Cervical pre-cancer and cervical cancer Cancer Malignant neoplasms of cervix uteri
Conditions
Interventions
Point-of-care HPV-DNA testing using self-collected vaginal specimens tested on the Cepheid GeneXpert platform (Xpert HPV Test). Women having a positive HPV test result are offered a pelvic examination
Sponsors
Kirby Institute UNSW Sydney
Eligibility
Sex/Gender
Female
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The performance of the Xpert HPV Test for the detection of underlying high-grade intraepithelial lesions (HSIL) when provided at point-of-care using self-collected vaginal specimens. Performance for the detection of underlying HSIL will be evaluated using the following standard diagnostic evaluation criteria: 1. Sensitivity 2. Specificity 3. Positive predictive value 4. Negative predictive value We will calculate the sensitivity, specificity, positive and negative predictive values (with 95% confidence intervals) of the Xpert HPV Test to detect HSIL. Performance will be evaluated at enrolment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at the baseline, around 3-6 months after enrolment (study mid-point) and 12-18 months after enrolment (end of the trial): 1. Cost-effectiveness of point-of-care Xpert HPV testing for the early detection and treatment of cervical pre-cancer lesions. Standard cost-effectiveness analyses will be performed by identifying the cost-effectiveness frontier and calculating the incremental cost-effectiveness ratios (ICERs) of strategies on the frontier compared to the next most cost-effective strategy. We will calculate all cost-effectiveness ratios as cost per life year saved. 2. Health system implementation requirements of point-of-care Xpert HPV testing for the early detection and treatment of cervical pre-cancer lesions. Health system implementation challenges and benefits will be evaluated in terms of: 2.1. Patient-flow and turnaround-time 2.2. Work-flow and staff time 2.3. Training and supervision needs 2.4. Procedures for finance, payment and health information 2.5. Logistics and management 2.6. Shifts in client-provider relationships when moving from current routine screening (based on VIA alone or Pap test) to HPV-based screening. 3. Acceptability of point-of-care Xpert HPV testing for the early detection and treatment of cervical pre-cancer lesions: 3.1. Acceptability of the intervention from client and health provider perspectives will be analysed using quantitative and qualitative methods 3.2. Key findings from each approach will be triangulated in order to allow robust conclusions to be made regarding acceptability. 3.3. We will calculate the proportion of women who consider the intervention ‘acceptable’ or ‘highly acceptable’ using quantitative data collected in study-specific CRFs 3.4. Qualitative data will be collected from s | — |
Countries
Australia, Papua New Guinea
Outcome results
None listed