Field trial of a novel point-of-care HPV ‘self-collect, test and treat’ cervical screening strategy for women in low- and middle-income countries: the HPV-STAT study, Papua New Guinea

Not Applicable

Completed

• Conditions: Cervical pre-cancer and cervical cancer; Cancer; Malignant neoplasms of cervix uteri

• Registration Number: ISRCTN13476702
• Lead Sponsor: Kirby Institute UNSW Sydney

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Study Completion: 2021-03-30
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 4285

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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:<br> 1. Sensitivity<br> 2. Specificity<br> 3. Positive predictive value<br> 4. Negative predictive value<br> We will calculate the sensitivity, specificity, positive and negative predictive values (with 95% confidence intervals) of the Xpert HPV Test to detect HSIL.<br> Performance will be evaluated at enrolment.<br>