Modified Directly Observed Therapy for Improving Antiretroviral Therapy Adherence in People With HIV

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. High rates of mental illness, substance use, and
unstable housing, however, make adherence to ART particularly problematic in poor urban
populations. Directly observed therapy (DOT), in which medication intake is closely
monitored, improved treatment adherence during the tuberculosis epidemic of the 1990s, and
is now gaining recognition as a model for improving ART adherence. HIV DOT has been
successfully delivered to people residing in structured living settings. The majority of
HIV-infected people, however, live outside these facilities. Therefore, there is a need for
a modified version of DOT to reach HIV-infected people in community settings. This study
will evaluate the effectiveness of a MDOT program in increasing ART adherence in poor,
HIV-infected residents of urban communities.

Participants in this open label study will be randomly assigned to either receive standard
care or participate in the MDOT program. Participants assigned to standard care will report
to the study site once a month for 9 months, but will not receive any assistance with taking
HIV medications. Information about medication adherence, housing, income, use of health
services, drug use, sexual practices, and mental health services will be collected at each
visit. Participants in the MDOT program will report to the study site each morning for 3
months, Monday through Friday, to take their HIV medication and any other medications
prescribed by their primary care doctors. 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. At the end of 3 months, participants will no longer attend the study site
for medication assistance. They will, however, participate in Action Point, a county program
that helps participants adhere to taking medication, for an additional 3 months.
Participants will also check in with the study staff once a month. Following this,
participants may choose to discontinue the Action Point program for the final 3 months of
the study. They will continue monthly check-in visits with the study staff. At each visit,
interviews will be conducted and medication adherence will be assessed. Blood tests will be
performed once every 3 months throughout the study.

Inclusion Criteria:

- HIV infected

- Severely immunosuppressed (HIV viral load of greater than 400 copies/ml)

- Does not consistently take prescribed ARV

- Currently prescribed HIV medications or prescribed to start taking HIV medications

Exclusion Criteria:

- Currently participating in any other adherence program or intervention study