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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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: December 18, 2013
Last verified: December 2013

June 12, 2011
December 18, 2013
April 2010
April 2014   (final data collection date for primary outcome measure)
Antiretroviral medication adherence [ Time Frame: Six months post-enrollment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    Percent reduction in HAM-D symptom score from baseline to 6 months, assessed by blinded assessor
  • Antiretroviral medication adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor
  • Cost-effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Health care utilization costs vs. intervention costs after 12 months
  • Appointment adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Comparison of percent with VL below the limit of detection at 6 months and 12 months
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Self Reported Adherence [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    participant reported adherence
  • Pill Count Adherence [ Time Frame: 1-6 months, 3-6 months ] [ Designated as safety issue: No ]
  • Safety Endpoints [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    suicidal ideation, hospitalizations, emergency room visits
  • Depressive symptoms [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Percent reduction in HAM-D symptom score from baseline to 6 months, assessed by blinded assessor
  • Antiretroviral medication adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor
  • Cost-effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Health care utilization costs vs. intervention costs after 12 months
  • Appointment adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Strategies to Link Antidepressant and Antiretroviral Management at Duke, UAB and UNC

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 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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
  • 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
  • No Intervention: 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.
Pence BW, Gaynes BN, Williams Q, Modi R, Adams J, Quinlivan EB, Heine A, Thielman N, Mugavero MJ. Assessing the effect of Measurement-Based Care depression treatment on HIV medication adherence and health outcomes: rationale and design of the SLAM DUNC Study. Contemp Clin Trials. 2012 Jul;33(4):828-38. doi: 10.1016/j.cct.2012.04.002. Epub 2012 Apr 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
390
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-65
  • HIV-positive
  • PHQ9 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01372605
Pro00019233, R01MH086362
Yes
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 Duke University
Principal Investigator: Bradley N Gaynes, MD MPH University of North Carolina, Chapel Hill
Duke University
December 2013

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