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
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Condition or disease |
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HIV Infection |
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 |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
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 |

Group/Cohort |
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Infected through risk behaviors |
Infected perinatally or through blood/blood products. |

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Ages Eligible for Study: | 12 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
United States, California | |
Children's Hospital of Los Angeles | |
Los Angeles, California, United States, 90027 | |
University of California at San Diego | |
San Diego, California, United States, 92103 | |
University of California at San Francisco | |
San Francisco, California, United States, 94143 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
Children's Diagnostic and Treatment Center | |
Fort Lauderdale, Florida, United States, 33316 | |
University of Miami | |
Miami, Florida, United States, 33101 | |
University of South Florida | |
Tampa, Florida, United States, 33606 | |
United States, Illinois | |
Stroger Hospital of Cook County | |
Chicago, Illinois, United States, 60612 | |
United States, Louisiana | |
Tulane University | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
University of Maryland Medical School | |
Baltimore, Maryland, United States, 21204 | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21224 | |
United States, Massachusetts | |
Childrens Hospital Boston | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
Weill Medical College of Cornell University-New York Presbyterian Hospital | |
New York City, New York, United States, 10021 | |
Mount Sinai Hospital | |
New York City, New York, United States, 10128 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Puerto Rico | |
University Pediatric Hospital | |
San Juan, Puerto Rico, 00936 |
Study Chair: | Bret Rudy, MD | Children's Hospital of Philadelphia |
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00106678 History of Changes |
Other Study ID Numbers: |
ATN 023B |
First Posted: | March 29, 2005 Key Record Dates |
Last Update Posted: | March 1, 2017 |
Last Verified: | February 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
HIV Antiretroviral therapy (ART) HAART Adherence Barriers |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |