Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users (CTN0049)
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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:
- 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.
- To evaluate the effect of the experimental interventions on: self-reported drug use frequency and severity; and drug use treatment engagement and session attendance.
- To assess selected mechanisms of action of the intervention (.i.e. mediators of intervention effect).
- To assess potential characteristics associated with differential treatment effectiveness (i.e. moderators of intervention effect).
- 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 |
- HIV Viral Suppression [ Time Frame: 12 months ] [ Designated as safety issue: No ]The primary outcome variable is binary: HIV viral suppression (< 200copies/ml), as determined by blood draw at 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.
- HIV Secondary Outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Viral suppression at 6 months (binary; laboratory assay)
- CD4 Cell count (continuous; laboratory assay)
- Engagement into care (binary; self-report/medical record abstraction)
- HIV care visit attendance (count; self-report/medical record abstraction)
- Medication Adherence (count; self-report/ACTG Adherence Questionnaire)
- Hospitalizations (count; self-report/medical record abstraction)
- All cause mortality
- Substance Use Related Secondary Outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Self-reported substance use days (count; self-report ASI)
- Substance Use Severity (continuous, DAST and AUDIT)
- Treatment engagement (binary; self-report/medical record abstraction)
- 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 ]
- Viral Suppression Moderators: psychological distress (BSI), Housing instability, Food Insecurity Health literacy, HIV-related cognitive problems and HIV Information/Knowledge.
- Viral Suppression Mediators: Motivation to change HIV care behaviors, Medication self-efficacy, Physician-Patient relationship, social support and substance use.
- Drug Use Moderators: Readiness for drug treatment
- Drug Use Mediators: Readiness for drug treatment and social support.
| Estimated Enrollment: | 800 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (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. |
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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 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.
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|
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).
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Participating individuals must:
- be admitted to a hospital and be HIV-infected at the time of recruitment
- be at least 18 years old
- meet one of the following: A) have an AIDS-defining illness during the current hospital admission; 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
- 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.)
- have a Karnofsky performance scale index score of >=60
- provide informed consent
- provide locator information
- sign a HIPAA form / medical record release form to facilitate medical record abstraction
- report living in the vicinity and being able to return for follow-up visits
- complete the baseline assessment, including blood draw
- be able to communicate in English
Exclusion Criteria
Individuals will be excluded from the study if they:
- do not meet any one or more of the above-described inclusion criteria
- have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
- are terminated via Site PI decision with agreement from study Lead Investigator
Contacts and 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 | |
| Rush University Medical Center/Stroger Cook County Hospital | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Kimberly Smith, M.D. 312-942-3534 Kimberly_Y_Smith@rush.edu | |
| United States, Maryland | |
| John 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, 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 | |
| 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: | February 7, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Data and Safety Monitoring Board |
Keywords provided by Columbia University:
|
HIV patients Hospitalized patients Crack-Cocaine Users Drug Users |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013