Clinical trial NCT01957748: CCTG 594: Engagement and Retention in Care for HIV+
Official title: CCTG 594: Engagement and Retention in Care for HIV+, A Multicenter Trial of the California Collaborative Treatment Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Adherence
HIV Positive
Keywords: Retention
Care
Engagement
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of Southern California
name: City of Long Beach Department of Health and Human Services
name: California HIV/AIDS Research Program
First posted: 2013-10-08
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility 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 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.

Primary outcomes:
measure: Time to lost to follow up
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Time to initiation of ART
timeFrame: Baseline to Week 48
Other outcomes:
measure: Descriptive analyses
timeFrame: Baseline to two years
measure: Return to Care after Primary Endpoint
timeFrame: Baseline to 2 years
Locations:
city: Los Angeles
country: United States
facility: University Southern California
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
Study officials:
affiliation: CCTG, UCSD AVRC, UCSD Owen Clinic
name: Maile Karris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CCTG, Harbor-UCLA
name: Katya Calvo, MD
role: STUDY_CHAIR
References: