Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00073424
First received: November 20, 2003
Last updated: May 31, 2013
Last verified: May 2013
  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: Time Perspective: 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
Study Start Date: January 2004
Study Completion Date: October 2006
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix Children's Hosp.
Phoenix, Arizona, United States, 85006
United States, California
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
Usc La Nichd Crs
Los Angeles, California, United States, 90033
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609-1809
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 92103
UCSF Pediatric AIDS CRS
San Francisco, California, United States, 94143-0105
United States, Colorado
Univ. of Colorado Denver NICHD CRS
Denver, Colorado, United States, 80218-1088
United States, Connecticut
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Children's National Med. Ctr., ACTU
Washington, District of Columbia, United States, 20010
Howard Univ. Washington DC NICHD CRS
Washington, District of Columbia, United States, 20060
United States, Florida
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States, 33316
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33136
United States, Georgia
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia, United States, 30912
United States, Illinois
Chicago Children's CRS
Chicago, Illinois, United States, 60614
United States, Louisiana
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112-2699
United States, Maryland
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
Baystate Medical Center, Springfield
Springfield, Massachusetts, United States, 01199
United States, New Jersey
NJ Med. School CRS
Newark, New Jersey, United States, 07101-1709
United States, New York
Jacobi Med. Ctr.
Bronx, New York, United States, 10461
Bronx-Lebanon Hosp. IMPAACT CRS
Bronx, New York, United States, 10457
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States, 11203-2098
Nyu Ny Nichd Crs
New York, New York, United States, 10016
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States, 11794-8111
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
United States, North Carolina
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, United States, 27599-7220
DUMC Ped. CRS
Durham, North Carolina, United States, 27705
United States, Pennsylvania
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States, 19134
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 19104-4318
United States, Tennessee
St. Jude/UTHSC CRS
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
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:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00073424     History of Changes
Other Study ID Numbers: PACTG P1042s, 10107
Study First Received: November 20, 2003
Last Updated: May 31, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 21, 2014