Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1200 participants
OBSERVATIONAL
2004-06-30
2005-04-30
Brief Summary
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Detailed Description
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This is a cross-sectional survey designed to assess the most prevalent combination of barriers to HIV medication adherence in adolescents. Specific barriers focused on in this study include mental health disorders, substance abuse, and cognitive-behavioral and structural barriers. In this Phase II study, the Adherence Staging Algorithm and the Participant Assessment Tool, pilot tested and modified based on findings from Phase I of the study, will be used to determine the prevalence of the specific barriers to adherence among HIV-infected youth requiring antiretroviral medication and the most common clusters of specific barriers. A cognitive-behavioral barriers schema for classifying HIV medication adherence in adolescents will be developed and validated.
The study consists of a one-time visit with a face-to-face interview to complete two questionnaires: the Adherence Staging Algorithm to classify the subject's adherence to his/her prescribed medications, and the Participant Assessment Tool to assess the prevalence of barriers to adherence that the subjects may have experienced. The interview takes no more than 30 minutes. In addition, the patient's medical record will be reviewed for HIV-related clinical data such as viral load, CD4, history of medications prescribed, and barriers the patient may have experienced such as mental health or substance abuse problems.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Infected through risk behaviors
No interventions assigned to this group
Infected perinatally or through blood/blood products.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Eligible for ART (antiretroviral therapy) based on US Public Health Service guidelines
* Have been offered and/or prescribed HAART (highly active antiretroviral therapy)
* Ability to give informed consent or assent with parental permission, where required
Exclusion Criteria
* Started HAART but stopped due to medical reasons, (e.g., change in medication guidelines, toxicity, resistance, etc.)
* Females prescribed/receiving HAART for the purpose of preventing mother-to-child transmission
12 Years
24 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Bret Rudy, MD
Role: STUDY_CHAIR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
University of California at San Diego
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Stroger Hospital of Cook County
Chicago, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
University of Maryland Medical School
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Childrens Hospital Boston
Boston, Massachusetts, United States
Weill Medical College of Cornell University-New York Presbyterian Hospital
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University Pediatric Hospital
San Juan, , Puerto Rico
Countries
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Other Identifiers
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ATN 023B
Identifier Type: -
Identifier Source: org_study_id
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