Studies have shown that offering self-sampling for HPV testing (HPV self-sampling) can improve the cervical cancer screening program. In two studies in the Netherlands (PROHTECT-1 and -2), in which HPV self-sampling was offered to non-attendees of the regular screening programme, about 30% of women responded by submitting a self-sample. Pooled data from these studies show that HPV self-sampling targets a substantial portion of non-attendees of all ethnic groups who have not regularly been screened. The data indicate that HPV self-sampling can reach the women at highest risk of cervical cancer.
In a third study (PROHTECT-3), a molecular triage assay directly applicable to self-samples of HPV-positive women was evaluated against cytology triage on a physician-taken follow-up cervical scrape. Molecular triage (i.e., DNA methylation analysis of cancer-related genes) on HPV-positive self-samples was found non-inferior to cytology triage in the detection of CIN2+. This molecular approach obviates the need for an additional visit to a physician and reduces time to CIN2+ diagnosis, but at the cost of more colposcopy referrals. In another study (PROHTECT-3b), the performance of two self-sampling methods (brush and lavage) was compared among 30,130 women not attending cervical screening. The study showed that offering a brush-based device to non-attendees is non-inferior to offering a lavage-based device in terms of participation. The two self-sampling methods were equally effective in detecting HPV and CIN2+/CIN3+, and performed similarly with respect to user comfort and women acceptance.
In a current study (IMPROVE), a prospective randomized pilot implementation trial of HPV self-sampling in primary screening, a comparison of cervical screening (using HPV testing plus reflex cytology triage testing) via self-sampling and clinician-sampling among regular screening responders is ongoing. Studies have reported that HPV self-sampling can have a similar sensitivity for CIN2+ as HPV testing on a cervical scrape obtained by a physician, although this may depend on the self-sampling device, HPV testing method and protocols used.
When proven clinically non-inferior to HPV testing on physician-collected cervical scrapes, HPV self-sampling may not only be used to complement current screening programs by increasing screening coverage (i.e., targeting non-attendees), but may also be offered as alternative to all women invited for cervical screening.