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Trial of Collaborative Depression Care Management for HIV Patients (SLAM DUNC)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
University of Alabama at Birmingham
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01372605
First received: June 12, 2011
Last updated: October 19, 2016
Last verified: October 2016
Results First Received: April 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
HIV
Interventions: Other: Measurement-Based Care collaborative depression management
Other: Enhanced Usual Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Collaborative Depression Care

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

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.

Participant Flow:   Overall Study
    Collaborative Depression Care   Enhanced Usual Care
STARTED   149   155 
COMPLETED   137   145 
NOT COMPLETED   12   10 
Death                1                2 
Lost to Follow-up                2                1 
Withdrawal by Subject                4                7 
Moved                3                0 
Changed medical home                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants

Reporting Groups
  Description
Collaborative Depression Care

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

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.
Total Total of all reporting groups

Baseline Measures
   Collaborative Depression Care   Enhanced Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 149   155   304 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.8  (10.3)   44.9  (9.9)   43.9  (10.1) 
Gender, Customized 
[Units: Participants]
     
Male   112   100   212 
Female   35   52   87 
Transgender   2   3   5 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   9   4   13 
Not Hispanic or Latino   140   151   291 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   1   2 
Asian   0   1   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   86   107   193 
White   58   43   101 
More than one race   2   1   3 
Unknown or Not Reported   2   2   4 
Region of Enrollment 
[Units: Participants]
     
United States   149   155   304 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Antiretroviral Medication Adherence   [ Time Frame: Six months post-enrollment ]

2.  Secondary:   Depressive Symptoms   [ Time Frame: Six months ]

3.  Secondary:   Antiretroviral Medication Adherence   [ Time Frame: 12 months ]

4.  Secondary:   Health Care Costs   [ Time Frame: 12 months ]

5.  Secondary:   Appointment Adherence   [ Time Frame: 12 months ]

6.  Secondary:   Number of Participants With Viral Load Below Detection   [ Time Frame: 6 months ]

7.  Secondary:   Quality of Life   [ Time Frame: 6 months ]

8.  Secondary:   Self Reported Adherence   [ Time Frame: 6 months ]

9.  Secondary:   Self-reported Adherence   [ Time Frame: 12 months ]

10.  Secondary:   Safety Endpoint   [ Time Frame: 12 months ]

11.  Secondary:   Depression-free Days   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Brian Pence
Organization: University of North Carolina-Chapel Hill
phone: 9199667446
e-mail: bpence@unc.edu


Publications:


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01372605     History of Changes
Other Study ID Numbers: Pro00019233
R01MH086362 ( US NIH Grant/Contract Award Number )
Study First Received: June 12, 2011
Results First Received: April 11, 2016
Last Updated: October 19, 2016