CCTG 593: Testing and Linkage to Care

HIV Positive Clinical Trial

Official title:

CCTG 593: Testing and Linkage to Care, A Multicenter Demonstration Project of the California Collaborative Treatment Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941121
• Other study ID #: CCTG 593
• Status: Completed
• Phase: N/A
• Start date: July 26, 2013
• Est. completion date: February 9, 2021

Study information

• Verified date: May 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• HIV Positive
• HIV Seronegative
• HIV Seropositivity

Intervention

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

Locations

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

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

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