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).

Study Overview

• Status: Completed
• Conditions: HIV Infections

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).

• Study Type: Observational
• Enrollment: 200

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico
    • San Juan City Hosp. PR NICHD CRS
  • San Juan, Puerto Rico, 00936-5067
    • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB, Dept. of Ped., Div. of Infectious Diseases
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Phoenix Children's Hosp.
  • California
    • Long Beach, California, United States, 90801
      • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
    • Los Angeles, California, United States, 90033
      • Usc La Nichd Crs
    • Oakland, California, United States, 94609-1809
      • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
    • San Diego, California, United States, 92103
      • UCSD Mother-Child-Adolescent Program CRS
    • San Francisco, California, United States, 94143-0105
      • UCSF Pediatric AIDS CRS
  • Colorado
    • Denver, Colorado, United States, 80218-1088
      • Univ. of Colorado Denver NICHD CRS
  • Connecticut
    • New Haven, Connecticut, United States, 06504
      • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Med. Ctr., ACTU
    • Washington, District of Columbia, United States, 20060
      • Howard Univ. Washington DC NICHD CRS
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • South Florida CDTC Ft Lauderdale NICHD CRS
    • Miami, Florida, United States, 33136
      • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Chicago Children's CRS
  • Louisiana
    • New Orleans, Louisiana, United States, 70112-2699
      • Tulane/LSU Maternal/Child CRS
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
    • Baltimore, Maryland, United States
      • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center, Springfield
  • New Jersey
    • Newark, New Jersey, United States, 07101-1709
      • NJ Med. School CRS
  • New York
    • Bronx, New York, United States, 10457
      • Bronx-Lebanon Hosp. IMPAACT CRS
    • Bronx, New York, United States, 10461
      • Jacobi Med. Ctr.
    • Brooklyn, New York, United States, 11203-2098
      • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
    • New York, New York, United States, 10016
      • Nyu Ny Nichd Crs
    • New York, New York, United States, 10037
      • Harlem Hosp. Ctr. NY NICHD CRS
    • Stony Brook, New York, United States, 11794-8111
      • SUNY Stony Brook NICHD CRS
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Med. Univ., Dept. of Peds.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7220
      • UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
    • Durham, North Carolina, United States, 27705
      • DUMC Ped. CRS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • St. Christopher's Hosp. for Children
    • Philadelphia, Pennsylvania, United States, 19104-4318
      • The Children's Hosp. of Philadelphia IMPAACT CRS
  • Tennessee
    • Memphis, Tennessee, United States, 38105-2794
      • St. Jude/UTHSC CRS
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hosp. CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Study Chair: Sharon Nichols, PhD, Department of Neurosciences, University of California, San Diego

Publications and helpful links

General Publications

• Catz SL, Kelly JA, Bogart LM, Benotsch EG, McAuliffe TL. Patterns, correlates, and barriers to medication adherence among persons prescribed new treatments for HIV disease. Health Psychol. 2000 Mar;19(2):124-33.
• Gaughan DM, Hughes MD, Oleske JM, Malee K, Gore CA, Nachman S; Pediatric AIDS Clinical Trials Group 219C Team. Psychiatric hospitalizations among children and youths with human immunodeficiency virus infection. Pediatrics. 2004 Jun;113(6):e544-51. doi: 10.1542/peds.113.6.e544.
• Gordillo V, del Amo J, Soriano V, Gonzalez-Lahoz J. Sociodemographic and psychological variables influencing adherence to antiretroviral therapy. AIDS. 1999 Sep 10;13(13):1763-9. doi: 10.1097/00002030-199909100-00021.
• Rogers AS, Miller S, Murphy DA, Tanney M, Fortune T. The TREAT (Therapeutic Regimens Enhancing Adherence in Teens) program: theory and preliminary results. J Adolesc Health. 2001 Sep;29(3 Suppl):30-8. doi: 10.1016/s1054-139x(01)00289-0. No abstract available.
• Farley JJ, Montepiedra G, Storm D, Sirois PA, Malee K, Garvie P, Kammerer B, Naar-King S, Nichols S; PACTG P1042S Team. Assessment of adherence to antiretroviral therapy in perinatally HIV-infected children and youth using self-report measures and pill count. J Dev Behav Pediatr. 2008 Oct;29(5):377-84. doi: 10.1097/DBP.0b013e3181856d22.
• Naar-King S, Montepiedra G, Nichols S, Farley J, Garvie PA, Kammerer B, Malee K, Sirois PA, Storm D; PACTG P1042S Team. Allocation of family responsibility for illness management in pediatric HIV. J Pediatr Psychol. 2009 Mar;34(2):187-94. doi: 10.1093/jpepsy/jsn065. Epub 2008 Jun 27.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: November 20, 2003
• First Submitted That Met QC Criteria: November 20, 2003
• First Posted (Estimate): November 21, 2003

Study Record Updates

• Last Update Posted (Estimate): June 3, 2013
• Last Update Submitted That Met QC Criteria: May 31, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Treatment Experienced
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: PACTG P1042s; 10107 (Other Identifier: CTEP)