Typology of Adherence in Adolescents: Phase II

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT00106678

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), National Institute of Mental Health (NIMH) (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

1,200

Enrollment

Locations

Duration (Months)

70.6

Patients Per Site

7.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

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 :

Jun 1, 2004

Actual Primary Completion Date :

Apr 1, 2005

Actual Study Completion Date :

Apr 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Infected through risk behaviors
Infected perinatally or through blood/blood products.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Los Angeles	Los Angeles	California	United States	90027
2	University of California at San Diego	San Diego	California	United States	92103
3	University of California at San Francisco	San Francisco	California	United States	94143
4	Children's National Medical Center	Washington	District of Columbia	United States	20010
5	Children's Diagnostic and Treatment Center	Fort Lauderdale	Florida	United States	33316
6	University of Miami	Miami	Florida	United States	33101
7	University of South Florida	Tampa	Florida	United States	33606
8	Stroger Hospital of Cook County	Chicago	Illinois	United States	60612
9	Tulane University	New Orleans	Louisiana	United States	70112
10	University of Maryland Medical School	Baltimore	Maryland	United States	21204
11	Johns Hopkins Hospital	Baltimore	Maryland	United States	21224
12	Childrens Hospital Boston	Boston	Massachusetts	United States	02115
13	Montefiore Medical Center	Bronx	New York	United States	10467
14	Weill Medical College of Cornell University-New York Presbyterian Hospital	New York City	New York	United States	10021
15	Mount Sinai Hospital	New York City	New York	United States	10128
16	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
17	University Pediatric Hospital	San Juan		Puerto Rico	00936