Screening for Human Papillomavirus and Cervical Cancer in Young Women With Perinatally Acquired HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Prevalence of Abnormal Cervical Cytology
研究概览
简要总结
This is a cross-sectional, observational study of high-risk HPV status, cervical cytology and HPV vaccine uptake and response in young women with perinatally acquired HIV.
详细描述
This is an observational study of cervical cytology assessment, high risk human papilloma virus (hr-HPV) status, and HPV antibody titres amongst adult women living with perinatally acquired HIV infection (PaHIV). Eligible consenting participants will have two samples taken; firstly, a cervical sample tested for cytology and Hr-HPV with the Cepheid GeneXpert HPV; secondly serum will be assessed for hr-HPV serology. All women with PaHIV, vaccinated and unvaccinated for HPV, over the age of 18 years will be eligible and will be recruited into one of two cohorts: (1) sexually active women: full study, cervical and blood sampling or (2) non-sexually active women, blood sampling only (total n=80). Follow up for abnormal smear results or hr-HPV positivity will be arranged through colposcopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Prevalence of Abnormal Cervical Cytology
时间窗: 1 year
Cervical sample taken in the clinic setting and sent to the laboratory for cytological examination. Prevalence of abnormal cytology is reported as the number of samples that had a non-normal cytology result (e.g. dyskaryotic cells) out of the total number tested
次要结局
- Prevalence of High Risk HPV by Subtype(1 year)
- Prevalence of CIN2+(1 year)
- HPV Serology (16/18)(1 year)