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
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||1200 participants|
|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|
|Infected through risk behaviors|
|Infected perinatally or through blood/blood products.|
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
|Study Chair:||Bret Rudy, MD||Children's Hospital of Philadelphia|