CCTG 594: Engagement and Retention in Care for HIV+

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byMaile Karris, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Maile Karris, MD

Principal Investigator

CCTG, UCSD AVRC, UCSD Owen Clinic

Katya Calvo, MD

Principal Investigator

CCTG, Harbor-UCLA

Eligibility Criteria

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.

See 3 more

Treatment Details

Interventions

ALERT Intervention (Behavioral Intervention)

Participant Groups

2Treatment groups

Active Control

Group I: SoC + ALERT InterventionActive Control1 Intervention

Subjects randomized into the ALERT Enhanced Retention Intervention Arm will receive SoC at the HIV clinic where subjects are seen. In addition to SoC, the Intervention arm will receive aggressive engagement efforts by the ALERT specialist to ensure visit continuity and retention into care. The ALERT specialist will also administer an education intervention consisting of 5 retention modules designed to improve HIV knowledge and self-efficacy, and will also monitor health care visits and intervene via methods to track, find, and re-engage patients during the study.

Group II: Standard of Care (SoC)Active Control1 Intervention

Subjects randomized to the Standard of Care Arm will receive their HIV clinic's current standard of care retention services.