CCTG 593: Testing and Linkage to Care

NCT01941121 | Completed

• 1 other identifier: CCTG 593
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Positive; HIV Seronegative

Keywords

HIV Screening; Linkage to PrEP; Linkage to Care; CCTG; 593

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptance of the linkage program

  60 days from date of HIV screening test

Study Arms (1)

Linkage to PrEP or Care

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.

Behavioral: Linkage to PrEP or Care

Interventions

Linkage to PrEP or Care BEHAVIORAL

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

Linkage to PrEP or Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• University of California, Los Angeles: collaborator
• University of Southern California: collaborator
• City of Long Beach Department of Health and Human Services: collaborator
• California HIV/AIDS Research Program: collaborator

Study Sites (3)

City of Long Beach Department of Health and Human Services

Long Beach, California, 90815, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Kathleen Jacobson, MD

  University of Southern California

  STUDY CHAIR

• Michael Menchine, MD, MPH

  University of Southern California

  STUDY CHAIR

• Jill Blumenthal, MD

  UC San Diego AntiViral Research Center (AVRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 13, 2013
• Study Start: July 26, 2013
• Primary Completion: January 22, 2018
• Study Completion: February 9, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-05

Locations

US (3)