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

This study has been completed.
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
University of Alabama at Birmingham
Information provided by (Responsible Party):
Duke University Identifier:
First received: June 12, 2011
Last updated: March 27, 2015
Last verified: December 2013
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.

Condition Intervention
Other: Measurement-Based Care collaborative depression management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Depressive symptoms [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Hamilton Rating Scale for Depression symptom score at 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 HIV appointments to all kept or missed appointments (Missed Visit Proportion) during 12 months post-enrollment

  • Viral load (VL) [ 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 ]
    Short Form-12 Physical and Mental Composite scores

  • 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

  • Depression-free days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores

Enrollment: 304
Study Start Date: April 2010
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collaborative depression care
Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
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
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.

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01372605

United States, Alabama
University of Alabama at Birmingham 1917 Clinic
Birmingham, Alabama, United States
United States, North Carolina
University of North Carolina Hospitals Infectious Diseases Clinic
Chapel Hill, North Carolina, United States, 27516
Duke University Clinic 2J
Durham, North Carolina, United States
Northern Outreach Clinic
Henderson, North Carolina, United States, 27536
Sponsors and Collaborators
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
  More Information

Additional Information:

Responsible Party: Duke University Identifier: NCT01372605     History of Changes
Other Study ID Numbers: Pro00019233  R01MH086362 
Study First Received: June 12, 2011
Last Updated: March 27, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Collaborative care
Measurement-Based Care

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs processed this record on September 29, 2016