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Trial record 1 of 33 for:    " August 21, 2013":" September 20, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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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
  Purpose

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.


Condition Intervention
HIV Positive
HIV Seronegative
Behavioral: Linkage to PrEP or Care

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: CCTG 593: Testing and Linkage to Care, A Multicenter Demonstration Project of the California Collaborative Treatment Group

Resource links provided by NLM:


Further study details as provided by California Collaborative Treatment Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 600
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Linkage to PrEP or Care
Ensuring subjects complete linkage to PrEP or Care through coordinated scheduling and intensive reminders by ALERT Specialist.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941121

Contacts
Contact: Kathleen Jacobson, MD 323-442-1313 kjacobso@med.usc.edu
Contact: Eric E Ellorin 619-543-5011 eellorin@ucsd.edu

Locations
United States, California
City of Long Beach Department of Health and Human Services Recruiting
Long Beach, California, United States, 90815
Contact: Kerry Brown    562-570-4125    kerry.brown@longbeach.gov   
Contact: Michael Crump    562-570-4125    michael.crump@longbeach.gov   
Sub-Investigator: Deborah Collins, PA-C         
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Kathleen Jacobson, MD    323-442-1313    kjacobso@med.usc.edu   
Contact: Connie Funk, RN    323-343-8282    funk@usc.edu   
Principal Investigator: Kathleen Jacobson, MD         
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Jill Blumenthal, MD    619-471-3913    jblumenthal@ad.ucsd.edu   
Contact: Kelly Walsh, MS    619.543.8080    krwalsh@ucsd.edu   
Principal Investigator: Jill Blumenthal, MD         
University of California, Los Angeles (Harbor) Withdrawn
Torrance, California, United States, 90502
Sponsors and Collaborators
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
Investigators
Study Chair: Kathleen Jacobson, MD University of Southern California
Study Chair: Michael Menchine, MD, MPH University of Southern California
  More Information

No publications provided

Responsible Party: California Collaborative Treatment Group
ClinicalTrials.gov Identifier: NCT01941121     History of Changes
Other Study ID Numbers: CCTG 593
Study First Received: September 9, 2013
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by California Collaborative Treatment Group:
HIV Screening
Linkage to PrEP
Linkage to Care
CCTG
593

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014