HIV Infections Clinical Trial
Official title:
Managed Problem Solving: An HIV Adherence Trial
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
this study.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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