NCT01957748

CCTG 594: Engagement and Retention in Care for HIV+

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Patient Adherence
• HIV Positive

Interventions

Type	Name	Description
BEHAVIORAL	SoC + ALERT Intervention	Enhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care.

Timeline

• Start date: 2013-10-08
• Primary completion: 2017-12-15
• Completion: 2020-11-24
• First posted: 2013-10-08
• Last updated: 2021-12-09

Locations

3 sites across 1 country: United States