ISRCTN13476702
Completed
未知
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 sites4,285 target enrollmentSeptember 25, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cervical pre-cancer and cervical cancer
- Sponsor
- Kirby Institute UNSW Sydney
- Enrollment
- 4285
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35878625/ (added 26/07/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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