HIV Positive, HIV Seronegative
Conditions
Keywords
HIV Screening, Linkage to PrEP, Linkage to Care, CCTG, 593
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.
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).
Interventions
BEHAVIORALLinkage to PrEP or Care
Ensuring subjects complete linkage to PrEP or Care through coordinated scheduling and intensive reminders by ALERT Specialist.
Sponsors
University of California, Los Angeles
University of Southern California
City of Long Beach Department of Health and Human Services
California HIV/AIDS Research Program
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects linked to Care or PrEP | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of the linkage program | 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. |
Countries
United States
Outcome results
None listed