Trial of Collaborative Depression Care Management for HIV Patients

Depression Clinical Trial

— SLAM DUNC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372605
• Other study ID #: Pro00019233
• Secondary ID: R01MH086362
• Status: Completed
• Phase: N/A
• First received: June 12, 2011
• Last updated: March 27, 2015
• Start date: April 2010
• Est. completion date: June 2014

Study information

• Verified date: December 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• HIV

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham 1917 Clinic	Birmingham	Alabama
United States	University of North Carolina Hospitals Infectious Diseases Clinic	Chapel Hill	North Carolina
United States	Duke University Clinic 2J	Durham	North Carolina
United States	Northern Outreach Clinic	Henderson	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH), University of Alabama at Birmingham, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (6)

Adams JL, Gaynes BN, McGuinness T, Modi R, Willig J, Pence BW. Treating depression within the HIV "medical home": a guided algorithm for antidepressant management by HIV clinicians. AIDS Patient Care STDS. 2012 Nov;26(11):647-54. doi: 10.1089/apc.2012.0113. Review. — View Citation

Bengtson AM, Pence BW, O'Donnell J, Thielman N, Heine A, Zinski A, Modi R, McGuinness T, Gaynes B. Improvements in depression and changes in quality of life among HIV-infected adults. AIDS Care. 2015;27(1):47-53. doi: 10.1080/09540121.2014.946386. Epub 2014 Aug 8. — View Citation

Bess KD, Adams J, Watt MH, O'Donnell JK, Gaynes BN, Thielman NM, Heine A, Zinski A, Raper JL, Pence BW. Providers' attitudes towards treating depression and self-reported depression treatment practices in HIV outpatient care. AIDS Patient Care STDS. 2013 Mar;27(3):171-80. doi: 10.1089/apc.2012.0406. Epub 2013 Feb 26. — View Citation

Edwards M, Quinlivan EB, Bess K, Gaynes BN, Heine A, Zinski A, Modi R, Pence BW. Implementation of PHQ-9 depression screening for HIV-infected patients in a real-world setting. J Assoc Nurses AIDS Care. 2014 May-Jun;25(3):243-52. doi: 10.1016/j.jana.2013.05.004. Epub 2013 Oct 5. — View Citation

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. — View Citation

Pence BW, Quinlivan EB, Heine A, Edwards M, Thielman NM, Gaynes BN. When "need plus supply" does not equal demand: challenges in uptake of depression treatment in HIV clinical care. Psychiatr Serv. 2015 Mar 1;66(3):321-3. doi: 10.1176/appi.ps.201400132. Epub 2014 Dec 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiretroviral medication adherence	Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor	Six months post-enrollment	No
Secondary	Depressive symptoms	Hamilton Rating Scale for Depression symptom score at 6 months, assessed by blinded assessor	Six months	No
Secondary	Antiretroviral medication adherence	Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor	12 months	No
Secondary	Cost-effectiveness	Health care utilization costs vs. intervention costs after 12 months	12 months	No
Secondary	Appointment adherence	Ratio of kept HIV appointments to all kept or missed appointments (Missed Visit Proportion) during 12 months post-enrollment	12 months	No
Secondary	Viral load (VL)	Comparison of percent with VL below the limit of detection at 6 months and 12 months	6 months and 12 months	No
Secondary	Quality of Life	Short Form-12 Physical and Mental Composite scores	6 months	No
Secondary	Self Reported Adherence	participant reported adherence	6 and 12 months	No
Secondary	Pill Count Adherence		1-6 months, 3-6 months	No
Secondary	Safety Endpoints	suicidal ideation, hospitalizations, emergency room visits	12 months	Yes
Secondary	Depression-free days	Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores	12 months	No

External Links

•   SLAM DUNC study website