CCTG 594: Engagement and Retention in Care for HIV+

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by California Collaborative Treatment Group
Sponsor:
Collaborators:
University of California, San Diego
University of California, Los Angeles
University of Southern California
City of Long Beach Department of Health and Human Services
California HIV/AIDS Research Program
Information provided by (Responsible Party):
California Collaborative Treatment Group
ClinicalTrials.gov Identifier:
NCT01957748
First received: September 9, 2013
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Patient Adherence
HIV Positive
Behavioral: SoC + ALERT Intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by California Collaborative Treatment Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 300
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)
Arms Assigned Interventions
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.

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 ("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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • New patient to the clinic (defined as having their intake visit within 90 days of first testing positive for HIV) 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957748

Contacts
Contact: Amy Sitapati, MD 619-543-2535 asitapati@ucsd.edu
Contact: Eric E Ellorin 619.543.5011 eellorin@ucsd.edu

Locations
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    dvillafu@usc.edu   
Contact: Janisse Mercado    323.343.8282    janissem@usc.edu   
Principal Investigator: Michael Dube, MD         
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Kelly Walsh, MS    619-543-8080    krwalsh@ucsd.edu   
Contact: Edward Seefried, RN    619.543.8080    eseefried@ucsd.edu   
Principal Investigator: Amy Sitapati, MD         
Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Vanessa Correa    424-201-3000 ext 7302    vcorrea@labiomed.org   
Contact: Katya Calvo, MD    310.222.3848    kcalvo@labiomed.org   
Principal Investigator: Eric Daar, MD         
Sponsors and Collaborators
California Collaborative Treatment Group
University of California, San Diego
University of California, Los Angeles
University of Southern California
City of Long Beach Department of Health and Human Services
California HIV/AIDS Research Program
Investigators
Study Chair: Amy Sitapati, MD CCTG, UCSD AVRC, UCSD Owen Clinic
Study Chair: Jeannette Aldous, MD CCTG, UCSD AVRC
  More Information

No publications provided

Responsible Party: California Collaborative Treatment Group
ClinicalTrials.gov Identifier: NCT01957748     History of Changes
Other Study ID Numbers: CCTG 594
Study First Received: September 9, 2013
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by California Collaborative Treatment Group:
Retention
Care
Engagement

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014