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
58 participants
OBSERVATIONAL
2015-11-30
2016-03-31
Brief Summary
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Detailed Description
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The specific aims of this study address issues within a larger domain of questions about the primacy of decisional autonomy, and associations of autonomous research consent and subsequent participation-associated outcomes. This mixed-methods study will enroll young men who have sex with men (YMSM) and transgender women who have sex with men who are currently or were previously enrolled in the ATN 110 or ATN 113 study.
Data from the web-based survey will be used to test hypotheses about the relationships between participant age, elements of the consent process, and two key participation outcomes (early adherence to PrEP, HIV seroconversion) in the ATN 110 or ATN 113 study. Data from the qualitative interview will be used to explore in further depth age-related vulnerability and disclosure vulnerabilities manifested for participants and whether/how they influenced ATN 110 and ATN 113 study outcomes. The interview will also assess decisional support and the benefits or harms associated with participation.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Subjects Currently or Previously Enrolled in ATN 110/ATN 113
Younger and older YMSM and transgender women who have sex with men, ages 15 through 22 years, inclusive, at the time of consent into the ATN 110 or ATN 113 study.
No interventions assigned to this group
Sub-Sample of Subjects to Complete Qualitative Interview
A sub-sample of subjects who completed the web-based survey and indicated willingness to complete the qualitative interview.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Is currently or was previously enrolled in the ATN 110 or ATN 113 study; and
* Is willing and able to provide informed consent via online informed consent form (ICF).
Exclusion Criteria
* Prematurely discontinued from the ATN 110 or ATN 113 study due to withdrawal of consent or inadvertent enrollment.
* Inability to complete the web-based quantitative structured self-completed survey in its entirety in a single sitting immediately after consent is provided.
15 Years
22 Years
MALE
Yes
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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Sybil Hosek, Ph.D.
Role: STUDY_CHAIR
John Stroger Hospital of Cook County
J. Dennis Fortenberry, M.D.
Role: STUDY_CHAIR
Indiana University School of Medicine
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
University of Southern Florida College of Medicine
Tampa, Florida, United States
Stroger Hospital of Cook County
Chicago, Illinois, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Fenway Institute
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Related Links
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ATN Website
Other Identifiers
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ATN 137
Identifier Type: -
Identifier Source: org_study_id