Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2008-05-31
2009-01-31
Brief Summary
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Treatment Readiness Measure (HTRM) to assist clinicians in:
(1) determining whether or not youth living with HIV are ready to initiate HAART and (2) identifying youth who may be in need of additional support services to facilitate their adherence to HAART. The current study will examine the psychometric properties of the HTRM and establish its test-retest reliability over a two week period. If the HTRM is found to be reliable, a subsequent study will examine its predictive validity.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study Group
Participants will complete two audio computer assisted self interviews on laptop computers. This study will also involve the abstraction of participants' viral load and CD4 counts from their medical charts.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Either HAART naïve (defined as never having taken HAART) or HAART experienced (defined as having had at least one experience taking HAART and not having taken HAART for 30 days prior to study entry)
* Not currently on HAART, but planning to initiate HAART within the next 2 months based on provider recommendation
* Enrolled in care at an AMTU or a collaborating site
* Able to speak and understand English
* Willing to provide informed consent, or assent with parental permission (if required by the site IRB) for participation in this study.
Exclusion Criteria
* Determined by the PI (or designee) to be under the influence of psychoactive agents or intoxicated at the time of assessment to a degree that would interfere with successful completion of the questionnaire
* Visibly distraught or unstable
* Any clinical condition that would likely interfere with the participant's ability to complete the study
Participants who are unable to speak English will be excluded from the initial testing of the HTRM's reliability and validity in keeping with traditional tool development strategies. If the initial study indicates that the English version of the HTRM is reliable and valid, appropriate methods will be employed to translate the instrument into Spanish and the reliability and validity will be re-examined for the Spanish version.
13 Years
24 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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M. Isabel Fernández, Ph.D.
Role: STUDY_CHAIR
Adolescent Trials Network
Locations
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Childrens Hospital of 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, Inc
Fort Lauderdale, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
USF College of Medicine
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 Express Mailing Address:
Baltimore, Maryland, United States
Mount Sinai Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St Jude Childrens Research Hospital
Memphis, Tennessee, United States
University of Puerto Rico, Medical Sciences Campus
San Juan, , Puerto Rico
Countries
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Related Links
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Adolescent Trials Network website
Other Identifiers
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ATN 065
Identifier Type: -
Identifier Source: org_study_id
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