Managerial Database II
This study has been completed.
Sponsor:
Westat
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Westat
ClinicalTrials.gov Identifier:
NCT01009827
First received: November 6, 2009
Last updated: March 1, 2016
Last verified: March 2016
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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 the ATN sites.
| Condition | Intervention |
|---|---|
|
HIV |
Other: Observation |
| 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 |
Resource links provided by NLM:
Further study details as provided by Westat:
Primary Outcome Measures:
- 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. [ Time Frame: within 2 weeks of enrollment ] [ Designated as safety issue: No ]
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: 1.3 years ] [ Designated as safety issue: No ]
| Enrollment: | 1712 |
| Study Start Date: | October 2009 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Other: 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.
|
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| Ages Eligible for Study: | 12 Years to 24 Years (Child, Adult) |
| 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 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.
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009827
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009827
Locations
| United States, California | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| University of California San Francisco | |
| San Francisco, California, United States, 94117 | |
| United States, District of Columbia | |
| Childrens National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Childrens Diagnostic & Treatment Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33101 | |
| University of South Florida | |
| Tampa, Florida, United States, 33606 | |
| United States, Illinois | |
| Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital | |
| Chicago, Illinois, United States, 60612 | |
| Childrens Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| United States, Louisiana | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Mount Sinai Medical Center | |
| NY, New York, United States, 10128 | |
| United States, Pennsylvania | |
| Childrens Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| St. Jude Childrens Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| Puerto Rico | |
| University of Puerto Rico | |
| San Juan, Puerto Rico, 00936-5067 | |
Sponsors and Collaborators
Westat
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Investigators
| Study Chair: | Heather Huszti, Ph.D. | Adolescent Trials Network |
More Information
Additional Information:
| Responsible Party: | Westat |
| ClinicalTrials.gov Identifier: | NCT01009827 History of Changes |
| Other Study ID Numbers: | ATN 086 |
| Study First Received: | November 6, 2009 |
| Last Updated: | March 1, 2016 |
| Health Authority: | United States: Federal Government |
Keywords provided by Westat:
|
Medication adherence Substance use Sexual risk behaviors |
ClinicalTrials.gov processed this record on September 29, 2016