Managerial Database II

Acquired Immunodeficiency Syndrome Clinical Trial

Official title:

Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322217
• Other study ID #: ATN 106
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: February 27, 2017
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	The Fenway Institute-Fenway Health	Boston	Massachusetts
United States	Wayne State University-Children's Hospital of Michigan	Detroit	Michigan
United States	Baylor College of Medicine - Pediatrics Allergy and Immunology	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   ATN Website