Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents
- Conditions
- HIV Infections
- Registration Number
- NCT00073424
- 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 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).
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Usc La Nichd Crs
🇺🇸Los Angeles, California, United States
South Florida CDTC Ft Lauderdale NICHD CRS
🇺🇸Fort Lauderdale, Florida, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Baltimore, Maryland, United States
St. Christopher's Hosp. for Children
🇺🇸Philadelphia, Pennsylvania, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
🇺🇸Philadelphia, Pennsylvania, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
UCSD Mother-Child-Adolescent Program CRS
🇺🇸San Diego, California, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
UCSF Pediatric AIDS CRS
🇺🇸San Francisco, California, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, California, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
🇺🇸Brooklyn, New York, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
NJ Med. School CRS
🇺🇸Newark, New Jersey, United States
Baystate Medical Center, Springfield
🇺🇸Springfield, Massachusetts, United States
Texas Children's Hosp. CRS
🇺🇸Houston, Texas, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
Jacobi Med. Ctr.
🇺🇸Bronx, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
🇺🇸New York, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
🇺🇸Syracuse, New York, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
UAB, Dept. of Ped., Div. of Infectious Diseases
🇺🇸Birmingham, Alabama, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Denver, Colorado, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
🇺🇸Oakland, California, United States
Children's National Med. Ctr., ACTU
🇺🇸Washington, District of Columbia, United States
Howard Univ. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
🇺🇸Baltimore, Maryland, United States
Nyu Ny Nichd Crs
🇺🇸New York, New York, United States
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
🇺🇸Augusta, Georgia, United States
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Phoenix Children's Hosp.
🇺🇸Phoenix, Arizona, United States
St. Jude/UTHSC CRS
🇺🇸Memphis, Tennessee, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
🇺🇸New Haven, Connecticut, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
🇺🇸Chapel Hill, North Carolina, United States