HIV, DepressionHI-TIDESNCT00304915
HIV Translating Initiatives for Depression Into Effective Solutions
A study testing Collaborative Care Interventions in people with HIV, Depression, run by VA Office of Research and Development at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV, Depression
- What is being tested?
- Collaborative Care Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current 9-item Patient Health Questionnaire (PHQ-9) score of 10 or more and
- current treatment in the HIV clinic.
Who cannot join
- patients who do not have access to a telephone,
- patients with current suicidal ideation,
- patients with significant cognitive impairment as indicated by a score < 10 on the HIV Dementia Scale, and
- patients with a chart diagnosis of schizophrenia.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, 72114-1706
About this study
This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.
Read the detailed 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, 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.
- Conditions
- HIV, Depression
- Being tested
- Collaborative Care Interventions
- Keywords
- HIV, depression, patient care management, patient care team
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Care InterventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Collaborative Care Intervention | Experimental | HIV patients were screened for depression and the screener results were available to HIV clinicians. Depressed HIV patients received collaborative care intervention. Receives: Behavioral: Collaborative Care Interventions |
| Arm 2: Usual Care | No intervention | HIV patients were screened for depression and the screener results were available to HIV clinicians. Depressed HIV patients received usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startFeb 2007
- Primary completionJul 2009
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIV, DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeffrey M Pyne, MD, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304915
- Sponsor's protocol ID
- MNT 05-152
- Acronym
- HI-TIDES
- Status last verified
- Nov 2016
- First submitted
- 16 Mar 2006
- Last updated
- 29 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Investigators can request IPD by contacting the PI.
Publications
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.
PubMed 18825515Fortney 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. doi: 10.1089/pop.2008.0023.
PubMed 19320606Ackerman 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. doi: 10.3928/02793695-20090401-01.
PubMed 19437931Pyne 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. Arch Intern Med. 2011 Jan 10;171(1):23-31. doi: 10.1001/archinternmed.2010.395.
PubMed 21220657Curran 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. doi: 10.1080/09540121.2011.579943. Epub 2011 Jun 30.
PubMed 21714689Fortney 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.
PubMed 21348556Chapman 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-alpha and ribavirin therapy: a prospective evaluation. Am J Gastroenterol. 2011 Dec;106(12):2123-32. doi: 10.1038/ajg.2011.252. Epub 2011 Aug 9.
PubMed 21826113Curran 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.0b013e3182408812.
PubMed 22310560Bottonari 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: 10.1089/apc.2011.0218. Epub 2012 Mar 21.
PubMed 22536930Painter 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.
PubMed 26102447
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Translating Initiatives for Depression Into Effective Solutions
- ClinicalTrials.gov ID
- NCT00304915
- Acronym / sponsor ID
- HI-TIDES / MNT 05-152
- Conditions
- HIV, Depression
- Keywords
- HIV, depression, patient care management, patient care team
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Feb 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Mar 2006 (estimated)
- Results
- Posted 17 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.
Detailed 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Collaborative Care Intervention | Experimental | Behavioral: Collaborative Care InterventionsHIV patients were screened for depression and the screener results were available to HIV clinicians. Depressed HIV patients received collaborative care intervention. |
| Arm 2: Usual Care | No intervention | –HIV patients were screened for depression and the screener results were available to HIV clinicians. Depressed HIV patients received usual care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- current 9-item Patient Health Questionnaire (PHQ-9) score of 10 or more and
- current treatment in the HIV clinic.
Key exclusion criteria (4 listed)
- patients who do not have access to a telephone,
- patients with current suicidal ideation,
- patients with significant cognitive impairment as indicated by a score < 10 on the HIV Dementia Scale, and
- patients with a chart diagnosis of schizophrenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Care InterventionsPatients 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. | Behavioural | Arm 1: Collaborative Care Intervention |
Primary outcome
Percentage of Participants With Depression Treatment Response
Time frame: 6 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18825515Pyne 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.
- Results publication: PubMed 19320606Fortney 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. doi: 10.1089/pop.2008.0023.
- Results publication: PubMed 19437931Ackerman 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. doi: 10.3928/02793695-20090401-01.
- Results publication: PubMed 21220657Pyne 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. Arch Intern Med. 2011 Jan 10;171(1):23-31. doi: 10.1001/archinternmed.2010.395.
- Results publication: PubMed 21714689Curran 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. doi: 10.1080/09540121.2011.579943. Epub 2011 Jun 30.
- Results publication: PubMed 21348556Fortney 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.
- Results publication: PubMed 21826113Chapman 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-alpha and ribavirin therapy: a prospective evaluation. Am J Gastroenterol. 2011 Dec;106(12):2123-32. doi: 10.1038/ajg.2011.252. Epub 2011 Aug 9.
- Results publication: PubMed 22310560Curran 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.0b013e3182408812.
- Results publication: PubMed 22536930Bottonari 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: 10.1089/apc.2011.0218. Epub 2012 Mar 21.
- Results publication: PubMed 26102447Painter 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.
- PubMedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Investigators can request IPD by contacting the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey M Pyne, MD principal investigator
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care Interventions in people with HIV, Depression, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Depression Treatment Response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00304915, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.