Full Text View
Tabular View
No Study Results Posted
Related Studies
Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents
This study is ongoing, but not recruiting participants.
Study NCT00073424   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)
First Received: November 20, 2003   Last Updated: November 3, 2009   History of Changes

November 20, 2003
November 3, 2009
 
 
 
 
Complete list of historical versions of study NCT00073424 on ClinicalTrials.gov Archive Site
 
 
 
Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents
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).

 
Observational
Prospective
HIV Infections
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
200
 
 

Inclusion Criteria

  • HIV-1 perinatal infection
  • Already enrolled and in active follow-up in PACTG 219C
  • Can communicate in English or Spanish
  • On antiretroviral medication regimen at the time of enrollment, regardless of compliance with regimen, with no planned treatment interruptions

Exclusion Criteria

  • Acquired HIV via routes other than perinatal transmission or source of HIV infection is unknown
  • HIV-2 infection
Both
8 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00073424
 
PACTG P1042s
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Sharon Nichols, PhD Department of Neurosciences, University of California, San Diego
National Institute of Allergy and Infectious Diseases (NIAID)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP