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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
University of North Carolina, Chapel Hill

Collaborator
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier
NCT01492842

First received: October 17, 2011
Last updated: February 27, 2017
Last Verified: March 2016
History of Changes
Purpose

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

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures

  • Prevalence of HPV infection, outcome defined as HPV positive or HPV negative [ Time Frame: 1 year ]
    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 ]
    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 ]
    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 ]
    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)

Arms
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

    li> 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

Eligibility

Ages Eligible for Study: 12 Years to 24 Years  
Sexes Eligible for Study: All  
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

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

University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

Investigators

Study Chair: Jessica Kahn, MD Cincinnati Childrens Hospital Medical Center
More Information

More Information

Additional Information:

ATN website

Responsible Party: University of North Carolina, Chapel Hill  
ClinicalTrials.gov Identifier: NCT01492842   History of Changes  
Other Study ID Numbers: ATN 114  
Study First Received: October 17, 2011  
Last Updated: February 27, 2017  

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Papillomavirus Infections

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.