NCT01372605

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable depression

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 19, 2016

Completed
Last Updated

November 29, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

June 12, 2011

Results QC Date

April 11, 2016

Last Update Submit

October 19, 2016

Conditions

DepressionHIV

Keywords

DepressionHIVAdherenceCollaborative careMeasurement-Based Care

Outcome Measures

Primary Outcomes (1)

  • Antiretroviral Medication Adherence

    Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor

    Six months post-enrollment

Secondary Outcomes (10)

  • Depressive Symptoms

    Six months

  • Antiretroviral Medication Adherence

    12 months

  • Health Care Costs

    12 months

  • Appointment Adherence

    12 months

  • Number of Participants With Viral Load Below Detection

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Collaborative depression care

EXPERIMENTAL

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

Other: Measurement-Based Care collaborative depression management

Enhanced usual care

OTHER

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

Interventions

Measurement-Based Care collaborative depression managementOTHER

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

Collaborative depression care
Enhanced Usual CareOTHER
Enhanced usual care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • HIV-positive
  • Patient Health Questionnaire-9 (PHQ-9) total score \>= 10
  • Confirmed current major depressive episode
  • English-speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama at Birmingham 1917 Clinic

Birmingham, Alabama, United States

Location

University of North Carolina Hospitals Infectious Diseases Clinic

Chapel Hill, North Carolina, 27516, United States

Location

Duke University Clinic 2J

Durham, North Carolina, United States

Location

Northern Outreach Clinic

Henderson, North Carolina, 27536, United States

Location

Related Publications (6)

  • 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.

    PMID: 22542960BACKGROUND

  • 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.

    PMID: 23134559BACKGROUND

  • 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.

    PMID: 23442030BACKGROUND

  • 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.

    PMID: 24103743BACKGROUND

  • 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.

    PMID: 25105320BACKGROUND

  • 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.

    PMID: 25727123BACKGROUND

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Brian Pence
Organization
University of North Carolina-Chapel Hill
bpence@unc.edu
9199667446

Study Officials

  • Brian W Pence, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Bradley N Gaynes, MD MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2011

First Posted

June 14, 2011

Study Start

April 1, 2010

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

November 29, 2016

Results First Posted

October 19, 2016

Record last verified: 2016-10

Locations

US(4)