Managerial Database II
Network-Wide Assessment of Current Health Status and Behavioral Risk Factors
1 other identifier
observational
1,712
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2009
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
November 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFebruary 28, 2017
March 1, 2016
1.3 years
November 6, 2009
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 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.
1.3 years
Study Arms (1)
AMTU Clients
All HIV-infected adolescents and young adults engaged in care at the 15 sites 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.
Interventions
Participants will have biomedical information extracted from their medical chart, will complete the ACASI questionnaire and have a face-to-face post-ACASI debriefing interview administered. Participants who do not have a documented HIV-1 viral load and/or CD4+ T-cells count from within the previous six months will also have venipuncture performed to obtain a blood sample for these tests to be performed.
Eligibility Criteria
All HIV-infected adolescents and young adults engaged in care at the 15 sites 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 included in the master list from which the study sample will be derived.
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;
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Childrens Hospital Los Angeles
Los Angeles, California, 90027, United States
University of California San Francisco
San Francisco, California, 94117, United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010, United States
Childrens Diagnostic & Treatment Center
Fort Lauderdale, Florida, 33316, United States
University of Miami School of Medicine
Miami, Florida, 33101, United States
University of South Florida
Tampa, Florida, 33606, United States
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, 60612, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Mount Sinai Medical Center
New York, New York, 10128, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105-2794, United States
University of Puerto Rico
San Juan, 00936-5067, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Heather Huszti, Ph.D.
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
November 6, 2009
First Posted
November 9, 2009
Study Start
October 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
February 28, 2017
Record last verified: 2016-03