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



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

For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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).
Details: 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 adolecents 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:
Study Type:
  Observational, Psychosocial, Cross-Sectional, Defined Population, Prospective Study
Minimum Age/Maximum Age: 8 Years/19 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 200

Location and Contact Information:

Overall Study Official:
SharonNichols,  Study Chair,  Department of Neurosciences, University of California, San Diego

University of Alabama at Birmingham (Pediatric) *Not yet recruiting*
Birmingham,  Alabama,  35233
United States
Not yet recruiting Terry  Byars 205-558-2328

University of Florida, Gainsville *Not yet recruiting*
Gainesville,  Florida,  32610-0296
United States
Not yet recruiting Carol  Delany 352-846-3598

Jacobi Medical Center *Not yet recruiting*
Bronx,  New York,  10461
United States
Not yet recruiting Wanda  Biernick 718-918-4903

Childrens Hospital, Oakland (Pediatric) *Recruiting*
Oakland,  California,  94609-1809
United States
Recruiting Teresa  Courville 510-428-3885

Johns Hopkins University (Pediatric) *Recruiting*
Baltimore,  Maryland, 
United States
Recruiting Mary  Griffith 410-955-9749

UCSD Mother, Child & Adolescent HIV Program *Not yet recruiting*
San Diego,  California,  92103
United States
Not yet recruiting Linda  Proctor 619-543-8080

San Juan City Hospital *Recruiting*
San Juan,  , 
Puerto Rico
Recruiting Maria  Pilar Thurin 787-765-4186

North Broward Hospital District *Recruiting*
Ft. Lauderdale,  Florida,  33316
United States
Recruiting Amy  Inman 954-728-1050

Duke University (Pediatric) *Not yet recruiting*
Durham,  North Carolina,  27705
United States
Not yet recruiting John  Swetnam 919-416-3447

St. Christophers Hosp. for Children, Philadelphia *Recruiting*
Philadelphia,  Pennsylvania,  19134
United States
Recruiting Janet  Chen 215-427-5284

Medical College of Georgia *Not yet recruiting*
Augusta,  Georgia,  30912
United States
Not yet recruiting Susan  Cobb 706-721-2437

Chicago Childrens Memorial Hospital (Pediatrics) *Recruiting*
Chicago,  Illinois,  60614
United States
Recruiting Stacy  Rogers 773-880-3669

University of Puerto Rico, U. Childrens Hospital AIDS *Not yet recruiting*
San Juan,  ,  00936-5067
Puerto Rico
Not yet recruiting Sylvia  Davila Nieves 787-759-9595

St. Jude Children's Research Hospital, Memphis *Not yet recruiting*
Memphis,  Tennessee,  38105-2794
United States
Not yet recruiting Laura  Utech 901-495-3490

Childrens Hospital of Boston *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting Kirk  Bertelsen 617-355-8198

Baystate Medical Center, Springfield *Recruiting*
Springfield,  Massachusetts,  01199
United States
Recruiting MariPat  Toye 413-794-5399

Long Beach Memorial (Pediatric) *Not yet recruiting*
Long Beach,  California,  90801
United States
Not yet recruiting Susan  Marks 532-933-8590

University of Miami (Pediatric) *Not yet recruiting*
Miami,  Florida,  33136
United States
Not yet recruiting Cathie  Gamber 305-243-4446

University of North Carolina at Chapel Hill *Not yet recruiting*
Chapel Hill,  North Carolina,  27599-7220
United States
Not yet recruiting Elizabeth  Pitkin 919-966-9110

Baylor (Texas Childrens Hospital)(Pediatric) *Not yet recruiting*
Houston,  Texas,  77030
United States
Not yet recruiting Chivon  Jackson 832-824-1339

Childrens National Medical Center *Not yet recruiting*
Washington D.C.,  District of Columbia,  20010
United States
Not yet recruiting Veronica  Amos 202-884-2837

New York University School of Medicine *Not yet recruiting*
New York City,  New York,  10016
United States
Not yet recruiting Nagamah  Deygoo 212-263-5680

Los Angeles County Medical Center/USC *Not yet recruiting*
Los Angeles,  California,  90033
United States
Not yet recruiting Eva  Operskalski 323-226-2226


Additional Information:
Study ID Numbers:
  PACTG P1042s; 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073424

Other Hiv Infections Studies:
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2. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Have Not Had Success with Ganciclovir

3. A Study of Viracept in AIDS Patients with Mycobacterium Avium Complex Disease (MAC)

4. A Study of PMPA in HIV-Infected Patients

5. A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients

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