Clinical trial NCT01941121: CCTG 593: Testing and Linkage to Care
Official title: CCTG 593: Testing and Linkage to Care, A Multicenter Demonstration Project of the California Collaborative Treatment Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Positive
HIV Seronegative
Keywords: HIV Screening
Linkage to PrEP
Linkage to Care
CCTG
593
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of Southern California
name: City of Long Beach Department of Health and Human Services
name: California HIV/AIDS Research Program
First posted: 2013-09-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility 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

Primary outcomes:
measure: Proportion of subjects linked to Care or PrEP
timeFrame: Up to 60 days for positives and up to 90 days for negatives from date of HIV screening test
Secondary outcomes:
measure: Acceptance of the linkage program
timeFrame: 60 days from date of HIV screening test
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: City of Long Beach Department of Health and Human Services
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of Southern California
name: Kathleen Jacobson, MD
role: STUDY_CHAIR
affiliation: University of Southern California
name: Michael Menchine, MD, MPH
role: STUDY_CHAIR
affiliation: UC San Diego AntiViral Research Center (AVRC)
name: Jill Blumenthal, MD
role: PRINCIPAL_INVESTIGATOR
References: