This study will determine whether a managed problem solving intervention can help patients
with HIV better follow their anti-HIV drug regimen and can control HIV better than the
standard of care.
HAART is considered to be the most effective treatment for HIV. However, sustained and
consistent adherence to HAART is necessary for long-term success. Issues such as memory
problems, lack of social support, medication side effects, depression, and substance abuse
can significantly reduce patient adherence to HAART. This study will evaluate the
effectiveness of a managed problem solving strategy to increase HAART adherence in patients
with HIV. Both treatment-naive and treatment-experienced participants will be recruited for
The treatment part of this study will last 12 months. Participants will be randomly assigned
to receive the managed problem solving intervention or standard of care for 12 months.
Participants in the managed problem solving group will have 4 study visits and will receive
3 phone calls for the first 3 months of the study, and 1 phone call every month for the
following 9 months. At each study visit, participants will identify barriers to adherence.
During the phone calls, participants will be asked about any steps they have taken to
improve their adherence. A medication event monitoring system (MEMS) will be used to assess
participants' treatment adherence. MEMS uses microelectronic monitors on the caps of
medication bottles to record the timing and frequency of bottle openings. Participants whose
adherence has decreased or remained the same at the end of 12 months will be evaluated for
regimen changes. Blood collection at the beginning and end of the study will be used to
measure viral load and CD4 count. Follow-up phone interviews will be conducted every year
for 3 years after the end of treatment.
Study hypothesis: Managed problem solving will result in better adherence to highly active
antiretroviral therapy (HAART) and better virologic control and immunological outcomes at
the end of 1 year compared with a control group receiving standard or care.
Inclusion Criteria for All Participants:
- HIV infected
- Infection likely to be susceptible to a specific treatment regimen
- Have access to a telephone
- Willing and able to comply with all study requirements
Exclusion Criteria for All Participants:
- Live in a care facility that provides medications on schedule
Inclusion Criteria for Treatment-Experienced Participants:
- Restarting HAART after a treatment interruption of at least 3 months OR after
virologic failure with a viral load greater than 1,000 copies/ml
- On a treatment regimen for less than 2 weeks prior to study entry