NCT05125380招募中不适用
Evaluation of an Human Papillomavirus (HPV) Based Screening Algorithm for Low and Middle Income Countries, by Self-sampling in Ethiopia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of VIA and VIA/VILI as triage test
研究概览
简要总结
The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC).
Specific aims are the following:
- To evaluate the algorithm using Visual Inspection with Acetic acid (VIA) and VIA together with Lugol's Iodine (VILI) as triage and to use HPV self-sample to follow up those treated and those with persisting HPV.
- To evaluate the prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae and other STIs in the cohort.
- To determine immune response profiles in high-risk HPV-positive women who cleared, persisted, or developed Cervical Intraepithelial Neoplasia 2/3 (CIN).
- To assess how specific cervicovaginal microbiota compositions are associated with HPV infection, cervical dysplasia, and cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Can give consent, Age above 18
排除标准
- •Women who have undergone hysterectomy
结局指标
主要结局
Sensitivity and specificity of VIA and VIA/VILI as triage test
时间窗: 12 weeks
All HPV pos women will have a cervical biopsy taken
次要结局
- Vaginal Microbiota composition(24 months)
- Prevalence of STI other than HPV(8 weeks)
研究者
研究点 (1)
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