Trial of Collaborative Depression Care Management for HIV Patients (SLAM DUNC)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Strategies to Link Antidepressant and Antiretroviral Management at Duke, UAB and UNC |
- 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
- 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
| Estimated Enrollment: | 390 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | October 2013 (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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Brian W Pence, PhD | 919-613-5443 | brian.pence@duke.edu |
| Contact: Bradley N Gaynes, MD MPH | 919-966-8028 | bradley_gaynes@med.unc.edu |
| United States, Alabama | |
| University of Alabama at Birmingham 1917 Clinic | Not yet recruiting |
| Birmingham, Alabama, United States | |
| Principal Investigator: Michael J Mugavero, MD MHSc | |
| Sub-Investigator: James Willig, MD | |
| Sub-Investigator: James Raper | |
| United States, North Carolina | |
| University of North Carolina Hospitals Infectious Diseases Clinic | Recruiting |
| Chapel Hill, North Carolina, United States, 27516 | |
| Principal Investigator: Evelyn B Quinlivan, MD | |
| Sub-Investigator: Amy Heine | |
| Duke University Clinic 2J | Recruiting |
| Durham, North Carolina, United States | |
| Sub-Investigator: Nathan M Thielman, MD MPH | |
| Sub-Investigator: Julie Adams, MD MPH | |
| Principal Investigator: | Brian W Pence, PhD | Duke University |
| Principal Investigator: | Bradley N Gaynes, MD MPH | University of North Carolina, Chapel Hill |
More Information
Additional Information:
No publications provided by Duke University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01372605 History of Changes |
| Other Study ID Numbers: | Pro00019233, R01MH086362 |
| Study First Received: | June 12, 2011 |
| Last Updated: | December 3, 2012 |
| 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 Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 05, 2013
