An interventional study of Collaborative Care Interventions in HIV, Depression, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-12-29.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.
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, the investigators 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. The investigators 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.
8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 249 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →VA Office of Research and Development is the lead sponsor of 1,768 studies on the registry; 393 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 183 (87%) have results posted.
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Exclusion Criteria:
HIV patients were screened for depression and the screener results were available to HIV clinicians. Depressed HIV patients received collaborative care intervention.
Behavioral: Collaborative Care Interventions
HIV patients were screened for depression and the screener results were available to HIV clinicians. Depressed HIV patients received usual care.
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.
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.
Time frame: 6 months
| Milestone | Arm 1: Collaborative Care Intervention | Arm 2: Usual Care |
|---|---|---|
| Started | 123 | 126 |
| Completed | 105 | 110 |
| Not completed | 18 | 16 |
| Withdrew: Lost to follow-up | 11 | 11 |
| Withdrew: Death | 4 | 5 |
| Withdrew: Withdrawal by subject | 3 | 0 |
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.
| percent response | Arm 1: Collaborative Care Intervention | Arm 2: Usual Care |
|---|---|---|
| Percentage of Participants With Depression Treatment Response | 33.3 | 17.5 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Collaborative Care Intervention | — | 0/123 (0%) | 0/123 (0%) |
| Arm 2: Usual Care | — | 0/126 (0%) | 0/126 (0%) |
| Age, Continuous(years) | Arm 1: Collaborative Care Intervention | Arm 2: Usual Care | Total |
|---|---|---|---|
| Mean | 49.8 ± 8.7 | 49.8 ± 10.5 | 49.8 ± 9.6 |
| Gender(Participants) | Arm 1: Collaborative Care Intervention | Arm 2: Usual Care | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 120 | 122 | 242 |
| Race (NIH/OMB)(Participants) | Arm 1: Collaborative Care Intervention | Arm 2: Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 78 | 77 | 155 |
| White | 45 | 49 | 94 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Plan to share: Yes — Investigators can request IPD by contacting the PI.
The record gives a start of Feb 2007, a primary completion of Jul 2009 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2014, 5 years 2 months after primary completion.
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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