Clinical trial NCT01009827: Managerial Database II
Official title: Network-Wide Assessment of Current Health Status and Behavioral Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: Medication adherence
Substance use
Sexual risk behaviors
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2009-11-09
Enrollment: 1712
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: within 2 weeks of enrollment
Secondary outcomes:
measure: 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.
timeFrame: 1.3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Washington
country: United States
facility: Childrens National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Childrens Diagnostic & Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
state: Illinois
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: NY
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Childrens Research Hospital
state: Tennessee
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: Adolescent Trials Network
name: Heather Huszti, Ph.D.
role: STUDY_CHAIR
References: