HIV Infections Clinical Trial
Official title:
Cognitive, Behavioral, and Psychosocial Correlates of Medication Adherence in Children and Adolescents With HIV-1 Infection
Taking anti-HIV medication consistently and properly is a critical issue for patients with HIV. Drug regimens are complex; when regimens are not taken properly, HIV can become resistant to the drugs. Taking anti-HIV medication properly leads to improved health. Children and adolescents with HIV face unique challenges to taking HIV medication properly. This study will look at the relationship between how children cope with the responsibility for taking medication and the child's language, memory, attention, behavior, and academic skills. This study is open to children and adolescents who are currently enrolled in the PACTG 219C study (Long-Term Effects of HIV Exposure and Infection in Children).
Medication adherence is a critical issue for HIV infected children and adolescents because
of drug resistance and the increased complexity of treatment regimens. Children and
adolescents with HIV face depression, anxiety, denial, and rebellion that may interfere with
their motivation to take medication. Depression and self-perceived social support have been
found to predict regimen adherence in adults with HIV. Children with other chronic diseases
are less likely to adhere to their medication regimens if they also have behavioral or
emotional problems; assessing emotional and behavioral function in children and adolescents
with HIV may help in predicting adherence and explaining adherence failure. This study will
correlate cognitive, behavioral, and psychosocial functioning with measures of virologic
suppression and immunological status, and it will compare self-report and pill count
measures of adherence in a randomly selected subset of perinatally infected HIV participants
of PACTG 219C.
Children and adolescents currently enrolled in PACTG 219C will be randomly selected for this
study, which will last for 48 weeks. At entry, participants will undergo neuropsychological
evaluation, including academic achievement, attention, memory, language comprehension, and
behavior assessments, and complete a health beliefs questionnaire. Both the participants and
their parents or primary caregivers will complete questionnaires at study entry and Weeks 24
and 48. Adherence will be evaluated from self-reported and pill count measures (Weeks 4 and
24) and the PACTG 219C Adherence Module (Weeks 24 and 48).
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