help prevent HIV infection after an exposure) can be a part. It will also include risk reduction information and testing for other sexually transmitted infections.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV Prevention
• Intervention / Treatment: Drug: tenofovir + emtricitabine, lopinavir/ritonavir

Detailed Description

The Los Angeles County P-QUAD program is a combined effort of County, City, public health, community, academic, and private agencies and individuals in an effort to provide a comprehensive package of HIV prevention services of which PEP can be an integral component. These services are designed to be easily accessible, non-judgmental, culturally, ethnically, and linguistically appropriate to the relevant populations, community-based, and independent of ability to pay or insurance/documentation status. They will also provide vital linkages to associated services, routine HIV testing, and primary health care.

In its initial pilot project, 2 community-based sites will serve as facilities at which patients may present for screening for post-exposure prophylaxis services, as well as sexually transmitted diseases. At the sites, initial eligibility and testing will be performed, and an initial 14-day supply of PEP medications will be provided if appropriate, and referrals will be initiated. All subjects who are provided an initial 14-day supply will be required to return to the site for the remainder of the 28-day course of medication, follow-up testing, adherence counseling, risk-reduction programming, and other appropriate referrals. Follow-up with patients by phone, email, and mobile-phone text message will be used as appropriate to maximize program retention.

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90059
      • OASIS Clinic
    • Los Angeles, California, United States, 90028
      • L.A. Gay & Lesbian Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must be at least 18 years of age
• Able to understand and provide consent
• High-Risk Exposure Characteristic

• (one or more of the below, unprotected or with failed condom use)

  • Receptive Anal Intercourse
  • Insertive Anal Intercourse
  • Receptive Vaginal Intercourse
  • Insertive Vaginal Intercourse

• Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source (supersedes all "high-risk source" criteria below)

  • Sharing injection drug works which have been intravascular

• High-Risk Source (one or more of the below)

  • Known HIV positive
  • MSM
  • MSM/W
  • IDU
  • CSW
  • Sexual perpetrator
  • From an endemic country (prevalence >1%)
  • Partner of one of the above
• Exposure within 72 hours of presentation
• Not known to be HIV positive
• No countermanding concomitant medications or allergies
• HIV-negative on presentation and without symptoms of PHI (do not withhold first dose pending these laboratory assessments).

Exclusion Criteria:

• Patients <18 years of age
• Unable to understand and provide consent
• Exposure >72 hours of presentation
• Known to be HIV positive
• Currently in-progress of a course of PEP initiated via non-P-QUAD mechanisms

• Any condition, which in the opinion of the intake provider, will seriously compromise the patient's ability to comply with the protocol, including

  • adherence to PEP medication dosing
  • Demonstrated HIV-positive on rapid testing
  • Unwillingness to commit to barrier-method (male and/or female condom) use until HIV-negative-status is confirmed 6 months after exposure
  • Unwillingness of breast-feeding women to transition to formula feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Open-Label; This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP.

Drug: tenofovir + emtricitabine, lopinavir/ritonavir; The preferred regimen 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 creatinine clearance 30-49 mL/min, dosing of Truvada is 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min or on hemodialysis, Truvada should not be used. For intolerance to Truvada, Combivir (zidovudine 300mg/lamivudine 150mg)will be available to be taken as 1 PO BID. For highest-risk category exposures (receptive anal intercourse with a known or suspected HIV-positive source patient or in cases of suspected source drug resistance, see Schema, below) one of the following should be added to the above "standard" treatment, creating an "expanded" regimen: Preferred: Lopinavir/ritonavir (200mg/50mg), 2 tablets orally twice daily or 4 tablets once daily; Other Names: Truvada; Combivir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit	24 Weeks

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Los Angeles County Department of Public Health; Los Angeles LGBT Center; The OASIS Clinic; AIDS Project Los Angeles
• Investigators: Principal Investigator: Raphael J. Landovitz, M.D., University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: July 29, 2009
• First Submitted That Met QC Criteria: July 29, 2009
• First Posted (ESTIMATE): July 30, 2009

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: HIV seronegativity; post exposure prophylaxis; biomedical prevention
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Tenofovir; Emtricitabine; Ritonavir; Lopinavir
• Other Study ID Numbers: PQUAD