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Behavioral, Immunologic and Virologic Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV-Infection


N/A
12 Years
24 Years
Not Enrolling
Both
HIV Infection

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Trial Information

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.

Inclusion Criteria


Inclusion Criteria

- 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).

Exclusion Criteria

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

Prevalence of HPV infection, outcome defined as HPV positive or HPV negative

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Jessica Kahn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cincinnati Childrens Hospital Medical Center

Authority:

United States: Federal Government

Study ID:

ATN 114

NCT ID:

NCT01492842

Start Date:

September 2011

Completion Date:

June 2012

Related Keywords:

  • HIV Infection
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Warts
  • Papillomavirus Infections

Name

Location

Baylor College of MedicineHouston, Texas  77030
Johns Hopkins UniversityBaltimore, Maryland  21205
Children's Hospital of MichiganDetroit, Michigan  48201
University of Colorado DenverDenver, Colorado  80262
The Fenway InstituteBoston, Massachusetts  02215