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

31. maj 2013 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

HIV-infektioner

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år til 19 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

Studiestol: Sharon Nichols, PhD, Department of Neurosciences, University of California, San Diego

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2004

Studieafslutning (Faktiske)

1. oktober 2006

Datoer for studieregistrering

Først indsendt

20. november 2003

Først indsendt, der opfyldte QC-kriterier

20. november 2003

Først opslået (Skøn)

21. november 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2013

Sidst verificeret

1. maj 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Behandlingserfaren

Yderligere relevante MeSH-vilkår

Infektioner

Andre undersøgelses-id-numre

PACTG P1042s
10107 (Anden identifikator: CTEP)

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