Uterine Cervical Neoplasms
Conditions
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.
Interventions
DIAGNOSTIC_TESTSelf-sampled HPV DNA testing
Participants will be offered HPV DNA testing done through self-sampling (using self-sampling HPV DNA kits to obtain a mid-vaginal swab)
DIAGNOSTIC_TESTClinician-sampled HPV DNA test
Participants will be offered HPV DNA testing through clinician sampling (clinician-sampling (speculum examination by a nurse to obtain a cervical swab)
Sponsors
National Healthcare Group, Singapore
KK Women's and Children's Hospital
National Healthcare Group Polyclinics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of high-risk Human Papillomavirus (HPV) DNA | 3 months | Difference in detection of high-risk HPV DNA between 2 arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Singapore
Contacts
Primary ContactNg Xin Rong, MBBS
Outcome results
None listed