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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492842
• Other study ID #: ATN 114
• Status: Completed
• Phase: N/A
• First received: October 17, 2011
• Last updated: February 27, 2017
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection
• HIV Infections
• Infection
• Papillomavirus Infections

Locations

Country	Name	City	State
United States	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	Baylor College of Medicine	Houston	Texas

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   ATN website