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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
117
Enhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care.
University Southern California
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
Time to lost to follow up
The CCTG 594 primary outcome is "time to lost to follow up." Lost to follow up is defined as "no visit with a prescribing HIV provider in the last 180 days. All randomized subjects will be followed for a minimum of 48 weeks. Subjects that do not meet the primary endpoint by the time the study ends will be censored.
Time frame: Baseline to Week 48
Time to initiation of ART
The CCTG 594 secondary outcome is "time to initiation of ART." All randomized subjects will be followed for a minimum of 48 weeks. Subjects that do not initiate ART will be censored at their last visit date.
Time frame: Baseline to Week 48
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