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Typology of Adherence in Adolescents: Phase II

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ClinicalTrials.gov Identifier: NCT00106678
Recruitment Status : Completed
First Posted : March 29, 2005
Last Update Posted : March 1, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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.

Condition or disease
HIV Infection

Detailed Description:

As more HIV-infected adolescents are identified and linked into care, the dyad of medication and medication adherence continues to be an issue for both the provider and the patients. Thus, developing a strategy to assess adherence and barriers to adherence in this population is integral so that interventions can be targeted towards adolescents' specific needs. Our operating premise is that the issue of drug adherence is multi-factorial and that interventions that combine a variety of modalities may be preferred. However, before such interventions can be developed, we must first develop a tool that can be used to assess medication adherence and to identify barriers to medication adherence in this population.

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.


Study Design
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Study Type : Observational
Actual Enrollment : 1200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Typology of Adherence in Adolescents: Phase II
Study Start Date : June 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Infected through risk behaviors
Infected perinatally or through blood/blood products.


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106678


Locations
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
University of California at San Diego
San Diego, California, United States, 92103
University of California at San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States, 33316
University of Miami
Miami, Florida, United States, 33101
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Medical School
Baltimore, Maryland, United States, 21204
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Childrens Hospital Boston
Boston, Massachusetts, United States, 02115
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Weill Medical College of Cornell University-New York Presbyterian Hospital
New York City, New York, United States, 10021
Mount Sinai Hospital
New York City, New York, United States, 10128
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Study Chair: Bret Rudy, MD Children's Hospital of Philadelphia
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00106678     History of Changes
Other Study ID Numbers: ATN 023B
First Posted: March 29, 2005    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2016

Keywords provided by University of North Carolina, Chapel Hill:
HIV
Antiretroviral therapy (ART)
HAART
Adherence
Barriers

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases