Study Comparing Self-Sampling and Clinician-Sampling HPV DNA Tests for Cervical Cancer Screening in Women Aged 30 to 69

What this Trial Is About

Researchers are evaluating whether adding self-sampling for Human Papillomavirus HPV DNA testing can increase detection rates of high-risk HPV compared to the usual clinician-sampling method in cervical cancer screening. This study focuses on women aged 30 to 69 who are due for cervical cancer screening, aiming to see if offering self-sampling improves screening uptake and detection outcomes. The trial is a pragmatic, randomized controlled study conducted in public primary care settings to provide evidence on clinical outcomes and cost-effectiveness. Participants are randomly assigned to one of two groups. In the standard care group, women are offered only clinician-sampling HPV DNA testing, where a nurse collects a cervical swab during a speculum exam. In the intervention group, women are first offered clinician-sampling if they decline, they can choose to do HPV DNA testing themselves using a self-sampling kit to collect a mid-vaginal swab. This approach tests whether self-sampling increases participation and detection rates. During the study, participants will be monitored for detection of high-risk HPV DNA within three months. Additional follow-up over two years will track colposcopy referrals, detection and treatment of cervical precancerous lesions and cancers, and cost-effectiveness of screening methods. Researchers will also study factors influencing screening uptake and the feasibility of self-sampling. The total study duration includes initial testing and longer-term clinical outcomes to inform future cervical cancer screening programs.

Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings