CCTG 594: Engagement and Retention in Care for HIV+

HIV Positive Clinical Trial

Official title:

CCTG 594: Engagement and Retention in Care for HIV+, A Multicenter Trial of the California Collaborative Treatment Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957748
• Other study ID #: CCTG 594
• Status: Completed
• Phase: N/A
• Start date: October 8, 2013
• Est. completion date: November 24, 2020

Study information

• Verified date: December 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 24, 2020
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Positive
• HIV Seropositivity
• Patient Adherence

Intervention

Behavioral:
• SoC + ALERT Intervention
Enhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care.

Locations

Country	Name	City	State
United States	University Southern California	Los Angeles	California
United States	University of California, San Diego	San Diego	California
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Descriptive analyses	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	Baseline to two years
Other	Return to Care after Primary Endpoint	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.	Baseline to 2 years
Primary	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	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.	Baseline to Week 48