CCTG 594: Engagement and Retention in Care for HIV+

NCT01957748 | Completed

• 1 other identifier: CCTG 594
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 3

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.

Conditions

Patient Adherence; HIV Positive

Keywords

Retention; Care; Engagement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to initiation of ART

  Baseline to Week 48

Other Outcomes (2)

• Descriptive analyses

  Baseline to two years

• Return to Care after Primary Endpoint

  Baseline to 2 years

Study Arms (2)

Standard of Care (SoC)

NO INTERVENTION

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

SoC + ALERT Intervention

ACTIVE COMPARATOR

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

Interventions

SoC + ALERT Intervention BEHAVIORAL

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

SoC + ALERT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• University of California, Los Angeles: collaborator
• University of Southern California: collaborator
• City of Long Beach Department of Health and Human Services: collaborator
• California HIV/AIDS Research Program: collaborator

Study Sites (3)

University Southern California

Los Angeles, California, 90033, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Patient Compliance; HIV Seropositivity

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Maile Karris, MD

  CCTG, UCSD AVRC, UCSD Owen Clinic

  PRINCIPAL INVESTIGATOR

• Katya Calvo, MD

  CCTG, Harbor-UCLA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: October 8, 2013
• Study Start: October 8, 2013
• Primary Completion: December 15, 2017
• Study Completion: November 24, 2020
• Last Updated: December 9, 2021

Record last verified: 2021-12

Locations

US (3)