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Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents
This study is ongoing, but not recruiting participants.
First Received: November 20, 2003   Last Updated: November 3, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 200
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).

  Eligibility

Ages Eligible for Study:   8 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073424

  Hide Study Locations
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
Sponsors and Collaborators
Investigators
Study Chair: Sharon Nichols, PhD Department of Neurosciences, University of California, San Diego
  More Information

Additional Information:
Publications:
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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 25, 2009