Behavioral, Immunologic and Virologic Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV-Infection
ATN 114 is a cross-sectional substudy of ATN 106. In addition to sharing data collected in
ATN 106, an oral rinse sample along with the subject's self reported history and medical
chart abstraction of HPV vaccination status and medical chart abstraction of a history of
oral condylomata, oral dysplasia and oral tumor viruses will be collected in ATN 114.
Recruitment is expected to last approximately one year, similar to the same timeframe for
ATN 106. Enrollment may be terminated earlier at the discretion of the ATN Executive
Committee and/or the ATN 114 protocol team should ATN 106 also terminate enrollment early.
Individuals who have agreed to participate in ATN 106 may be simultaneously approached at
any clinic visit, or, for community-based sites, contacted directly for participation in ATN
114. Site staff may also contact individuals via phone, e-mail, or any other agreed-upon
methods of communication. Site staff should try as much as possible to incorporate the study
visit into a regularly scheduled clinic visit.
Observational
Observational Model: Cohort, Time Perspective: Cross-Sectional
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
No
Jessica Kahn, MD
Study Chair
Cincinnati Childrens Hospital Medical Center
United States: Federal Government
ATN 114
NCT01492842
September 2011
June 2012
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Johns Hopkins University | Baltimore, Maryland 21205 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
University of Colorado Denver | Denver, Colorado 80262 |
The Fenway Institute | Boston, Massachusetts 02215 |