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

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 Overview

• Status: Completed
• Conditions: Patient Adherence; HIV Positive
• Intervention / Treatment: Behavioral: SoC + ALERT Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University Southern California
    • San Diego, California, United States, 92103
      • University of California, San Diego
    • Torrance, California, United States, 90502
      • Harbor-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 48

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive analyses	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	Baseline to two years
Return to Care after Primary Endpoint	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.	Baseline to 2 years

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: University of California, Los Angeles; University of Southern California; California HIV/AIDS Research Program; City of Long Beach Department of Health and Human Services
• Investigators: Principal Investigator: Maile Karris, MD, CCTG, UCSD AVRC, UCSD Owen Clinic; Study Chair: Katya Calvo, MD, CCTG, Harbor-UCLA

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2013
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): November 24, 2020

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Retention; Care; Engagement
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: CCTG 594