Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Amy Sitapati

Description

Summary

CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics.

Official Title

CCTG 594: Engagement and Retention in Care for HIV+, A Multicenter Trial of the California Collaborative Treatment Group

Details

Design: CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics.

Duration: Each subject will receive follow-up of at least 48 weeks.

Sample Size: A total of 300 subjects will be randomized, 150 per arm.

Study Population: Eligible subjects will include 1) newly diagnosed HIV-infected individuals entering primary HIV care at one of the CCTG clinics, or 2) previously diagnosed HIV-infected individuals who are "out of care" defined as having no visit with a prescribing HIV provider in the last 180 days and not on a stable ARV regimen.

Stratification: Subjects will be stratified based on study site and if they are newly diagnosed or returning to care.

Keywords

Patient Adherence HIV Positive Retention Care Engagement HIV Seropositivity SoC + ALERT Intervention

Eligibility

You can join if…

Open to people ages 18 years and up

  • HIV-1 infection, as documented by any licensed screening antibody test, such as ELISA,and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western blot is not available, HIV infection may be documented by two HIV RNA values ≥2000 copies/mL,drawn at least 24 hours apart. The RNA assays must have been run at a CLIA-approved laboratory or equivalent.
  • 18 years of age or older.
  • Able to give written informed consent.
  • New patient to the clinic (defined as someone who has never engaged in HIV care) or a patient returning to care (defined as a patient previously seen at least once by a prescribing HIV provider who has not seen a prescribing HIV provider in the last 180 days and is not on a stable ARV regimen).
  • English or Spanish Speaking.
  • Registered to receive HIV primary care services at one of the identified CCTG-affiliated clinic, i.e. the Owen Clinic at UC San Diego Health System,Harbor-UCLA Medical Center clinic or Rand Schrader clinic at USC.

You CAN'T join if...

  • Unstable neurologic, psychiatric, or physical condition which, in the opinion of the investigator, would limit participation with study procedures for the duration of the study.
  • A level of drug or alcohol use that, in the opinion of the investigator, would preclude safe participation in the study.
  • Resident of nursing home or skilled facility.
  • Pregnant or breastfeeding.
  • Patient's first primary care visit (for new patients) or return to care visit (for patients returning to care) occurred > 60 days ago.

Locations

  • University of California, San Diego
    San Diego California 92103 United States
  • Harbor-UCLA Medical Center
    Torrance California 90502 United States
  • University Southern California
    Los Angeles California 90033 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
California Collaborative Treatment Group
ID
NCT01957748
Lead Scientist
Amy Sitapati
Study Type
Interventional
Last Updated
February 2017