Antidepressant Medication Plus Directly Observed Therapy for Improving Adherence to Antiretroviral Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Bangsberg, MD, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00338767
First received: June 16, 2006
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

This study will evaluate the effectiveness of directly observed therapy plus antidepressant medication in improving adherence to antiretroviral drug therapy among HIV-infected homeless and marginally housed people with depression.


Condition Intervention Phase
HIV Infections
Depression
Behavioral: Directly Observed Therapy (DOT)
Drug: Fluoxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Depression Treatment to Improve Antiretroviral Adherence

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Improved depression scores [ Time Frame: Measured at the end of 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV viral load [ Time Frame: Measured monthly for 9 months ] [ Designated as safety issue: No ]
  • CD4 Count [ Time Frame: Measured at baseline and Months 3, 6, and 9 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: January 2001
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Participants receiving storefront directly observed therapy of anti-depressants (Fluoxetine)
Behavioral: 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.
Drug: Fluoxetine
Medication treatment includes flouxetine for treatment of depression.
No Intervention: Control
Participants receiving referral to mental health follow-up with the UCSF AIDS Health Project

Detailed Description:

Antiretroviral drug therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A 95% adherence rate to ART is required to adequately suppress the virus and prevent transmission. Low ART adherence rates are often linked to depression, which is especially common in HIV-infected homeless or marginally housed people. In these cases, treatment with antidepressant medication may be useful in improving ART adherence. Directly Observed Therapy (DOT), in which medication intake is closely monitored, is another method of enhancing treatment compliance. DOT improved treatment adherence during the tuberculosis epidemic of the 1990s, and is now gaining recognition as a model for improving ART adherence. This study will evaluate the effectiveness of combining DOT and antidepressant medication in improving ART adherence among HIV-infected homeless and marginally housed people with depression.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Homeless or marginally housed
  • 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:

  • Signs and symptoms consistent with diagnosis of dementia, as defined by DSM-IV
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338767

Locations
United States, California
UCSF Market Street Study Site
San Francisco, California, United States, 94102
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David R. Bangsberg, MD, MPH University of California, San Francisco
  More Information

No publications provided

Responsible Party: David Bangsberg, MD, Principal Investigator, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00338767     History of Changes
Other Study ID Numbers: R01 MH63011, R01MH063011
Study First Received: June 16, 2006
Last Updated: November 13, 2013
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
AIDS
DOT
Directly Observed Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
HIV Infections
Acquired Immunodeficiency Syndrome
Behavioral Symptoms
Mood Disorders
Mental Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antidepressive Agents
Fluoxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on September 29, 2014