Antidepressant Medication Plus Directly Observed Therapy for Improving Adherence to Antiretroviral Therapy
NCT ID: NCT00338767
Last Updated: 2013-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2001-01-31
2006-08-31
Brief Summary
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Detailed Description
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Participants in this 9-month, open-label study will be randomly assigned to a treatment group or a control group. The control group will be given the phone number of the University of California, San Francisco AIDS Health Project (AHP) to call and make an appointment with a psychiatrist. Participants who attend appointments will be evaluated to determine their mental health status. Participants who are deemed to benefit from treatment will be scheduled for regular appointments at the AHP, but will be responsible for administering their own medications. The treatment group will meet with a study psychiatrist, who will prescribe an appropriate antidepressant medication. Subsequent meetings with the psychiatrist will occur weekly for the first 3 weeks, and then monthly for the duration of the study. Additionally, participants will have DOT visits every weekday morning for 1 month to take their antidepressant medications. After the first month, DOT visits will occur weekly or biweekly, depending on the medication regimen. If an individual does not attend a visit, study staff will try to locate the individual in the neighborhood to deliver the medication. Medication for the weekend will be prepared by study staff, but participants will take it on their own at home. For the last 2 months of the study, DOT visits will occur once monthly, at which time participants will receive their entire month's supply of medication.
Participants in both groups will be asked to report to the study site weekly for 6 months and then monthly for the final 3 months to provide an update on the status of their housing, healthcare providers, case managers, and HIV medications. Additional interviews about housing, income, use of health services, drug use, sexual practices, and mental health will occur at the beginning of the study and three more times throughout the study. Blood tests will be performed monthly to assess viral load, and every 3 months to assess CD4 count. Participants taking HIV medications will be visited by study staff at home once a month so that use of HIV medications can be determined. At the end of the study, participants in the control group may continue receiving treatment at the AHP. Six months after the end of the study, participants in the treatment group may also begin treatment with a psychiatrist at the AHP.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Participants receiving storefront directly observed therapy of anti-depressants (Fluoxetine)
Directly Observed Therapy (DOT)
DOT includes storefront directly observed therapy of prescribed anti-depressants. Participants will meet with a study psychiatrist, who will prescribe an appropriate antidepressant medication. Subsequent meetings with the psychiatrist will occur weekly for the first 3 weeks, and then monthly for the duration of the study. Additionally, participants will have DOT visits every weekday morning for 1 month to take their antidepressant medications. After the first month, DOT visits will occur weekly or biweekly, depending on the medication regimen.
Fluoxetine
Medication treatment includes flouxetine for treatment of depression.
Control
Participants receiving referral to mental health follow-up with the UCSF AIDS Health Project
No interventions assigned to this group
Interventions
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Directly Observed Therapy (DOT)
DOT includes storefront directly observed therapy of prescribed anti-depressants. Participants will meet with a study psychiatrist, who will prescribe an appropriate antidepressant medication. Subsequent meetings with the psychiatrist will occur weekly for the first 3 weeks, and then monthly for the duration of the study. Additionally, participants will have DOT visits every weekday morning for 1 month to take their antidepressant medications. After the first month, DOT visits will occur weekly or biweekly, depending on the medication regimen.
Fluoxetine
Medication treatment includes flouxetine for treatment of depression.
Eligibility Criteria
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Inclusion Criteria
* Score of greater than 13 on the Beck Depression Inventory (BDI)
* DSM-IV diagnosis of major depressive disorder, dysthymia, or minor depressive disorder
* Considered by the reviewing psychiatrist to benefit from antidepressant therapy
* Willing to take antidepressant medication or, if currently taking medication, willing to change medications if deemed appropriate
* Consents to coordinate with the primary medical provider
* Speaks English
Exclusion Criteria
* Current substance abuse disorder requiring immediate residential or inpatient treatment
* At risk for suicide
* Presence of signs and symptoms consistent with psychotic depression, as defined by DSM-IV, warranting immediate hospitalization
* Any condition or use of any medication that may make simultaneous use of antidepressant medication unsafe
* Currently prescribed antidepressant therapy and in psychiatric treatment (treated by a psychiatrist within 3 months prior to study entry)
* Pregnant
* Bipolar disorder
* Current psychotic disorder
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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David Bangsberg, MD
Principal Investigator
Principal Investigators
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David R. Bangsberg, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Market Street Study Site
San Francisco, California, United States
Countries
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References
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