MedPath

Managerial Database II

Completed
Conditions
HIV
Interventions
Other: Observation
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
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;
  • 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)
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Exclusion Criteria
  • 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.
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
AMTU ClientsObservationAll 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.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 of Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

🇺🇸

Chicago, Illinois, United States

Childrens National Medical Center

🇺🇸

Washington, District of Columbia, United States

Childrens Diagnostic & Treatment Center

🇺🇸

Fort Lauderdale, Florida, United States

Childrens Hospital Los Angeles

🇺🇸

Los Angeles, California, United States

Childrens Memorial Hospital

🇺🇸

Chicago, Illinois, United States

Mount Sinai Medical Center

🇺🇸

NY, New York, United States

University of Maryland

🇺🇸

Baltimore, Maryland, United States

St. Jude Childrens Research Hospital

🇺🇸

Memphis, Tennessee, United States

University of Puerto Rico

🇵🇷

San Juan, Puerto Rico

University of California San Francisco

🇺🇸

San Francisco, California, United States

University of Miami School of Medicine

🇺🇸

Miami, Florida, United States

University of South Florida

🇺🇸

Tampa, Florida, United States

Tulane University Health Sciences Center

🇺🇸

New Orleans, Louisiana, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

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