Managerial Database II

NCT ID: NCT01009827

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1712 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-02-28

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.

Conditions

HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Observation

Intervention Type: OTHER

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.

Interventions

Observation

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.

Intervention Type: OTHER

Eligibility 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;
• 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)

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Huszti, Ph.D.

Role: STUDY_CHAIR

Adolescent Trials Network

Locations

Childrens Hospital Los Angeles

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Childrens Diagnostic & Treatment Center

Fort Lauderdale, Florida, United States

University of Miami School of Medicine

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, United States

Childrens Memorial Hospital

Chicago, Illinois, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

Mount Sinai Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Jude Childrens Research Hospital

Memphis, Tennessee, United States

University of Puerto Rico

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Related Links

http://www.atnonline.org

ATN Website

Other Identifiers

ATN 086

Identifier Type: -

Identifier Source: org_study_id