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临床试验/NCT05125380
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

Lund University1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2021年12月1日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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