Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV
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.
|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|
- 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.
- Behavioral Factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• 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)]
|Study Start Date:||September 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492842
|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|
|Study Chair:||Jessica Kahn, MD||Cincinnati Childrens Hospital Medical Center|