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NCT00073424 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Cognitive, Behavioral, and Psychosocial Correlates of Medication Adherence in Children and Adolescents With HIV-1 Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00073424
Other study ID # PACTG P1042s
Secondary ID 10107
Status Completed
Phase N/A
First received November 20, 2003
Last updated May 31, 2013
Start date January 2004
Est. completion date October 2006

Study information
Verified date May 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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).

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 information / eligibility
Status Completed
Enrollment 200
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 19 Years
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
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
United States Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases Augusta Georgia
United States 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 UAB, Dept. of Ped., Div. of Infectious Diseases Birmingham Alabama
United States HMS - Children's Hosp. Boston, Div. of Infectious Diseases Boston Massachusetts
United States Bronx-Lebanon Hosp. IMPAACT CRS Bronx New York
United States Jacobi Med. Ctr. Bronx New York
United States SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS Brooklyn New York
United States UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases Chapel Hill North Carolina
United States Chicago Children's CRS Chicago Illinois
United States Univ. of Colorado Denver NICHD CRS Denver Colorado
United States DUMC Ped. CRS Durham North Carolina
United States South Florida CDTC Ft Lauderdale NICHD CRS Fort Lauderdale Florida
United States Texas Children's Hosp. CRS Houston Texas
United States Long Beach Memorial Med. Ctr., Miller Children's Hosp. Long Beach California
United States Usc La Nichd Crs Los Angeles California
United States St. Jude/UTHSC CRS Memphis Tennessee
United States Univ. of Miami Ped. Perinatal HIV/AIDS CRS Miami Florida
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 Harlem Hosp. Ctr. NY NICHD CRS New York New York
United States Nyu Ny Nichd Crs New York New York
United States NJ Med. School CRS Newark New Jersey
United States Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. Oakland California
United States St. Christopher's Hosp. for Children Philadelphia Pennsylvania
United States The Children's Hosp. of Philadelphia IMPAACT CRS Philadelphia Pennsylvania
United States Phoenix Children's Hosp. Phoenix Arizona
United States UCSD Mother-Child-Adolescent Program CRS San Diego California
United States UCSF Pediatric AIDS CRS San Francisco California
United States Baystate Medical Center, Springfield Springfield Massachusetts
United States SUNY Stony Brook NICHD CRS Stony Brook New York
United States SUNY Upstate Med. Univ., Dept. of Peds. Syracuse New York
United States Children's National Med. Ctr., ACTU Washington District of Columbia
United States Howard Univ. Washington DC NICHD CRS Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (6)

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. — View Citation

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 co — View Citation

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. — View Citation

Gordillo V, del Amo J, Soriano V, González-Lahoz J. Sociodemographic and psychological variables influencing adherence to antiretroviral therapy. AIDS. 1999 Sep 10;13(13):1763-9. — View Citation

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/jpe — View Citation

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. — View Citation

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