Typology of Adherence in Adolescents: Phase II

HIV Infection Clinical Trial

Official title:

Typology of Adherence in Adolescents: Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106678
• Other study ID #: ATN 023B
• Status: Completed
• Phase: N/A
• First received: March 28, 2005
• Last updated: February 27, 2017
• Start date: June 2004
• Est. completion date: April 2005

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Locations

Country	Name	City	State
Puerto Rico	University Pediatric Hospital	San Juan
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland Medical School	Baltimore	Maryland
United States	Childrens Hospital Boston	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	Children's Diagnostic and Treatment Center	Fort Lauderdale	Florida
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Tulane University	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York City	New York
United States	Weill Medical College of Cornell University-New York Presbyterian Hospital	New York City	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California at San Diego	San Diego	California
United States	University of California at San Francisco	San Francisco	California
United States	University of South Florida	Tampa	Florida
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico,