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

November 13, 2013 updated by: David Bangsberg, MD, Massachusetts General Hospital

Depression Treatment to Improve Antiretroviral Adherence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • UCSF Market Street Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improved depression scores
Time Frame: Measured at the end of 9 months
Measured at the end of 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HIV viral load
Time Frame: Measured monthly for 9 months
Measured monthly for 9 months
CD4 Count
Time Frame: Measured at baseline and Months 3, 6, and 9
Measured at baseline and Months 3, 6, and 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: David R. Bangsberg, MD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

June 16, 2006

First Submitted That Met QC Criteria

June 16, 2006

First Posted (Estimate)

June 20, 2006

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH063011 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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