HPV in Adolescents

Completed

• Conditions: HPV Infection; Cervical/Anal Dysplasia

• Registration Number: NCT01788852
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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Exclusion Criteria

• Have any conditions that may interfer with subjects' ability to understand and consent to the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV infection	48 weeks	Prevalence of cervical and anal HPV infection and of oncogenic subtypes, among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIv-negative adolescents

Secondary Outcome Measures

Name	Time	Method
E6/E7	48 weeks	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
HPV vaccine	48 weeks	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)
intraepithelial neoplasia	48 weeks	Prevalence of intraepithelial neoplasia among the three study groups and in male and female subjects

Trial Locations

Locations (3)

HIV-NAT; 🇹🇭 Bangkok, Thailand

Department of Pediatrics, Chulalongkorn University; 🇹🇭 Bangkok, Thailand

Thai Red Cross - Anonymous Clinc; 🇹🇭 Bangkok, Thailand