HPV in Adolescents

Study Overview
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Brief Summary
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This study will assess the prevalence of HPV infection in perinatally HIV-infected adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.

Detailed Description
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Human Papillomavirus (HPV) is the most common sexually transmitted disease and it causes cervical and anal cancer. Prevalence and incidence of HPV infection among young adults who are sexually experienced is high. No data exist for HIV-positive adolescents in regards to HPV infection, cervical and anal intraepithelial neoplasia. This study will compare the prevalence of HPV infection, intraepithelial neoplasia and E6/E7 biomarker at cervical and anal sites among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIV-negative adolescents.

Official Title
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Prevalence of HPV and Intraepithelial Neoplasia Biomarkers in Adolescents

Conditions
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HPV Infection, Cervical/Anal Dysplasia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Perinatally-infected (documented positive HIV enzyme immunoassay (EIA) or nucleic acid testing (NAT) at any time and history of maternal HIV infection) behaviorally-infected (documented positive HIV enzyme immunoassay (EIA) or nucleic acid testing (NAT) at any time after sexual debut without history of maternal HIV infection) female with vaginal or receptive anal intercourse with a male OR male with receptive rectal intercourse with another male Signed informed consent. Volunteers aged 12-17 years can decide whether they wish for their parents to consent for their participation. Due to the confidential nature of the issues being studied, parental consent may be exempted Exclusion Criteria: Have any conditions that may interfer with subjects' ability to understand and consent to the study

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perinatally HIV-infected adolescents<br>Perinatally HIV-infected adolescents | |
| behaviorally HIV-infected adolescents<br>behaviorally HIV-infected adolescents | |
| HIV negative adolescents<br>HIV negative adolescents | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV infection | Prevalence of cervical and anal HPV infection and of oncogenic subtypes, among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIv-negative adolescents | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraepithelial neoplasia | Prevalence of intraepithelial neoplasia among the three study groups and in male and female subjects | 48 weeks | 
| E6/E7 | Prevalence of detected E6/E7 biomarker among the tree study groups and in male and female subjects. Correlation between detected E6/E7 and presence of HPV infection and/or intraepithelial neoplasia Association between HAART use, CD4 counts, plasma HIV RNA level and HIV clinical staging with HPV infection, intraepithelial neoplasia and E6/E7 detection | 48 weeks | 
| HPV vaccine | Proportion of adolescents who would benefit from the current preventive vaccine (i.e. those who have not been infected with oncogenic HPV subtypes 16 and 18) | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, HIV, cervical/anal dysplasia, intraepithelial neoplasia, E6/E7 biomarker, perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, anal and pap smear