Randomised controlled trial evaluating the impact of different methods of HPV DNA testing for cervical cancer screening in Singapore's primary care settings: a study protocol.

Background: Cervical cancer remains a significant public health concern in Singapore, with current screening rates at 43%, well below the national target of 70%. In 2019, human papillomavirus (HPV) DNA testing was introduced into the national cervical cancer screening programme, but barriers to participation include embarrassment, privacy concerns and discomfort with clinician-sampled tests. Self-sampled HPV DNA testing offers a promising alternative by providing more privacy and convenience. This study aims to evaluate the impact of including self-sampled HPV DNA testing as an alternative to clinician-sampling on screening uptake, clinical outcomes and cost-effectiveness in primary care.

Methods: This pragmatic, open-label, two-arm randomised controlled trial employs a Zelen design. A total of 650 women aged 30-69 who are due for cervical cancer screening will be recruited from National Healthcare Group Polyclinics in Singapore. Participants will be randomly assigned to either the intervention arm (offering both self-sampling and clinician-sampling) or the usual care arm (clinician-sampling only). The primary outcome is the proportion of participants in each arm detected with high-risk HPV. Secondary outcomes include the proportion of participants in each arm who undergo cervical cancer screening (uptake), are referred for colposcopy and are detected with CIN 2/3 or cervical cancer, as well as cost-effectiveness. Acceptability and feasibility of self-sampling will be evaluated through post-screening questionnaires. Background: Ethical approval was granted by the National Healthcare Group Domain Specific Review Board. Study results will be disseminated through peer-reviewed journals, healthcare conferences and shared with policymakers to guide potential inclusion of self-sampling in Singapore's national cervical cancer screening programme. Findings from this trial will provide crucial evidence for the potential inclusion of self-sampling in Singapore's national cervical cancer screening programme, which could increase screening rates and improve public health outcomes. Background: ClinicalTrials.gov: NCT06528184.