Typology of Adherence in Adolescents: Phase II

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00106678
First received: March 28, 2005
Last updated: June 23, 2014
Last verified: April 2014

March 28, 2005
June 23, 2014
June 2004
April 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00106678 on ClinicalTrials.gov Archive Site
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Typology of Adherence in Adolescents: Phase II
Typology of Adherence in Adolescents: Phase II

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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.

HIV Infection
Not Provided
  • Infected through risk behaviors
  • Infected perinatally or through blood/blood products.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
April 2005
April 2005   (final data collection date for primary outcome measure)

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
Both
12 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00106678
ATN 023B
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Chair: Bret Rudy, MD Children's Hospital of Philadelphia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP