Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073424
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2003-11-20
Brief Title:
Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Cognitive Behavioral and Psychosocial Correlates of Medication Adherence in Children and Adolescents With HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childs 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10107 | REGISTRY | DAIDS ES | None |