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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Behavioral, Immunologic and Virologic Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV-Infection

Conditions
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HIV Infection

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Youth with behaviorally-acquired HIV who enrolled in ATN 106<br>Behaviorally-acquired HIV-infected adolescents and young adults, ages 12-24, inclusive, who have enrolled in ATN 106. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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/= | 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) | 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)] | 1 year |