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Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01492842
First received: October 17, 2011
Last updated: May 8, 2014
Last verified: May 2014

October 17, 2011
May 8, 2014
September 2011
June 2012   (final data collection date for primary outcome measure)
Prevalence of HPV infection, outcome defined as HPV positive or HPV negative [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01492842 on ClinicalTrials.gov Archive Site
  • Behavioral Factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Sexual behaviors:

    • Sexual encounters for male/female: type of sexual contact/in the last 3 months N number of partners by type of sexual contact/in last 3 months

    Substance use behaviors:

    • Tobacco product use (ever used, frequency of use past 3 months); <= 1/month >=1/=week
    • Alcohol use (ever used, frequency of use past 3 months); Irregular/regular
    • Marijuana use (ever used, frequency of use past 3 months); <= 1/month >=1/=week
    • Cocaine use ((ever used, frequency of use past 3 months); <= 1/month >=1/=
  • Immunologic factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The immunological factors will include CD4+ cell count (cell/uL) and severity of disease according to the CDC Staging/Immunologic Category for HIV Disease (No unit of measurements)
  • Virologic factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    HIV viral load (copies/ml), EBV [(copies of EBV PHC( per human cells)] and KSHV (HHV-8) [copies of HHV-8 PHC (per human cells)]
Same as current
Not Provided
Not Provided
 
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

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.

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
Not Provided
Not Provided
Non-Probability Sample

Behaviorally-acquired HIV-infected adolescents and young adults, ages 12-24, inclusive, who have enrolled in ATN 106.

HIV Infection
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
272
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
12 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01492842
ATN 114
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Jessica Kahn, MD Cincinnati Childrens Hospital Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP