Overview

This trial is active, not recruiting.

Conditions hiv positive, hiv seronegative
Treatment linkage to prep or care
Sponsor California Collaborative Treatment Group
Collaborator University of California, San Diego
Start date July 2013
End date February 2016
Trial size 600 participants
Trial identifier NCT01941121, CCTG 593

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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.
linkage to prep or care
Ensuring subjects complete linkage to PrEP or Care through coordinated scheduling and intensive reminders by ALERT Specialist.

Primary Outcomes

Measure
Proportion of subjects linked to Care or PrEP
time frame: 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
time frame: 60 days from date of HIV screening test

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title CCTG 593: Testing and Linkage to Care, A Multicenter Demonstration Project of the California Collaborative Treatment Group
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by California Collaborative Treatment Group.