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

NCT06528184RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

National Healthcare Group Polyclinics

Enrollment

650

Start Date

2024-08-05

Completion Date

2026-12-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Self-sampled HPV DNA testingClinician-sampled HPV DNA test

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

30 Years – 69 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Detection of high-risk Human Papillomavirus (HPV) DNA

Difference in detection of high-risk HPV DNA between 2 arms

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

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.

Time frame: 2 years

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 2 years

Locations

National Healthcare Group Polyclinics, Singapore, Singapore

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