Managerial Database II
Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III
1 other identifier
observational
513
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2011
CompletedFirst Posted
Study publicly available on registry
March 24, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFebruary 28, 2017
March 1, 2016
1.2 years
March 22, 2011
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Collect information on for adolescents and young adults with HIV infection engaged in care at the AMTUs
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.
1 year
Secondary Outcomes (1)
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
Study Arms (1)
AMTU Clients
All HIV-infected adolescents and young adults engaged in care at sites newly participating in ATN III and their affiliates who are between 12 and 24 years of age, inclusive, are aware of their HIV status and understand written and/or verbal English will be eligible for inclusion in the study. In addition, new patients who have their initial clinic visit within the enrollment period will also be eligible for participation.
Eligibility Criteria
All HIV-infected adolescents and young adults engaged in care at sites newly participating in ATN III and their affiliates who are between 12 and 24 years of age, inclusive, are aware of their HIV status and understand written and/or verbal English will be eligible for inclusion in the study. In addition, new patients who have their initial clinic visit within the enrollment period will also be eligible for participation
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Colorado Denver
Aurora, Colorado, 80045, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
The Fenway Institute-Fenway Health
Boston, Massachusetts, 02115, United States
Wayne State University-Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Baylor College of Medicine - Pediatrics Allergy and Immunology
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Heather Huszti, PhD
Adolescent Trials Network
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2011
First Posted
March 24, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
February 28, 2017
Record last verified: 2016-03