Management of HPV test results

There is uncertainty about participation in the Renewed NCSP over the 5-yearly interval and compliance with the follow-up recommendations for HPV-positive women. There is also uncertainty about the timing of impact of HPV vaccination on the numbers of women referred to colposcopy, and about the transitional aspects of the program and impact on colposcopy volumes. These issues will be informed by modelled analysis (see Modelling reports, safety monitoring of the Renewed NCSP, and by emerging data from the Compass trials.

Women who test positive for HPV 16/18 on a self-collected sample will need further investigation. It is unclear at present whether these women would prefer to visit their usual primary care health professional to have a cervical sample for liquid-based cytology taken by someone they know and trust, or be referred directly to specialist colposcopist and have the sample taken at that time. A stepwise protocol involving primary care would involve an extra examination, but might be perceived as less threatening. Several options might be offered, one of which should be further assessment by a female primary care practitioner or specialist.

A large RCT (Compass) is underway comparing 5-yearly HPV testing with 2.5 yearly liquid-based cytology screening in women aged 25–69 years in Victoria.[1] The primary objectives of Compass are:[1]

• to confirm that 5.5-year CIN3+-free survival is non-inferior for HPV screening compared with cytology screening in vaccinated and unvaccinated cohorts
• (if HPV screening is not inferior to cytology screening) to determine if 5.5-year CIN3+ free survival is superior among HPV-screened women who were HPV-negative at baseline, compared with cytology-screened women who were cytology-negative at baseline and at 2.5-year follow-up.
• Compass is providing information on colposcopy referral rates and outcomes and is acting as a sentinel experience for the Renewed NCSP.

Initial results have been published from the pilot component of the Compass trial, relating to outcomes at baseline and 12-month follow-up. Results from 5-year follow-up in the pilot and outcomes at baseline and 12-month follow-up in the main trial are forthcoming.

A body of implementation research on universal self-collection is underway in Victoria.

• EASI-C: (Expanding Access to Self-collection to Increase Cervical Screening participation) aims to support and monitor the implementation of universal access to self-collection by working with general practices in Victoria to identify and mitigate the implementation challenges experienced.
• Do it for Yourself is a demonstration project of universal access to self-collection in Victorian Aboriginal Community Controlled Health Services that aims to explore the impact and acceptability of self-collection for Aboriginal women. The project also aims to evaluate rates of follow up for women testing HPV positive and to document implementation challenges experienced at the service level.

The use of dual-stained cytology for the overexpression of the molecular markers p16 and Ki 67 has been proposed as a strategy for further stratification of risk among HPV-positive women.[1][2][3] In particular, there is a need to determine whether or not dual staining (p16 and Ki67) for women who test positive to HPV (not 16/18) on partial genotyping would materially improve the prediction of cervical cancer risk. The Compass trial is also assessing the role of this technology and initial results are expected in around 2022.