Typology of Adherence in Adolescents: Phase II
1 other identifier
observational
1,200
2 countries
17
Brief Summary
A number of factors influence HIV-positive adolescents' acceptance of and willingness to continue taking anti-HIV medicines. These factors include mental health and substance abuse issues, barriers such as lack of medical insurance, and cognitive-behavioral barriers (such as a person's impression of the impact of the medicines on his/her health and a person's sense of his/her ability to continue taking the medications prescribed). The purpose of this study is to use a survey to determine how common specific barriers are that prevent HIV positive adolescents from taking their anti-HIV medicines and if those barriers cluster together. The information collected will be used to develop and validate a schema for classifying HIV medication adherence by barriers to adherence or clusters of barriers to adherence. This classification schema could then be used in the development of interventions that better meet the needs of HIV-infected youth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2004
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 28, 2005
CompletedFirst Posted
Study publicly available on registry
March 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedMarch 1, 2017
February 1, 2016
10 months
March 28, 2005
February 27, 2017
Conditions
Keywords
Study Arms (2)
Infected through risk behaviors
Infected perinatally or through blood/blood products.
Eligibility Criteria
The study population will consist of HIV-infected youth who are eligible for antiretroviral therapy (ART) based on the US Public Health Service (PHS) guidelines and have been offered and/or prescribed HAART by their healthcare provider. Subjects aged 12 through 24 years old will be recruited from youth engaged in care at the fifteen ATN clinical sites located across the United States and in Puerto Rico. Youth engaged in care at selected non- ATN clinic centers will also be offered the opportunity to participate in this study.
You may qualify if:
- Between the ages of 12 years and 24 years
- 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
You may not qualify if:
- Infected with HIV but do not require ART
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California at San Diego
San Diego, California, 92103, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316, United States
University of Miami
Miami, Florida, 33101, United States
University of South Florida
Tampa, Florida, 33606, United States
Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
Tulane University
New Orleans, Louisiana, 70112, United States
University of Maryland Medical School
Baltimore, Maryland, 21204, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21224, United States
Childrens Hospital Boston
Boston, Massachusetts, 02115, United States
Weill Medical College of Cornell University-New York Presbyterian Hospital
New York, New York, 10021, United States
Mount Sinai Hospital
New York, New York, 10128, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University Pediatric Hospital
San Juan, 00936, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bret Rudy, MD
Children's Hospital of Philadelphia
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2005
First Posted
March 29, 2005
Study Start
June 1, 2004
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
March 1, 2017
Record last verified: 2016-02