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Trial of Collaborative Depression Care Management for HIV Patients (SLAM DUNC)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
University of Alabama at Birmingham
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01372605
First received: June 12, 2011
Last updated: October 19, 2016
Last verified: October 2016
June 12, 2011
October 19, 2016
April 2010
April 2014   (Final data collection date for primary outcome measure)
Antiretroviral Medication Adherence [ Time Frame: Six months post-enrollment ]
Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor
Same as current
Complete list of historical versions of study NCT01372605 on ClinicalTrials.gov Archive Site
  • Depressive Symptoms [ Time Frame: Six months ]
    Hamilton Rating Scale for Depression (HAMD) symptom score at 6 months, assessed by blinded assessor. Possible score ranges from 0 to 50. Higher scores indicate worse depressive symptoms.
  • Antiretroviral Medication Adherence [ Time Frame: 12 months ]
    Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor
  • Health Care Costs [ Time Frame: 12 months ]
    Total health care costs over 12 months
  • Appointment Adherence [ Time Frame: 12 months ]
    Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment
  • Number of Participants With Viral Load Below Detection [ Time Frame: 6 months ]
    HIV RNA viral load below the limit of detection at 6 months
  • Quality of Life [ Time Frame: 6 months ]
    Short Form-12 Mental Composite score. Scores range from 0-100, with 50 corresponding to the mean and 10 points to the standard deviation in a normative US population. Higher scores indicate better health.
  • Self Reported Adherence [ Time Frame: 6 months ]
    Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).
  • Self-reported Adherence [ Time Frame: 12 months ]
    Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).
  • Safety Endpoint [ Time Frame: 12 months ]
    Psychiatric hospitalizations
  • Depression-free Days [ Time Frame: 12 months ]
    Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores at baseline and 3, 6, 9, and 12 months
  • Depressive Symptoms [ Time Frame: Six months ]
    Percent reduction in HAM-D symptom score from baseline to 6 months, assessed by blinded assessor
  • Antiretroviral Medication Adherence [ Time Frame: 12 months ]
    Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor
  • Cost-effectiveness [ Time Frame: 12 months ]
    Health care utilization costs vs. intervention costs after 12 months
  • Appointment Adherence [ Time Frame: 12 months ]
    Ratio of kept medical ID appointments to all kept or missed appointments (Missed Visit Proportion) during 12 months post-enrollment
  • Viral load [ Time Frame: 6 months and 12 months ]
    Comparison of percent with VL below the limit of detection at 6 months and 12 months
Not Provided
Not Provided
 
Trial of Collaborative Depression Care Management for HIV Patients
SLAM DUNC: Strategies to Link Antidepressant and Antiretroviral Management at Duke University, University of Alabama at Birmingham, Northern Outreach Clinic (Henderson, NC), and University of North Carolina
This project will integrate a depression treatment and brief medication adherence counseling intervention into clinical care at three HIV clinics and will use a randomized controlled trial to assess whether, relative to usual care, the intervention leads to improved HIV medication adherence. The depression treatment intervention uses a model known as Measurement-Based Care which equips Depression Care Managers with systematic measurement tools, a decision algorithm, and psychiatric backup and trains them to provide decision support to HIV clinicians to implement, monitor, and adjust antidepressant therapy.

Our goal in this project is to conduct a randomized controlled trial of an evidence-based depression treatment intervention known as Measurement-Based Care (MBC), combined with brief Motivational Interviewing (MI) adherence counseling, in depressed people living with HIV/AIDS to assess its impact on ART adherence and clinical outcomes. MBC employs Depression Care Managers with expertise in depression management to screen for depression and help non-psychiatric physicians implement guideline-concordant, algorithm-driven antidepressant treatment. The Depression Care Manager use standardized metrics (depressive symptoms, side effects) and an algorithm to monitor treatment response and recommend changes. Weekly supervision from a psychiatrist ensures quality care. Biweekly contact between patients and the Depression Care Manager will include brief MI adherence counseling.

We will recruit 390 people living with HIV/AIDS on antiretroviral therapy (ART) with confirmed depression, and will conduct a randomized trial of the MBC intervention versus enhanced usual care. Our aims are: (1) to test whether MBC improves ART adherence and HIV clinical outcomes, (2) to assess the cost-effectiveness of MBC, and (3) to collect process measures concerning MBC implementation to inform replication at other sites. Since the Depression Care Manager role can be effectively filled by a behavioral health provider or nurse given appropriate training and supervision and the intervention has limited time requirements, this model is potentially replicable to a wide range of resource-constrained HIV treatment settings.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • HIV
  • Other: Measurement-Based Care collaborative depression management
    Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications
  • Other: Enhanced Usual Care
  • Experimental: Collaborative depression care
    Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
    Intervention: Other: Measurement-Based Care collaborative depression management
  • Enhanced usual care
    Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
    Intervention: Other: Enhanced Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
304
June 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-65
  • HIV-positive
  • Patient Health Questionnaire-9 (PHQ-9) total score >= 10
  • Confirmed current major depressive episode
  • English-speaking

Exclusion Criteria:

  • History of bipolar disorder
  • History of psychotic disorder
  • Failure of adequate trials of two different antidepressants at effective doses in the current depressive episode
  • Current substance dependence requiring inpatient hospitalization
  • Not mentally competent
  • Acute suicidality or other psychiatric presentation requiring immediate hospitalization
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01372605
Pro00019233
R01MH086362 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Duke University
Duke University
  • National Institute of Mental Health (NIMH)
  • University of North Carolina, Chapel Hill
  • University of Alabama at Birmingham
Principal Investigator: Brian W Pence, PhD University of North Carolina, Chapel Hill
Principal Investigator: Bradley N Gaynes, MD MPH University of North Carolina, Chapel Hill
Duke University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP