Prevalence of HPV and Intraepithelial Neoplasia Biomarkers in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- HPV infection
研究概览
简要总结
This study will assess the prevalence of HPV infection in perinatally HIV-infected adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Have any conditions that may interfer with subjects' ability to understand and consent to the study
结局指标
主要结局
HPV infection
时间窗: 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
次要结局
- E6/E7(48 weeks)
- HPV vaccine(48 weeks)
- intraepithelial neoplasia(48 weeks)