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

Completed

• Conditions: HIV Infection

• Registration Number: NCT01492842
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-15
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2016-03
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of HPV infection, outcome defined as HPV positive or HPV negative	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

Name	Time	Method
Behavioral Factors	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	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	1 year	HIV viral load (copies/ml), EBV \[(copies of EBV PHC( per human cells)\] and KSHV (HHV-8) \[copies of HHV-8 PHC (per human cells)\]

Trial Locations

Locations (5)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

The Fenway Institute; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States