Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
HIV Infection |
| Study Type: | Observational |
| 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 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 [ 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)]
| Enrollment: | 272 |
| Study Start Date: | September 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 12 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Behaviorally-acquired HIV-infected adolescents and young adults, ages 12-24, inclusive, who have enrolled in ATN 106.
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.
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT01492842 History of Changes |
| Other Study ID Numbers: | ATN 114 |
| Study First Received: | October 17, 2011 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Warts Papillomavirus Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases DNA Virus Infections Skin Diseases, Viral Tumor Virus Infections Neoplasms Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013