Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106678
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2005-03-28
Brief Title:
Typology of Adherence in Adolescents Phase II
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Typology of Adherence in Adolescents Phase II
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons impression of the impact of the medicines on hisher health and a persons sense of hisher 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
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 subjects adherence to hisher 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 patients 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
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 subjects adherence to hisher 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None