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
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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 |
Design: CCTG 593 is a project to evaluate the uptake and effectiveness of an ALERT specialist serving to
- link newly diagnosed, HIV infected persons from HIV testing sites to HIV specialist providers, and
- 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 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 |

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.
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Behavioral: Linkage to PrEP or Care
Ensuring subjects complete linkage to PrEP or Care through coordinated scheduling and intensive reminders by ALERT Specialist.
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- 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
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
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 |
Study Chair: | Kathleen Jacobson, MD | University of Southern California | |
Study Chair: | Michael Menchine, MD, MPH | University of Southern California |
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 |