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CCTG 593: Testing and Linkage to Care

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ClinicalTrials.gov Identifier: NCT01941121
Recruitment Status : Active, not recruiting
First Posted : September 13, 2013
Last Update Posted : February 28, 2017
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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
HIV Positive HIV Seronegative Behavioral: Linkage to PrEP or Care Not Applicable

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 for linkage to care or 90 days following enrollment for linkage to PrEP, 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 for linkage to care or 90 days for linkage to PrEP.

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).


Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2013
Actual Primary Completion Date : February 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects linked to Care or PrEP [ Time Frame: Up to 60 days for positives and up to 90 days for negatives from date of HIV screening test ]
    The primary outcome will measure the proportion of subjects linked a) to HIV care within 60 days of testing HIV-positive or b) to PrEP within 90 days of testing HIV-negative


Secondary Outcome Measures :
  1. Acceptance of the linkage program [ Time Frame: 60 days from date of HIV screening test ]
    Secondary outcomes 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941121


Locations
United States, California
City of Long Beach Department of Health and Human Services
Long Beach, California, United States, 90815
University of Southern California
Los Angeles, California, United States, 90033
University of California, San Diego
San Diego, California, United States, 92103
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: California Collaborative Treatment Group
ClinicalTrials.gov Identifier: NCT01941121     History of Changes
Other Study ID Numbers: CCTG 593
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases