Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users (CTN0049)
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ClinicalTrials.gov Identifier: NCT01612169 |
Recruitment Status :
Completed
First Posted : June 5, 2012
Last Update Posted : March 14, 2016
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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: 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 or disease | Intervention/treatment | Phase |
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HIV AIDS Substance Abuse Inpatient | Behavioral: Patient Navigation (PN) Group Behavioral: Patient Navigator Plus Contingency Management (PN+CM) Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 801 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | NIDA CTN Protocol 0049. Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |
Arm | Intervention/treatment |
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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 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). |
- HIV Viral Suppression [ Time Frame: 12 months ]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.
- HIV Secondary Outcomes [ Time Frame: 12 months ]
- 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 ]
- Substance use frequency (count; self-report ASI and binary; urine/breath analysis)
- 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 ]
- Viral Suppression Moderators: psychological distress (BSI), Housing instability, Food Insecurity Health literacy, HIV-related cognitive problems, and renal and liver function status.
- Viral Suppression Mediators: Medication self-efficacy, Physician-Patient relationship, social support and substance use.
- CD4 Count Moderators: HCV status.
- Drug Use Moderators: Readiness for drug treatment
- Drug Use Mediators: Readiness for drug treatment and social support.
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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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; 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612169
United States, Alabama | |
University Hospital At University of Alabama, Birmingham (Uab) | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Los Angeles County Harbor-UCLA Medical Center | |
Torrance, California, United States, 90502 | |
United States, Florida | |
Jackson Memorial Hospital | |
Miami, Florida, United States, 33136 | |
University of Miami | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
Grady Memorial Hospital | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Stroger Cook County Hospital/Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 | |
United States, New York | |
Saint Luke's Roosevelt Hospital Center | |
New York, New York, United States, 10019 | |
United States, Pennsylvania | |
Hahnemann University Hospital | |
Philadelphia, Pennsylvania, United States, 19102 | |
University of Pittsburgh Medical Center (Upmc) | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Parkland Health and Human Services | |
Dallas, Texas, United States, 75390 |
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 |
Responsible Party: | Lisa Metsch, Stephen Smith Professor and Chair of the Department of Sociomedical Sciences, Columbia University |
ClinicalTrials.gov Identifier: | NCT01612169 |
Other Study ID Numbers: |
AAAK1709 U10DA013720-11 ( U.S. NIH Grant/Contract ) |
First Posted: | June 5, 2012 Key Record Dates |
Last Update Posted: | March 14, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Information about the study and the de-identified study data will be available at https://datashare.nida.nih.gov/ within 18 months of the date the data are locked, as per the procedures of the National Drug Abuse Treatment Clinical Trials Network. |
HIV patients Hospitalized patients Substance Users Drug Users |
Substance-Related Disorders Drug Misuse Chemically-Induced Disorders Mental Disorders |