HIV Positive Clinical Trial
Official title:
CCTG 593: Testing and Linkage to Care, A Multicenter Demonstration Project of the California Collaborative Treatment Group
NCT number | NCT01941121 |
Other study ID # | CCTG 593 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 26, 2013 |
Est. completion date | February 9, 2021 |
Verified date | May 2021 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | February 9, 2021 |
Est. primary completion date | January 22, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | City of Long Beach Department of Health and Human Services | Long Beach | California |
United States | University of Southern California | Los Angeles | California |
United States | University of California, San Diego | San Diego | California |
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 |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects linked to Care or PrEP | 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 | Up to 60 days for positives and up to 90 days for negatives from date of HIV screening test | |
Secondary | Acceptance of the linkage program | 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. | 60 days from date of HIV screening test |
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