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

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.

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