Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
NCT Number: NCT06528184
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uterine Cervical Neoplasms
Interventions: DIAGNOSTIC_TEST: Self-sampled HPV DNA testing|DIAGNOSTIC_TEST: Clinician-sampled HPV DNA test
Sponsor: National Healthcare Group Polyclinics
Collaborators: National Healthcare Group, Singapore|KK Women's and Children's Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 968
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2026-12

Summary:
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%.

Primary Outcome Measures: Detection of high-risk Human Papillomavirus (HPV) DNA, Difference in detection of high-risk HPV DNA between 2 arms, 1 year
Secondary Outcome Measures: Uptake of cervical cancer screening, Difference in uptake of cervical cancer screening between 2 arms. Based on the number of cervical cancer screening tests that are processed and have available results., 1 year|Colposcopy referrals, Difference in colposcopy referrals between 2 arms. Based on the number of colposcopy referrals made to the tertiary hospital for abnormal cervical cancer screening test results in either arm., 1 year|Detection of cervical intraepithelial neoplasia (CIN) 2, CIN 3 and cervical cancers, Difference in detection of CIN 2, CIN 3 and cervical cancers between both arms., 2 years|Treatments for CIN 2, CIN 3 and cervical cancers, Difference in treated CIN 2, CIN 3 and cervical cancers between both arms. Based on the number of participants with CIN 2, CIN 3 and cervical cancers that have undergone treatments by a gynecologist in either arm., 2 years|Cost-effectiveness of cervical cancer screening, Difference in cost-effectiveness of offering cervical cancer screening between both arms. This includes the cost of screening and follow-up visits in primary care, the cost of further investigations in primary and tertiary care and the cost of treatment for CIN and cervical cancer in tertiary care., 2 years|Facilitators and barriers of uptake of cervical cancer screening, Assessing the factors associated with uptake of cervical cancer screening. These factors include demographics of participants (age, ethnicity, education level, marital status, housing type, employment status), Body Mass Index, obstetrics-related factors (menopausal status, pregnancies, previous cervical cancer screening tests, use of tampons or menstrual cups, previous HPV vaccinations) as well as beliefs and attitudes towards cervical cancer screening. These variables will be collected from questionnaires., 1 year|Feasibility of self-sampling cervical cancer screening, Assessing the preferences for next screening and the experience of the sampling procedure (ease of conducting, comfort, anxiety, embarrassment, unpleasantness and trusting of results) from questionnaires., 1 year|Risk factors for cervical cancer and CIN, Assessing the factors associated with cervical cancer and CIN. These factors include demographics of participants, family history of cervical cancer, smoking status, use of contraceptives, immunosuppressive conditions and sexual history and obstetrics-related factors. These variables will be collected from questionnaires., 2 years