Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.

Summary

Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group).

Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ between the two study groups over the 14-month follow-up period.

Secondary Objectives:

Component 1 (Long-term CTN 0049 follow-up):

Using the CTN 0064 baseline data (self-report, medical record abstraction and biological data), the following CTN 0049 primary and secondary outcomes in participants who consented to the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the CTN 0049 interventions:

1. HIV virological suppression
2. HIV primary care visit attendance
3. All-cause mortality

Conditions

• Hepatitis C
• HIV
• AIDS
• Substance Use

Interventions

OTHER

Control Group

After screening HCV antibody positive, participants will receive an appointment and reminder card to return for their HCV RNA results. If HCV RNA positive, study staff will attempt to make an appointment for the participant's next step in the HCV continuum. If a participant attends the "next step" visit, the participant would be subject to whatever is the local standard of care at that clinic/agency from that point forward.

BEHAVIORAL

Care Facilitation Group

The same will occur for intervention participants, yet an HCV care facilitator will motivate them to return for their HCV RNA results; appointment reminders will be made prior to the "next step" visit; follow-up contact will be made for missed appointments; and the HCV care facilitator will coordinate and link the participant to available community resources (e.g., mental health, housing agencies) by scheduling appointments, arranging transportation, and helping to complete any clinic registration (or other) paperwork that agencies may require to access services.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Jackson Health System

  collaborator OTHER

• Grady Memorial Hospital

  collaborator OTHER

• St. Luke's-Roosevelt Hospital Center

  collaborator OTHER

• University of Texas

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University Hospital Birmingham

  collaborator OTHER

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• Hahnemann University Hospital

  collaborator OTHER

• Cook County Health

  collaborator OTHER_GOV

• Boston University

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• The Emmes Company, LLC

  collaborator INDUSTRY

• University of Miami

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Columbia University

  lead OTHER

Principal Investigators

• Lisa R. Metsch, PhD · Columbia University

• Carlos del Rio, MD · Emory University

• Daniel J. Feaster, PhD · University of Miami

• Carmen Masson, PhD · University of California, San Francisco

• David Perlman, MD · Mount Sinai Icahn School of Medicine

• Lauren K. Gooden, PhD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2018-05-09

Completion

2018-05-09

Countries

• United States

Study Locations