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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00073424 |
Purpose
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).
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Cognitive, Behavioral, and Psychosocial Correlates of Medication Adherence in Children and Adolescents With HIV-1 Infection |
| Estimated Enrollment: | 200 |
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).
Eligibility| Ages Eligible for Study: | 8 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama at Birmingham (Pediatric) | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Phoenix Childrens Hospital | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Long Beach Memorial (Pediatric) | |
| Long Beach, California, United States, 90801 | |
| UCSD Mother, Child & Adolescent HIV Program | |
| San Diego, California, United States, 92103 | |
| Los Angeles County Medical Center/USC | |
| Los Angeles, California, United States, 90033 | |
| Childrens Hospital, Oakland (Pediatric) | |
| Oakland, California, United States, 94609-1809 | |
| UCSF, Moffitt Hospital (Pediatric) | |
| San Francisco, California, United States, 94143-0105 | |
| United States, Colorado | |
| Childrens Hospital (U. Colorado, Denver) | |
| Denver, Colorado, United States, 80218-1088 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| Childrens National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| Howard University Hospital | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| North Broward Hospital District | |
| Fort Lauderdale, Florida, United States, 33316 | |
| University of Miami (Pediatric) | |
| Miami, Florida, United States, 33136 | |
| University of Florida, Gainsville | |
| Gainsville, Florida, United States, 32610-0296 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Chicago Childrens Memorial Hospital (Pediatrics) | |
| Chicago, Illinois, United States, 60614 | |
| University of Illinois | |
| Chicago, Illinois, United States, 60612-7234 | |
| United States, Louisiana | |
| Tulane Univ., Charity Hospital of New Orleans | |
| New Orleans, Louisiana, United States, 70112-2699 | |
| United States, Maryland | |
| Johns Hopkins University (Pediatric) | |
| Baltimore, Maryland, United States | |
| University of Maryland (Pediatric) | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Baystate Medical Center, Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| Childrens Hospital of Boston | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New Jersey | |
| Univ. of Med. & Dentistry of NJ/Univ. Hospital | |
| Newark, New Jersey, United States, 07101-1709 | |
| United States, New York | |
| Jacobi Medical Center | |
| Bronx, New York, United States, 10461 | |
| New York University School of Medicine | |
| New York, New York, United States, 10016 | |
| Children's Hospital at Downstate | |
| Brooklyn, New York, United States, 11203-2098 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642-0001 | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Harlem Hospital | |
| New York, New York, United States, 10037 | |
| State University of New York at Stony Brook | |
| Stony Brook, New York, United States, 11794-8111 | |
| Bronx Lebanon Hospital Center | |
| Bronx, New York, United States, 10457 | |
| The Columbia Presbyterian Medical Center | |
| New York, New York, United States | |
| United States, North Carolina | |
| Duke University (Pediatric) | |
| Durham, North Carolina, United States, 27705 | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7220 | |
| United States, Pennsylvania | |
| St. Christophers Hosp. for Children, Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19134 | |
| Childrens Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-4318 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital, Memphis | |
| Memphis, Tennessee, United States, 38105-2794 | |
| United States, Texas | |
| Baylor (Texas Childrens Hospital)(Pediatric) | |
| Houston, Texas, United States, 77030 | |
| Puerto Rico | |
| San Juan City Hospital | |
| San Juan, Puerto Rico | |
| University of Puerto Rico, U. Childrens Hospital AIDS | |
| San Juan, Puerto Rico, 00936-5067 | |
| Study Chair: | Sharon Nichols, PhD | Department of Neurosciences, University of California, San Diego |
More Information
| Study ID Numbers: | PACTG P1042s |
| Study First Received: | November 20, 2003 |
| Last Updated: | November 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00073424 History of Changes |
| Health Authority: | United States: Federal Government |
|
Treatment Experienced |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |