Managerial Database II

Completed

• Conditions: Acquired Immunodeficiency Syndrome

• Registration Number: NCT01322217
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

This study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of HIV positive adolescents receiving care at sites newly participating in ATN III.

Detailed Description

The proposed study is a cross sectional study intended to be conducted at each of the Adolescent Medicine Trials Units (AMTUs) newly participating in ATN III and to enroll all participating patients followed at each site. This approach will allow for the examination of the broad spectrum of youth participating in the ATN, including those newly entered into care.

Psychosocial and risk-taking behavioral data will be collected using Audio Computer-Assisted Self-Interview (ACASI) for English-speaking participants, or a paper-and-pencil Spanish-language survey with identical measures to the ACASI for Spanish-speaking participants; biomedical information will be collected through medical chart abstraction.

Study Timeline

• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Study Start: 2011-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2016-03
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 513

Inclusion Criteria

• Laboratory evidence of HIV-1 infection documented by a positive result on any of the following licensed tests at any time: Any HIV-1 antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA PCR > 1,000 copies/ml;
• Knowledge of HIV positive diagnoses;
• Age 12 years through 24 years, inclusive, at the time of consent;
• Engaged in care at the AMTU or its affiliate and/or partnering clinic. Individuals will be considered to be engaged in care if they have an AMTU (or its affiliate) clinic visit during the enrollment period;
• Ability to understand written and/or verbal English or Spanish.

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Exclusion Criteria

• Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to complete the study measures;
• Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior); or
• Intoxicated or under the influence of alcohol or other substances at the time of consent/assent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect information on for adolescents and young adults with HIV infection engaged in care at the AMTUs	1 year	Collect information on rates of adherence to medical regimens, sexual risk behavior, substance use and mental health concerns, along with basic demographic and biomedical data for adolescents and young adults with HIV infection engaged in care at the AMTUs to better understand the extent of risk behaviors as well as to understand risk and protective factors in this population.

Secondary Outcome Measures

Name	Time	Method
To better understand the complex relationships between adherence to medical regimens, sexual risk behavior, substance use and mental health concerns, and basic demographic and biomedical data in adolescents and young adults with HIV infection.	1 year

Trial Locations

Locations (5)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Baylor College of Medicine - Pediatrics Allergy and Immunology; 🇺🇸 Houston, Texas, United States

The Fenway Institute-Fenway Health; 🇺🇸 Boston, Massachusetts, United States

Wayne State University-Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States