CCTG 593: Testing and Linkage to Care

NCT ID: NCT01941121

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-26
• Study Completion Date: 2021-02-09

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).

Conditions

HIV Positive; HIV Seronegative

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Linkage to PrEP or Care

Intervention Type: BEHAVIORAL

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

Interventions

Linkage to PrEP or Care

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: collaborator

City of Long Beach Department of Health and Human Services

OTHER_GOV

Sponsor Role: collaborator

California HIV/AIDS Research Program

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jill Blumenthal

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Jacobson, MD

Role: STUDY_CHAIR

University of Southern California

Michael Menchine, MD, MPH

Role: STUDY_CHAIR

University of Southern California

Jill Blumenthal, MD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego AntiViral Research Center (AVRC)

Locations

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, United States

Countries

United States

Other Identifiers

CCTG 593

Identifier Type: -

Identifier Source: org_study_id