CCTG 593: Testing and Linkage to Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by California Collaborative Treatment Group
Sponsor:
Collaborators:
University of California, San Diego
University of California, Los Angeles
University of Southern California
City of Long Beach Department of Health and Human Services
California HIV/AIDS Research Program
Information provided by (Responsible Party):
California Collaborative Treatment Group
ClinicalTrials.gov Identifier:
NCT01941121
First received: September 9, 2013
Last updated: March 31, 2014
Last verified: March 2014

September 9, 2013
March 31, 2014
July 2013
January 2016   (final data collection date for primary outcome measure)
Acceptance of the linkage program [ Time Frame: 60 days from date of HIV screening test ] [ Designated as safety issue: No ]
The primary outcome will measure the acceptance of the linkage program, which is defined as those individuals who, after testing either positive or HIV antibody negative, will agree to be contacted by the ALERT specialist.
Same as current
Complete list of historical versions of study NCT01941121 on ClinicalTrials.gov Archive Site
  • Proportion of HIV+ linked [ Time Frame: 60 days from date of HIV screening test ] [ Designated as safety issue: No ]
    Proportion of newly diagnosed HIV+ individuals who attend an HIV primary care visit within 60 days of enrollment.
  • Proportion of HIV- linked [ Time Frame: 60 days from date of HIV screening test ] [ Designated as safety issue: No ]
    Proportion of HIV antibody negatives with high risk behavior who attend a PrEP evaluation visit within 60 days of enrollment.
Same as current
Not Provided
Not Provided
 
CCTG 593: Testing and Linkage to Care
CCTG 593: Testing and Linkage to Care, A Multicenter Demonstration Project of the California Collaborative Treatment Group

This is a CCTG sponsored project to determine if those recently screened for HIV would accept assistance to be linked into appropriate health services. After receiving their HIV results, high-risk individuals who test negative will have an option to be linked into a study that offers them Pre-exposure Prophylaxis (PrEP), and individuals who test positive will have an option to be linked into care.

If they accept, tested individuals will be in contact with an ALERT specialist that will help facilitate their linkage. The study's primary analysis will analyze how many HIV screened individuals accept the ALERT specialist assistance.

Design: CCTG 593 is a project to evaluate the uptake and effectiveness of an ALERT specialist serving to

  1. link newly diagnosed, HIV infected persons from HIV testing sites to HIV specialist providers, and
  2. link confirmed HIV antibody negative persons with continued high risk behaviors to PrEP centers

Duration: Each subject who agrees to linkage will receive ALERT follow-up until successful linkage or 60 days following enrollment, whichever comes first. The duration of the 593 project will be for 3.5 years or until all subjects have been enrolled and successfully linked, or 60 days pass.

Sample Size: Up to 600 subjects will be tested and offered linkage across all CCTG sites: LA County-USC Medical Center, Harbor-UCLA/City of Long Beach Department of Health and Human Services, UCSD/San Diego Health and Human Services Agency.

Study Population: Eligible subjects will include any persons 18 years of age or older who have been tested for HIV at one of the CCTG testing sites (LA County + USC, Long Beach Department of Health and Human Services, and San Diego Health and Human Services Agency).

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV Positive
  • HIV Seronegative
Behavioral: Linkage to PrEP or Care
Ensuring subjects complete linkage to PrEP or Care through coordinated scheduling and intensive reminders by ALERT Specialist.
Experimental: Linkage to PrEP or Care
Subjects screened for HIV at any CCTG consortium site will be offered Linkage to PrEP or Care, depending on HIV status. After results are received, HIV testers will obtain verbal consent from the subject to connect with the ALERT Specialist, or otherwise offer the subject the ALERT Specialist contact information. When contacted, the ALERT Specialist will coordinate with the subject the scheduling of the PrEP or Care visit, and remain in contact to ensure linkage.
Intervention: Behavioral: Linkage to PrEP or Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
July 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or older
  • Has had an HIV test result form the CCTG Consortium testing site as either positive or negative
  • Ability to provide informed consent
  • English or Spanish Speaking

Exclusion Criteria:

  • Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent
  • Acute medical illness that requires transfer to a non CCTG hospital
Both
18 Years and older
Yes
Contact: Kathleen Jacobson, MD 323-442-1313 kjacobso@med.usc.edu
Contact: Eric E Ellorin 619-543-5011 eellorin@ucsd.edu
United States
 
NCT01941121
CCTG 593
No
California Collaborative Treatment Group
California Collaborative Treatment Group
  • University of California, San Diego
  • University of California, Los Angeles
  • University of Southern California
  • City of Long Beach Department of Health and Human Services
  • California HIV/AIDS Research Program
Study Chair: Kathleen Jacobson, MD University of Southern California
Study Chair: Michael Menchine, MD, MPH University of Southern California
California Collaborative Treatment Group
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP