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.
Study Type
OBSERVATIONAL
Enrollment
272
University of Colorado Denver
Aurora, Colorado, United States
Johns Hopkins University
Baltimore, Maryland, United States
The Fenway Institute
Boston, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Prevalence of HPV infection, outcome defined as HPV positive or HPV negative
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.
Time frame: 1 year
Behavioral Factors
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/=
Time frame: 1 year
Immunologic factors
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)
Time frame: 1 year
Virologic factors
HIV viral load (copies/ml), EBV \[(copies of EBV PHC( per human cells)\] and KSHV (HHV-8) \[copies of HHV-8 PHC (per human cells)\]
Time frame: 1 year
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Baylor College of Medicine
Houston, Texas, United States