Managerial Database II

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01322217
First received: March 22, 2011
Last updated: October 8, 2013
Last verified: August 2013
  Purpose

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.


Condition
Acquired Immunodeficiency Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Collect information on for adolescents and young adults with HIV infection engaged in care at the AMTUs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 513
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322217

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
The Fenway Institute-Fenway Health
Boston, Massachusetts, United States, 02115
United States, Michigan
Wayne State University-Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Texas
Baylor College of Medicine - Pediatrics Allergy and Immunology
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Study Chair: Heather Huszti, PhD Adolescent Trials Network
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01322217     History of Changes
Other Study ID Numbers: ATN 106
Study First Received: March 22, 2011
Last Updated: October 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Medication adherence
Substance use
Sexual risk behaviors

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2014