Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents
31 maggio 2013 aggiornato da: National Institute of Allergy and Infectious Diseases (NIAID)
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).
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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).
Tipo di studio
Osservativo
Iscrizione
200
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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San Juan, Porto Rico
- San Juan City Hosp. PR NICHD CRS
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San Juan, Porto Rico, 00936-5067
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- UAB, Dept. of Ped., Div. of Infectious Diseases
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006
- Phoenix Children's Hosp.
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California
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Long Beach, California, Stati Uniti, 90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
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Los Angeles, California, Stati Uniti, 90033
- Usc La Nichd Crs
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Oakland, California, Stati Uniti, 94609-1809
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
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San Diego, California, Stati Uniti, 92103
- UCSD Mother-Child-Adolescent Program CRS
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San Francisco, California, Stati Uniti, 94143-0105
- UCSF Pediatric AIDS CRS
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Colorado
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Denver, Colorado, Stati Uniti, 80218-1088
- Univ. of Colorado Denver NICHD CRS
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06504
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20010
- Children's National Med. Ctr., ACTU
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Washington, District of Columbia, Stati Uniti, 20060
- Howard Univ. Washington DC NICHD CRS
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Florida
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Fort Lauderdale, Florida, Stati Uniti, 33316
- South Florida CDTC Ft Lauderdale NICHD CRS
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Miami, Florida, Stati Uniti, 33136
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
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Georgia
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Augusta, Georgia, Stati Uniti, 30912
- Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
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Illinois
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Chicago, Illinois, Stati Uniti, 60614
- Chicago Children's CRS
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112-2699
- Tulane/LSU Maternal/Child CRS
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
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Baltimore, Maryland, Stati Uniti
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
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Springfield, Massachusetts, Stati Uniti, 01199
- Baystate Medical Center, Springfield
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New Jersey
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Newark, New Jersey, Stati Uniti, 07101-1709
- NJ Med. School CRS
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New York
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Bronx, New York, Stati Uniti, 10457
- Bronx-Lebanon Hosp. IMPAACT CRS
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Bronx, New York, Stati Uniti, 10461
- Jacobi Med. Ctr.
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Brooklyn, New York, Stati Uniti, 11203-2098
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
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New York, New York, Stati Uniti, 10016
- Nyu Ny Nichd Crs
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New York, New York, Stati Uniti, 10037
- Harlem Hosp. Ctr. NY NICHD CRS
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Stony Brook, New York, Stati Uniti, 11794-8111
- SUNY Stony Brook NICHD CRS
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Syracuse, New York, Stati Uniti, 13210
- SUNY Upstate Med. Univ., Dept. of Peds.
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599-7220
- UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
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Durham, North Carolina, Stati Uniti, 27705
- DUMC Ped. CRS
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19134
- St. Christopher's Hosp. for Children
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Philadelphia, Pennsylvania, Stati Uniti, 19104-4318
- The Children's Hosp. of Philadelphia IMPAACT CRS
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Tennessee
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Memphis, Tennessee, Stati Uniti, 38105-2794
- St. Jude/UTHSC CRS
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Texas
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Houston, Texas, Stati Uniti, 77030
- Texas Children's Hosp. CRS
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 8 anni a 19 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Cattedra di studio: Sharon Nichols, PhD, Department of Neurosciences, University of California, San Diego
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2004
Completamento dello studio (Effettivo)
1 ottobre 2006
Date di iscrizione allo studio
Primo inviato
20 novembre 2003
Primo inviato che soddisfa i criteri di controllo qualità
20 novembre 2003
Primo Inserito (Stima)
21 novembre 2003
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
3 giugno 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 maggio 2013
Ultimo verificato
1 maggio 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PACTG P1042s
- 10107 (Altro identificatore: CTEP)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .