Prospective cohort study to evaluate point-of-care HPV-DNA testing for the early detection and treatment of cervical pre-cancer in high-burden, low-resource settings

Kirby Institute UNSW Sydney0 个研究点目标入组 4,285 人开始时间: 2018年9月25日最近更新: 2022年8月15日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35878625/ (added 26/07/2022)

•1. Aged 30-59 years
•2. Attending a participating Well Woman Clinic
•3. Willing to provide self-collected vaginal swabs for baseline Xpert HPV testing
•4. Willing to comply with study follow-up procedures
•5. Willing to undergo a clinical interview and pelvic examination
•6. Willing to provide self-collected and clinician-collected specimens for laboratory investigations
•7. Able to complete study informed consent procedures, to understand why the study is being carried out, and the potential risks and benefits associated with study participation;
•8. Able to provide reliable contact details to facilitate future community tracing and follow-up

•1. Currently pregnant or given birth in the last 6 weeks
•2. Previous diagnosis of cervical cancer and/or has had a hysterectomy
•3. Permanent disability, that prevents or impedes study participation and/or comprehension (such that it is not possible to obtain informed consent to participate)
•4. Women having their menstrual period at the time of the clinic visit will be advised to return for screening in 1-2 weeks

发起方

Kirby Institute UNSW Sydney