Cervical/Anal Dysplasia, HPV Infection
Conditions
Keywords
HPV, HIV, cervical/anal dysplasia, intraepithelial neoplasia, E6/E7 biomarker, perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, anal and pap smear
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.
Interventions
None listed
Sponsors
Thai Red Cross AIDS Research Centre
Chulalongkorn University
SEARCH Research Foundation
We Understand Group
TREAT Asia
The HIV Netherlands Australia Thailand Research Collaboration
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| intraepithelial neoplasia | 48 weeks | Prevalence of intraepithelial neoplasia among the three study groups and in male and female subjects |
| 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) |
Countries
Thailand
Outcome results
None listed