Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users
CTN0049
NIDA CTN Protocol 0049. Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users
2 other identifiers
interventional
801
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Jul 2012
Typical duration for not_applicable hiv
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 5, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMarch 14, 2016
March 1, 2016
2.9 years
June 4, 2012
March 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HIV Viral Suppression
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.
12 months
Secondary Outcomes (3)
HIV Secondary Outcomes
12 months
Substance Use Related Secondary Outcomes
12 months
Mediators and Moderators of Outcomes
12 months
Study Arms (3)
Treatment as Usual (TAU) Group
NO INTERVENTIONParticipants 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.
Patient Navigation (PN) Group
EXPERIMENTALThe 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.
Patient Navigator Plus Contingency Management (PN+CM) Group
EXPERIMENTALStudy 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.
Interventions
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.
Study participants randomized to this group will receive the patient navigation (PN) intervention as outlined above combined with contingency management (CM).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Individuals will be excluded from the study if they:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Jackson Health Systemcollaborator
- Grady Health Systemcollaborator
- Johns Hopkins Universitycollaborator
- Boston Medical Centercollaborator
- Hahnemann University Hospitalcollaborator
- Rush University Medical Centercollaborator
- PARKLAND HEALTH AND HUMAN SERVICEScollaborator
- University of Pittsburghcollaborator
- University of California, Los Angelescollaborator
- University of Alabama at Birminghamcollaborator
- St. Luke's-Roosevelt Hospital Centercollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (12)
University Hospital At University of Alabama, Birmingham (Uab)
Birmingham, Alabama, 35294, United States
Los Angeles County Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Miami
Miami, Florida, 33136, United States
Grady Memorial Hospital
Atlanta, Georgia, 30322, United States
Stroger Cook County Hospital/Rush University Medical Center
Chicago, Illinois, 60612, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Saint Luke's Roosevelt Hospital Center
New York, New York, 10019, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102, United States
University of Pittsburgh Medical Center (Upmc)
Pittsburgh, Pennsylvania, 15213, United States
Parkland Health and Human Services
Dallas, Texas, 75390, United States
Related Publications (8)
Gutkind S, Starbird LE, Murphy SM, Teixeira PA, Gooden LK, Matheson T, Feaster DJ, Jain MK, Masson CL, Perlman DC, Del Rio C, Metsch LR, Schackman BR. Cost of Hepatitis C care facilitation for HIV/Hepatitis C Co-infected people who use drugs. Drug Alcohol Depend. 2022 Mar 1;232:109265. doi: 10.1016/j.drugalcdep.2022.109265. Epub 2022 Jan 10.
PMID: 35042101DERIVEDStitzer ML, Gukasyan N, Matheson T, Sorensen JL, Feaster DJ, Duan R, Gooden L, Del Rio C, Metsch LR. Enhancing patient navigation with contingent financial incentives for substance use abatement in persons with HIV and substance use. Psychol Addict Behav. 2020 Feb;34(1):23-30. doi: 10.1037/adb0000504. Epub 2019 Aug 22.
PMID: 31436447DERIVEDMitchell SG, Monico LB, Stitzer M, Matheson T, Sorensen JL, Feaster DJ, Schwartz RP, Metsch L. How patient navigators view the use of financial incentives to influence study involvement, substance use, and HIV treatment. J Subst Abuse Treat. 2018 Nov;94:18-23. doi: 10.1016/j.jsat.2018.07.009. Epub 2018 Jul 22.
PMID: 30243412DERIVEDPhilbin MM, Feaster DJ, Gooden L, Duan R, Das M, Jacobs P, Lucas GM, Batey DS, Nijhawan A, Jacobson JM, Mandler R, Daar E, McMahon DK, Armstrong WS, Del Rio C, Metsch LR. The North-South Divide: Substance Use Risk, Care Engagement, and Viral Suppression Among Hospitalized Human Immunodeficiency Virus-Infected Patients in 11 US Cities. Clin Infect Dis. 2019 Jan 1;68(1):146-149. doi: 10.1093/cid/ciy506.
PMID: 29920584DERIVEDStitzer ML, Hammond AS, Matheson T, Sorensen JL, Feaster DJ, Duan R, Gooden L, Del Rio C, Metsch LR. Enhancing Patient Navigation with Contingent Incentives to Improve Healthcare Behaviors and Viral Load Suppression of Persons with HIV and Substance Use. AIDS Patient Care STDS. 2018 Jul;32(7):288-296. doi: 10.1089/apc.2018.0014. Epub 2018 Jun 8.
PMID: 29883190DERIVEDWinhusen T, Feaster DJ, Duan R, Brown JL, Daar ES, Mandler R, Metsch LR. Baseline Cigarette Smoking Status as a Predictor of Virologic Suppression and CD4 Cell Count During One-Year Follow-Up in Substance Users with Uncontrolled HIV Infection. AIDS Behav. 2018 Jun;22(6):2026-2032. doi: 10.1007/s10461-017-1928-x.
PMID: 29030717DERIVEDStitzer M, Matheson T, Cunningham C, Sorensen JL, Feaster DJ, Gooden L, Hammond AS, Fitzsimons H, Metsch LR. Enhancing patient navigation to improve intervention session attendance and viral load suppression of persons with HIV and substance use: a secondary post hoc analysis of the Project HOPE study. Addict Sci Clin Pract. 2017 Jun 27;12(1):16. doi: 10.1186/s13722-017-0081-1.
PMID: 28651612DERIVEDMetsch LR, Feaster DJ, Gooden L, Matheson T, Stitzer M, Das M, Jain MK, Rodriguez AE, Armstrong WS, Lucas GM, Nijhawan AE, Drainoni ML, Herrera P, Vergara-Rodriguez P, Jacobson JM, Mugavero MJ, Sullivan M, Daar ES, McMahon DK, Ferris DC, Lindblad R, VanVeldhuisen P, Oden N, Castellon PC, Tross S, Haynes LF, Douaihy A, Sorensen JL, Metzger DS, Mandler RN, Colfax GN, del Rio C. Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial. JAMA. 2016 Jul 12;316(2):156-70. doi: 10.1001/jama.2016.8914.
PMID: 27404184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Stephen Smith Professor and Chair of the Department of Sociomedical Sciences
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 5, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
March 14, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will share
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.