CCTG 594: Engagement and Retention in Care for HIV+

NCT ID: NCT01957748

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-08
• Study Completion Date: 2020-11-24

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.

Conditions

Patient Adherence; HIV Positive

Keywords

Retention; Care; Engagement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard of Care (SoC)

Subjects randomized to the Standard of Care Arm will receive their HIV clinic's current standard of care retention services.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

SoC + ALERT Intervention

Intervention Type: BEHAVIORAL

Enhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care.

Interventions

SoC + ALERT Intervention

Enhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: collaborator

City of Long Beach Department of Health and Human Services

OTHER_GOV

Sponsor Role: collaborator

California HIV/AIDS Research Program

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Maile Young Karris

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maile Karris, MD

Role: PRINCIPAL_INVESTIGATOR

CCTG, UCSD AVRC, UCSD Owen Clinic

Katya Calvo, MD

Role: STUDY_CHAIR

CCTG, Harbor-UCLA

Locations

University Southern California

Los Angeles, California, United States

University of California, San Diego

San Diego, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CCTG 594

Identifier Type: -

Identifier Source: org_study_id