跳至主要内容
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2021年12月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Cervical Cancer
发起方
Lund University
入组人数
1200
试验地点
1
主要终点
Sensitivity and specificity of VIA and VIA/VILI as triage test
状态
招募中
最后更新
2年前

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
注册库
clinicaltrials.gov
开始日期
2021年12月1日
结束日期
2024年9月
最后更新
2年前
研究类型
Interventional
研究设计
Single Group
性别
Female

研究者

责任方
Sponsor

入排标准

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)

研究点 (1)

Loading locations...

相似试验