The HPV Self-test as a Test of Cure in the Follow-up of HPV-positive Women in Madagascar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Cervical intra-epithelial neoplasia grade 2 or worse
研究概览
简要总结
The purpose of this study is to find out whether Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.
详细描述
The efficacy and the availability of cold coagulation render it a valuable technique for the treatment of precancerous lesions in low-resource settings. The Human Papillomavirus (HPV) test performed by women themselves (HPV self-test) could be an efficient method to assess the long-term risk of recurrent/persistent disease in women with a history of HPV infection and cervical intra-epithelial lesions grade 2 or higher (CIN2+).
A total of 443 HPV-positive women, aged 30-65 years, have been selected through a screening campaign conducted in Ambanja, Madagascar, between 2013 and 2015. Of these, 260 have been treated by cold coagulation, conisation or electrocauterization. A follow-up visit at 1-3 years after primary screening will be organized for all HPV-positive women detected at primary screening. Participants will perform an HPV self-test. A sample for cytology and HPV testing will also be collected by the physician. The goal of the study will be the histological search for CIN2+ lesions at one to three years after primary screening.
The investigators expect to see that Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women previously positive at HPV testing
排除标准
- •pregnancy
结局指标
主要结局
Cervical intra-epithelial neoplasia grade 2 or worse
时间窗: 4 months
次要结局
未报告次要终点
研究者
Prof. Patrick Petignat
Prof.
University Hospital, Geneva
