Trial of Collaborative Depression Care Management for HIV Patients (SLAM DUNC)
|ClinicalTrials.gov Identifier: NCT01372605|
Recruitment Status : Completed
First Posted : June 14, 2011
Results First Posted : October 19, 2016
Last Update Posted : November 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Depression HIV||Other: Measurement-Based Care collaborative depression management Other: Enhanced Usual Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||304 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||June 2014|
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
- Antiretroviral Medication Adherence [ Time Frame: Six months post-enrollment ]Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|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|