Overview

This trial is active, not recruiting.

Conditions patient adherence, hiv positive
Treatment soc + alert intervention
Sponsor California Collaborative Treatment Group
Collaborator University of California, San Diego
Start date October 2013
End date March 2016
Trial size 300 participants
Trial identifier NCT01957748, CCTG 594

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
Subjects randomized to the Standard of Care Arm will receive their HIV clinic's current standard of care retention services.
(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.
soc + alert intervention
Enhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care.

Primary Outcomes

Measure
Time to lost to follow up
time frame: Baseline to Week 48

Secondary Outcomes

Measure
Time to initiation of ART
time frame: Baseline to Week 48

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title CCTG 594: Engagement and Retention in Care for HIV+, A Multicenter Trial of the California Collaborative Treatment Group
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by California Collaborative Treatment Group.