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
  Purpose

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.


Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Behavioral, Immunologic and Virologic Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV-Infection

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)]


Enrollment: 272
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492842

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
The Fenway Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Study Chair: Jessica Kahn, MD Cincinnati Childrens Hospital Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01492842     History of Changes
Other Study ID Numbers: ATN 114
Study First Received: October 17, 2011
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Papillomavirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
DNA Virus Infections
Tumor Virus Infections

ClinicalTrials.gov processed this record on August 01, 2014