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Trial of Collaborative Depression Care Management for HIV Patients

NCT ID: NCT01372605

Last Updated: 2016-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression HIV

Keywords

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Depression HIV Adherence Collaborative care Measurement-Based Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type OTHER

Enhanced Usual Care

Intervention Type OTHER

Collaborative depression care

Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.

Group Type EXPERIMENTAL

Measurement-Based Care collaborative depression management

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Enhanced Usual Care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian W Pence, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Bradley N Gaynes, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of Alabama at Birmingham 1917 Clinic

Birmingham, Alabama, United States

Site Status

University of North Carolina Hospitals Infectious Diseases Clinic

Chapel Hill, North Carolina, United States

Site Status

Duke University Clinic 2J

Durham, North Carolina, United States

Site Status

Northern Outreach Clinic

Henderson, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22542960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23134559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23442030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24103743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25105320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25727123 (View on PubMed)

Related Links

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http://slamdunc.web.unc.edu/

SLAM DUNC study website

Other Identifiers

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R01MH086362

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00019233

Identifier Type: -

Identifier Source: org_study_id