Managerial Database II
- Conditions
- HIV
- Registration Number
- NCT01009827
- 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 the ATN sites.
- Detailed Description
The proposed study is a cross sectional study intended to be conducted at each of the 15 Adolescent Medicine Trials Units (AMTUs) participating in the ATN 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 Compute-Assisted Self-Interview (ACASI); biomedical information will be collected through medical chart abstraction.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1712
- 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;
- Engaged in care at the AMTU or its affiliate and/or partnering clinic. Individuals will be considered to be engaged in care if:
- Diagnosed less than or equal to 12 months prior to the date of approval to generate the master list and has attended a minimum of one visit since diagnosis for the management of HIV disease or its sequelae; or
- Diagnosed more than 12 months prior to the date of approval to generate the master list and has had a minimum of one visit, as described above, within the past 12 months.
- Ability to understand written and/or verbal English
- Ability and willingness to provide signed consent/assent;
- Parental/legal guardian permission (if applicable)
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individuals' 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rates of adherence to medical regimens, sexual risk behavior, substance use and mental health concerns; basic demographic and biomedical data for adolescents and young adults with HIV infection engaged in care at the AMTUs. within 2 weeks of enrollment
- 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. 1.3 years
Trial Locations
- Locations (15)
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Childrens National Medical Center
🇺🇸Washington, District of Columbia, United States
Childrens Diagnostic & Treatment Center
🇺🇸Fort Lauderdale, Florida, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
🇺🇸Chicago, Illinois, United States
Childrens Memorial Hospital
🇺🇸Chicago, Illinois, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Scroll for more (5 remaining)Childrens Hospital Los Angeles🇺🇸Los Angeles, California, United States