HIV Translating Initiatives for Depression Into Effective Solutions

HIV, Depression Clinical Trial

— HI-TIDES  

Official title:

HIV Translating Initiatives for Depression Into Effective Solutions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00304915
• Other study ID #: MNT 05-152
• Status: Active, not recruiting
• Phase: N/A
• First received: March 16, 2006
• Last updated: October 23, 2015
• Start date: February 2007
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.

Description:

Background: Depression is the most common mental disorder in HIV infected patients. Despite the availability of efficacious treatments for depression, evidence suggests that it is under-diagnosed and under-treated in routine HIV care. To address this problem, we will adapt and implement a collaborative stepped-care model for depression treatment in HIV clinics. This proposal builds on past success of the TIDES/WAVES programs used in VA primary care. The project (HI-TIDES or HIV Translating Initiatives for Depression into Effective Solutions) will implement the primary care collaborative care model for depression treatment in HIV clinics using evidence-based implementation strategies. Objectives: The objectives of this proposal are to: 1) Develop and evaluate the process of adapting, implementing, and sustaining collaborative care for depression in VA HIV clinics, 2) Compare the quality of depression care and the clinical effectiveness of HI-TIDES to usual care in the HIV clinics, and 3) Evaluate the cost-effectiveness of patients assigned to HI-TIDES relative to patients assigned to usual care in HIV clinics. Methods: The implementation framework for this proposal is primarily informed by the Rogers diffusion of innovation model, Simpson Transfer Model, and the PRECEDE model. The VA and American Psychiatric Association Practice Guidelines inform the stepped care collaborative model intervention as source documents for summarizing the evidence for depression treatment for the general population. An expert panel will be convened to rate the quality of available evidence for depression treatment in the context of HIV. Patients will be recruited from VA HIV clinics: Little Rock, Atlanta, and Houston. The intervention will be randomized at the level of the patient. We expect to recruit a total of 140 intervention and 140 usual care patients. Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in the VA electronic medical record. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager. A formative evaluation will occur during start-up and throughout the implementation of the intervention. A summative evaluation will document the effectiveness and cost-effectiveness of the intervention using an intent to treat analysis plan. Findings: No results at this time. Status: Start-up activities. Impact: The proposed study is highly relevant to the VA and the veterans it serves for many reasons. First, the majority of VA patients with HIV are not seen in the primary care clinics and therefore will not benefit from VA's efforts in primary care settings to improve depression identification and treatment. Second, in addition to the negative outcomes of depression generally, depression in HIV patients is associated with additional negative outcomes including accelerated HIV disease progression, decreased immune system functioning, and premature death. Third, directly moving collaborative depression care from primary care clinics to HIV clinics is likely to fail for several reasons including the comorbidities associated with depressed HIV patient and the potential for drug-drug interactions. The proposed project will address these gaps and provide effectiveness and cost-effectiveness analyses to inform decisions about larger scale implementation of the HI-TIDES intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 249
• Est. completion date: June 2016
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. current 9-item Patient Health Questionnaire (PHQ-9) score of 10 or more and

2. current treatment in the HIV clinic.

Exclusion Criteria:

1. patients who do not have access to a telephone,

2. patients with current suicidal ideation,

3. patients with significant cognitive impairment as indicated by a score < 10 on the HIV Dementia Scale, and

4. patients with a chart diagnosis of schizophrenia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• HIV, Depression

Intervention

Behavioral:
• Collaborative Care Interventions
Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas
United States	Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR	No. Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (10)

Ackerman B, Pyne JM, Fortney JC. Challenges associated with being an off-site depression care manager. J Psychosoc Nurs Ment Health Serv. 2009 Apr;47(4):43-9. — View Citation

Bottonari KA, Tripathi SP, Fortney JC, Curran G, Rimland D, Rodriguez-Barradas M, Gifford AL, Pyne JM. Correlates of antiretroviral and antidepressant adherence among depressed HIV-infected patients. AIDS Patient Care STDS. 2012 May;26(5):265-73. doi: 10. — View Citation

Chapman J, Oser M, Hockemeyer J, Weitlauf J, Jones S, Cheung R. Changes in depressive symptoms and impact on treatment course among hepatitis C patients undergoing interferon-a and ribavirin therapy: a prospective evaluation. Am J Gastroenterol. 2011 Dec; — View Citation

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b0 — View Citation

Curran GM, Pyne J, Fortney JC, Gifford A, Asch SM, Rimland D, Rodriguez-Barradas M, Monson TP, Kilbourne AM, Hagedorn H, Atkinson JH. Development and implementation of collaborative care for depression in HIV clinics. AIDS Care. 2011 Dec;23(12):1626-36. d — View Citation

Fortney JC, Pyne JM, Smith JL, Curran GM, Otero JM, Enderle MA, McDougall S. Steps for implementing collaborative care programs for depression. Popul Health Manag. 2009 Apr;12(2):69-79. — View Citation

Fortney JC, Pyne JM, Steven CA, Williams JS, Hedrick RG, Lunsford AK, Raney WN, Ackerman BA, Ducker LO, Bonner LM, Smith JL. A Web-based clinical decision support system for depression care management. Am J Manag Care. 2010 Nov;16(11):849-54. — View Citation

Painter JT, Fortney JC, Gifford AL, Rimland D, Monson T, Rodriguez-Barradas MC, Pyne JM. Cost-Effectiveness of Collaborative Care for Depression in HIV Clinics. J Acquir Immune Defic Syndr. 2015 Dec 1;70(4):377-85. doi: 10.1097/QAI.0000000000000732. — View Citation

Pyne JM, Asch SM, Lincourt K, Kilbourne AM, Bowman C, Atkinson H, Gifford A. Quality indicators for depression care in HIV patients. AIDS Care. 2008 Oct;20(9):1075-83. doi: 10.1080/09540120701796884. Review. — View Citation

Pyne JM, Fortney JC, Curran GM, Tripathi S, Atkinson JH, Kilbourne AM, Hagedorn HJ, Rimland D, Rodriguez-Barradas MC, Monson T, Bottonari KA, Asch SM, Gifford AL. Effectiveness of collaborative care for depression in human immunodeficiency virus clinics. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Depression Treatment Response	Depression symptom severity over the past two weeks was measured using the Hopkins Symptom Checklist (SCL-20). The SCL-20 includes the 13-item depression scale plus 7 depression-related items from the Hopkins Symptom Checklist-90-Revised. The items are scored from 0 to 4 and averaged to provide a mean depression severity score from 0 to 4. Depression treatment response at 6-months was defined as a 50% decrease in mean SCL-20 score compared to baseline.	6 months	No

External Links

•   PubMed