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CCTG 594: Engagement and Retention in Care for HIV+

Primary Purpose

Patient Adherence, HIV Positive

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SoC + ALERT Intervention

About this trial

This is an interventional health services research trial for Patient Adherence focused on measuring Retention, Care, Engagement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Southern California
University of California, San Diego
Harbor-UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard of Care (SoC)

SoC + ALERT Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to initiation of ART

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.

Full Information

NCT ID

NCT01957748

First Posted

September 9, 2013

Last Updated

December 8, 2021

Sponsor

University of California, San Diego

Collaborators

University of California, Los Angeles, University of Southern California, City of Long Beach Department of Health and Human Services, California HIV/AIDS Research Program

1. Study Identification

Unique Protocol Identification Number

NCT01957748

Brief Title

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

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

October 8, 2013 (Actual)

Primary Completion Date

December 15, 2017 (Actual)

Study Completion Date

November 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

University of California, Los Angeles, University of Southern California, City of Long Beach Department of Health and Human Services, California HIV/AIDS Research Program

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patient Adherence, HIV Positive

Keywords

Retention, Care, Engagement

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care (SoC)

Arm Type

No Intervention

Arm Description

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

Arm Title

SoC + ALERT Intervention

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

SoC + ALERT Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to lost to follow up

Description

Time Frame

Baseline to Week 48

Secondary Outcome Measure Information:

Title

Time to initiation of ART

Description

Time Frame

Baseline to Week 48

Other Pre-specified Outcome Measures:

Title

Descriptive analyses

Description

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

Time Frame

Baseline to two years

Title

Return to Care after Primary Endpoint

Description

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.

Time Frame

Baseline to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maile Karris, MD

Organizational Affiliation

CCTG, UCSD AVRC, UCSD Owen Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Katya Calvo, MD

Organizational Affiliation

CCTG, Harbor-UCLA

Official's Role

Study Chair

Facility Information:

Facility Name

University Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

University of California, San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Harbor-UCLA Medical Center

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

12. IPD Sharing Statement

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CCTG 594: Engagement and Retention in Care for HIV+

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