Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV
Behavioral, Immunologic and Virologic Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV-Infection
1 other identifier
observational
272
1 country
5
Brief Summary
The proposed study is a substudy of ATN 106 and a cross sectional study intended to be conducted at each of the AMTUs newly participating in ATN III. The intent is to enroll all youth with behaviorally-acquired HIV who have enrolled in ATN 106. The study involves a review of the subjects' medical chart and a collection of an oral rinse sample.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFebruary 28, 2017
March 1, 2016
9 months
October 17, 2011
February 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of HPV infection, outcome defined as HPV positive or HPV negative
Beta-globin positive samples (reported as Positive/negative; there is no unit of measure) will be considered evaluable and classified as HPV-positive if any of the 37 HPV DNA types were detected) and HPV negative if all HPV types were negative.
1 year
Secondary Outcomes (3)
Behavioral Factors
1 year
Immunologic factors
1 year
Virologic factors
1 year
Study Arms (1)
Youth with behaviorally-acquired HIV who enrolled in ATN 106
Behaviorally-acquired HIV-infected adolescents and young adults, ages 12-24, inclusive, who have enrolled in ATN 106.
Eligibility Criteria
Behaviorally-acquired HIV-infected adolescents and young adults, ages 12-24, inclusive, who have enrolled in ATN 106.
You may qualify if:
- Behaviorally acquired HIV-infection as indicated by medical chart abstraction or self-reported history of sexual risk and/or needle using behaviors; and
- Completion of the ATN 106 study visit (the same day or up to a maximum of 14 calendar days).
You may not qualify if:
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's 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 for ATN 114.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Colorado Denver
Aurora, Colorado, 80045, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
The Fenway Institute
Boston, Massachusetts, 02215, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jessica Kahn, MD
Cincinnati Childrens Hospital Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2011
First Posted
December 15, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
February 28, 2017
Record last verified: 2016-03