Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
- Conditions
- Uterine Cervical Neoplasms
- Interventions
- Diagnostic Test: Self-sampled HPV DNA testingDiagnostic Test: Clinician-sampled HPV DNA test
- Registration Number
- NCT06528184
- Lead Sponsor
- National Healthcare Group Polyclinics
- Brief 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%.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 650
- 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
- Virgo intacta
- Pregnancy
- History of cervical cancer, precancerous cervical lesions and total hysterectomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm Self-sampled HPV DNA testing Participants will be offered clinician-sampling or self-sampling for HPV DNA testing to determine if they are agreeable to undergo screening using either modality. Usual care arm Clinician-sampled HPV DNA test Participants will only be offered clinician-sampling for HPV DNA testing to determine if they are agreeable to undergo screening. Intervention arm Clinician-sampled HPV DNA test Participants will be offered clinician-sampling or self-sampling for HPV DNA testing to determine if they are agreeable to undergo screening using either modality.
- Primary Outcome Measures
Name Time Method Detection of high-risk Human Papillomavirus (HPV) DNA 3 months Difference in detection of high-risk HPV DNA between 2 arms
- Secondary Outcome Measures
Name Time Method Facilitators and barriers of uptake of cervical cancer screening 1 year 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.
Detection of cervical intraepithelial neoplasia (CIN) 2, CIN 3 and cervical cancers 2 years Difference in detection of CIN 2, CIN 3 and cervical cancers between both arms.
Cost-effectiveness of cervical cancer screening 2 years 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.
Feasibility of self-sampling cervical cancer screening 1 year 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.
Uptake of cervical cancer screening 3 months 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.
Colposcopy referrals 2 years 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.
Treatments for CIN 2, CIN 3 and cervical cancers 2 years 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.
Risk factors for cervical cancer and CIN 2 years 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.
Trial Locations
- Locations (1)
National Healthcare Group Polyclinics
🇸🇬Singapore, Singapore