HIV Infections Clinical Trial
Official title:
Quality of Life and Healthcare Utilization Substudy
The purpose of this study is to compare the effects of two different anti-HIV drug regimens on quality of life and health care utilization among SMART study participants.
Advances in antiretroviral therapy (ART) have dramatically reduced mortality and morbidity
rates for HIV infected people. However, HIV infection is a costly disease to treat. With
improvement in survival, quality of life and the long-term cost of HIV treatment have become
increasingly important to the majority of individuals infected with HIV. Different HIV
treatment regimens may lead to variations in quality of life and health care costs over the
course of treatment. In the SMART study, participants were randomly assigned to one of two
treatment groups:
- Group 1 participants followed a drug conservation (DC) regimen in which ART was stopped
or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell
count was at least 350 cells/mm3, and then followed by episodic ART based on CD4 cell
count.
- Group 2 participants followed a viral suppression (VS) regimen in which ART was
continued to keep viral loads as low as possible, regardless of CD4 cell count.
The purpose of this study is to compare how the DC and VS regimens affect quality of life,
symptom severity, health care utilization, and resulting costs among SMART study
participants.
At baseline, participants will complete questionnaires regarding quality of life, symptoms,
health care utilization, current insurance, and socioeconomic status. Body appearance and
signs of HIV disease progression will also be assessed at this time. Follow-up evaluations
on quality of life and symptoms will be repeated at Months 4, 8, and 12 and annually
thereafter. Follow-up evaluations of all other baseline measures will occur once a year.
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Observational Model: Cohort, Time Perspective: Prospective
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