Overview
Primary objective of the study is to determine the extent that offering of self-sampling in addition to clinician-sampling Human Papillomavirus (HPV) DNA testing will increase detection of HPV DNA through an increase in uptake rates of cervical cancer screening as compared to offering clinician-sampling HPV DNA testing alone.
The hypothesis is that offering additional self-sampling will increase the detection of high-risk HPV DNA by at least 7.7%.
Description
This study is a pragmatic, multi-center, 1:1 randomized controlled trial designed to evaluate the impact of self-sampling HPV DNA testing on clinical outcomes and cost-effectiveness in cervical cancer screening. The trial will compare 2 approaches to HPV DNA testing within public primary care settings.
Participants in the intervention arm will first be offered a clinician-sampling HPV DNA test. If they decline, they will be offered the option of self-sampling HPV DNA test. The control arm will follow the standard protocol of offering only the conventional clinician-sampling HPV DNA test, reflecting the current standard of care in cervical cancer screening.
This study seeks to provide robust evidence on whether self-sampling can improve clinical outcomes, be cost-effective and be feasibility implemented in routine public primary healthcare settings. The findings are expected to inform future guidelines and policies for cervical cancer screening programs.
Eligibility
Inclusion Criteria:
- 30-69 years old female Singapore citizens
- Due for cervical cancer screening
- Engaged in sexual intercourse before
- Able to give informed consent
- Able to read and communicate in English, Chinese or Malay
Exclusion Criteria:
- Virgo intacta
- Pregnancy
- History of cervical cancer, precancerous cervical lesions and total hysterectomy