CCTG 594: Engagement and Retention in Care for HIV+
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||CCTG 594: Engagement and Retention in Care for HIV+, A Multicenter Trial of the California Collaborative Treatment Group|
- Time to lost to follow up [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]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 to initiation of ART [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]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.
- Descriptive analyses [ Time Frame: Baseline to two years ] [ Designated as safety issue: No ]
Descriptive secondary analyses comparing the two randomized groups will include:
- Baseline and follow-up scores on HIV and health literacy assessments, disclosure rates, adherence, and measures of self-efficacy
- Number of primary care visits per year
- HIV RNA < 50 and <200 copies/mL at years 1 and 2
- CD4 cell counts and changes from baseline in CD4 at years 1 through 2
- Scores on Beck Depression Index
- Substance use
- HIV high-risk transmission behaviors
- Time to AIDS diagnosis or death
- Return to Care after Primary Endpoint [ Time Frame: Baseline to 2 years ] [ Designated as safety issue: No ]Proportions of subjects that meet the primary endpoint but subsequently return to care will be compared between the randomized groups. The times between last visit and return visit will also be compared between the randomized groups.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
No Intervention: Standard of Care (SoC)
Subjects randomized to the Standard of Care Arm will receive their HIV clinic's current standard of care retention services.
Active Comparator: SoC + ALERT 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.
Behavioral: SoC + ALERT Intervention
Enhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care.
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 ("out of care" defined using the gap measure ( no primary care visit in the last 180 days and not on a stable ART regimen).
Stratification: Subjects will be stratified based on primary HIV care clinic site and if they are newly diagnosed or returning to care. 100 patients per study site, 50 in the intervention arm, 50 in SoC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01957748
|Contact: Amy Sitapati, MDfirstname.lastname@example.org|
|Contact: Eric E Ellorinemail@example.com|
|United States, California|
|City of Long Beach Department of Health and Human Services||Withdrawn|
|Long Beach, California, United States, 90815|
|University Southern California||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Daisy Villafuerte 323-343-8282 firstname.lastname@example.org|
|Contact: Janisse Mercado 323.343.8282 email@example.com|
|Principal Investigator: Michael Dube, MD|
|University of California, San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Kelly Walsh, MS 619-543-8080 firstname.lastname@example.org|
|Contact: Edward Seefried, RN 619.543.8080 email@example.com|
|Principal Investigator: Amy Sitapati, MD|
|Harbor-UCLA Medical Center||Recruiting|
|Torrance, California, United States, 90502|
|Contact: Vanessa Correa 424-201-3000 ext 7302 firstname.lastname@example.org|
|Contact: Katya Calvo, MD 310.222.3848 email@example.com|
|Principal Investigator: Eric Daar, MD|
|Study Chair:||Amy Sitapati, MD||CCTG, UCSD AVRC, UCSD Owen Clinic|
|Study Chair:||Jeannette Aldous, MD||CCTG, UCSD AVRC|