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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
  Purpose
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
Depression
HIV
Other: Measurement-Based Care collaborative depression management
Other: Enhanced Usual Care

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 (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 ] [ Designated as safety issue: No ]
    Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor

  • Health Care Costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Total health care costs over 12 months

  • Appointment Adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    HIV RNA viral load below the limit of detection at 6 months

  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Psychiatric hospitalizations

  • 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 at baseline and 3, 6, 9, and 12 months


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
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.
Other: Enhanced Usual Care

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 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.

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372605

Locations
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
Investigators
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:
Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01372605     History of Changes
Other Study ID Numbers: Pro00019233  R01MH086362 
Study First Received: June 12, 2011
Results First Received: April 11, 2016
Last Updated: October 19, 2016
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on December 02, 2016