Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users (CTN0049)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Columbia University
Sponsor:
Collaborators:
Jackson Health System
Grady Health System
Johns Hopkins University
Boston Medical Center
Hahnemann University Hospital
Rush University Medical Center
PARKLAND HEALTH AND HUMAN SERVICES
University of Pittsburgh
University of California, Los Angeles
University of Alabama at Birmingham
Saint Luke's Roosevelt Hospital Center
Information provided by (Responsible Party):
Lisa Metsch, Columbia University
ClinicalTrials.gov Identifier:
NCT01612169
First received: June 4, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

Primary Objective: This study will evaluate the most effective strategy in achieving HIV virologic suppression among HIV-infected substance users recruited from the hospital setting who are randomly assigned to one of three treatment conditions: 1) Patient Navigator (PN); 2) Patient Navigator + Contingency Management (PN+CM); and 3) Treatment as Usual (TAU).

Primary Hypothesis: The rate of viral suppression (plasma HIV viral load of <= 200 copies/mL) relative to non-suppression or all-cause mortality in the 3 study groups will differ from each other at the 12 month follow-up.

Sub-hypothesis 1. The rate of virologic suppression (plasma HIV viral load of <= 200 copies/mL) in the PN+CM group will be greater than that in the TAU group.

Sub-hypothesis 2. The rate of virologic suppression in the PN+CM group will be greater than that in the PN group.

Sub-hypothesis 3. The rate of virologic suppression in the PN group will be greater than that in the TAU group.

Secondary Objectives:

  1. To evaluate the effect of the experimental interventions on: HIV virological suppression and CD4 T-cell count changes at 6 months post-randomization; engagement in HIV primary care and visit attendance; and rate of hospitalizations.
  2. To evaluate the effect of the experimental interventions on: drug use frequency and severity; and drug use treatment engagement and session attendance.
  3. To assess selected mechanisms of action of the intervention (.i.e. mediators of intervention effect).
  4. To assess potential characteristics associated with differential treatment effectiveness (i.e. moderators of intervention effect).
  5. To evaluate the incremental cost and cost-effectiveness of the interventions.

Condition Intervention
HIV
AIDS
Substance Abuse
Inpatient
Behavioral: Patient Navigation (PN) Group
Behavioral: Patient Navigator Plus Contingency Management (PN+CM) Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NIDA CTN Protocol 0049. Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • HIV Viral Suppression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary outcome variable is binary: HIV viral suppression (<= 200 copies/ml), as determined by blood draw at/near the 12 month follow-up versus presence of viral load > 200 or death (all-cause mortality). We are aware that, for patients on therapy, the goal of antiretroviral therapy is achieving a viral load "below the limit of detection of the assay" which currently is usually < 40 copies/ml. However, we have chosen to define "suppression" as <= 200 copies/ml to be consistent with the January 2011 Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.


Secondary Outcome Measures:
  • HIV Secondary Outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    1. Viral suppression at 6 months (binary; laboratory assay)
    2. CD4 Cell count (continuous; laboratory assay)
    3. Engagement into care (binary; self-report/medical record abstraction)
    4. HIV care visit attendance (count; self-report/medical record abstraction)
    5. Medication Adherence (count; self-report/ACTG Adherence Questionnaire)
    6. Hospitalizations (count; self-report/medical record abstraction)
    7. All cause mortality

  • Substance Use Related Secondary Outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    1. Substance use frequency (count; self-report ASI and binary; urine/breath analysis)
    2. Substance Use Severity (continuous, DAST and AUDIT)
    3. Treatment engagement (binary; self-report/medical record abstraction)
    4. Number of drug treatment sessions (Count; self-report/medical record abstraction)

  • Mediators and Moderators of Outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    1. Viral Suppression Moderators: psychological distress (BSI), Housing instability, Food Insecurity Health literacy, HIV-related cognitive problems, and renal and liver function status.
    2. Viral Suppression Mediators: Medication self-efficacy, Physician-Patient relationship, social support and substance use.
    3. CD4 Count Moderators: HCV status.
    4. Drug Use Moderators: Readiness for drug treatment
    5. Drug Use Mediators: Readiness for drug treatment and social support.


Estimated Enrollment: 800
Study Start Date: July 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as Usual (TAU) Group

Participants assigned to the TAU group will receive the standard treatment provided at each hospital for linking patients to HIV and substance use care.

During the formal site selection process, a thorough assessment will be conducted of each site's standard practice for linkage to HIV care and substance use treatment. Throughout the course of the trial, hospital sites will be monitored for any potential changes that might occur in standard practice around linkage to HIV care and substance use treatment.

Experimental: Patient Navigation (PN) Group

The patient navigator approach includes five functions: 1) establishing an effective working relationship; 2) encouraging identification and use of strengths, abilities and assets; 3) supporting client control over goal setting and the search for needed resources; 4) viewing the community as a resource and identifying informal sources of support; and 5) conducting case management as an active community based activity.

After the initial four meetings, patient navigators will meet with PN group participants ideally twice monthly during months 2 and 3 and once monthly during months 4 - 6.

Behavioral: Patient Navigation (PN) Group
The patient navigator approach includes five functions: 1) establishing an effective working relationship; 2) encouraging identification and use of strengths, abilities and assets; 3) supporting client control over goal setting and the search for needed resources; 4) viewing the community as a resource and identifying informal sources of support; and 5) conducting case management as an active community based activity.
Experimental: Patient Navigator Plus Contingency Management (PN+CM) Group

Study participants randomized to this group will receive the patient navigation (PN) intervention as outlined above combined with contingency management (CM). Using the principles of contingency management, this combined intervention will incorporate viral load suppression as a target of reinforcement as well as several other behaviors (HIV clinical care, medication adherence, cessation or reduction of substance use) that are hypothesized to be moderators or mediators of the primary outcome.

For participants randomly assigned to the PN+CM study group, patient navigators will: 1) effectively communicate the incentive plan to the participant, 2) track each of the seven target behaviors that may earn participant incentives, 3) verify occurrence of the target behaviors, 4) deliver incentives according to the protocol, and 5) maintain a record of incentives delivered. PNs will use a computer-based tracking program to facilitate this work.

Behavioral: Patient Navigator Plus Contingency Management (PN+CM) Group
Study participants randomized to this group will receive the patient navigation (PN) intervention as outlined above combined with contingency management (CM).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Participating individuals must:

  1. be admitted to a hospital and be HIV-infected at the time of recruitment
  2. be at least 18 years old
  3. meet one of the following: A) have an AIDS-defining illness during the current hospital admission; or B) have the most recent CD4 count and viral load performed within the past 6 months be <350 cells/uL and >200 copies/mL; or C) have the most recent CD4 count and viral load performed within the past 12 months be <=500 cells/uL and >200 copies/mL or unknown accompanied by the Site PI's discretion that the patient a) is likely to currently have a viral load >200 copies/mL, b) is not currently successfully/correctly taking antiretroviral therapy (ART) and c) needs to be on ART
  4. report (or have evidence in the medical record of) any opioid and/or stimulant and/or heavy alcohol use within the past 12 months (Note: Medical record evidence may consist of a) positive toxicology screen(s) for stimulants or heavy alcohol or b) clinician notes indicating heavy use of alcohol, use of stimulants or non-prescribed opioids or abuse of prescribed opioids.)
  5. have a Karnofsky performance scale index score of >=60
  6. provide informed consent
  7. provide locator information
  8. sign a HIPAA form / medical record release form to facilitate medical record abstraction
  9. report living in the vicinity and being able to return for follow-up visits
  10. complete the baseline assessment, including blood draw
  11. be able to communicate in English

Exclusion Criteria

Individuals will be excluded from the study if they:

  1. do not meet any one or more of the above-described inclusion criteria
  2. have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
  3. are terminated via Site PI decision with agreement from study Lead Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612169

Locations
United States, Alabama
University Hospital At University of Alabama, Birmingham (Uab) Recruiting
Birmingham, Alabama, United States, 35294
Contact: Michael Mugavero, M.D.    205-996-5822    mmugavero@uab.edu   
United States, California
Los Angeles County Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Eric Daar, M.D.    310-222-2467    edaar@labiomed.org   
United States, Florida
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Jessica Ucha, MSEd    305-243-4399    jucha@med.miami.edu   
Principal Investigator: Allan Rodriguez, M.D.         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Jessica Ucha, MSEd    305-243-4399    jucha@med.miami.edu   
Principal Investigator: Daniel Feaster, Ph.D.         
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Christin Root    404-251-8893    cmroot@emory.edu   
Principal Investigator: Carlos del Rio, M.D.         
United States, Illinois
Stroger Cook County Hospital/Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Pamela Vergara-Rodriguez, M.D.    312-572-4753    Pvergara-rodriguez@cookcountyhhs.org   
Contact: Patricia Herrera, M.D.    312-864-4593    Pherrera@cookcountyhhs.org   
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Greg Lucas, M.D.    410-614-0560    glucas@jhmi.edu   
Sub-Investigator: Greg Lucas, M.D.         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Dr. Meg Sullivan, M.D.    617-414-3574    Meg.Sullivan@bmc.org   
United States, New York
Saint Luke's Roosevelt Hospital Center Recruiting
New York, New York, United States, 10019
Contact: Hannah Wolfe, Ph.D.    212-523-6500    hwolfe@chpnet.org   
United States, Pennsylvania
Hahnemann University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Jeff Jacobson, M.D.    215-762-6555    jeffrey.jacobson@drexelmed.edu   
University of Pittsburgh Medical Center (Upmc) Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Deborah McMahon, M.D.    412-383-1675    mcmahond@pitt.edu   
United States, Texas
Parkland Health and Human Services Recruiting
Dallas, Texas, United States, 75390
Contact: Mamta K. Jain, M.D.    214-648-6703    mamta.jain@utsouthwestern.edu   
Sponsors and Collaborators
Columbia University
Jackson Health System
Grady Health System
Johns Hopkins University
Boston Medical Center
Hahnemann University Hospital
Rush University Medical Center
PARKLAND HEALTH AND HUMAN SERVICES
University of Pittsburgh
University of California, Los Angeles
University of Alabama at Birmingham
Saint Luke's Roosevelt Hospital Center
Investigators
Principal Investigator: Lisa Metsch, Ph.D Columbia University
Study Director: Lauren Gooden, Ph.D Columbia University
Principal Investigator: Carlos del Rio, M.D. Emory University
  More Information

No publications provided

Responsible Party: Lisa Metsch, Stephen Smith Professor and Chair of the Department of Sociomedical Sciences, Columbia University
ClinicalTrials.gov Identifier: NCT01612169     History of Changes
Other Study ID Numbers: AAAK1709, U10DA013720-11
Study First Received: June 4, 2012
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Columbia University:
HIV patients
Hospitalized patients
Substance Users
Drug Users

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014