Clinical trial NCT00106678: Typology of Adherence in Adolescents: Phase II
Official title: Typology of Adherence in Adolescents: Phase II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
Antiretroviral therapy (ART)
HAART
Adherence
Barriers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-03-29
Enrollment: 1200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Children's Diagnostic and Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical School
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Childrens Hospital Boston
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York City
country: United States
facility: Weill Medical College of Cornell University-New York Presbyterian Hospital
state: New York
city: New York City
country: United States
facility: Mount Sinai Hospital
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Bret Rudy, MD
role: STUDY_CHAIR
References: