CCTG 594: Engagement and Retention in Care for HIV+

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.