Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Uterine Cervical Neoplasms
- Sponsor
- National Healthcare Group Polyclinics
- Enrollment
- 650
- Locations
- 1
- Primary Endpoint
- Detection of high-risk Human Papillomavirus (HPV) DNA
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Ng Xin Rong
Family Physician
National Healthcare Group Polyclinics
Eligibility Criteria
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
Outcomes
Primary Outcomes
Detection of high-risk Human Papillomavirus (HPV) DNA
Time Frame: 3 months
Difference in detection of high-risk HPV DNA between 2 arms
Secondary Outcomes
- Facilitators and barriers of uptake of cervical cancer screening(1 year)
- Detection of cervical intraepithelial neoplasia (CIN) 2, CIN 3 and cervical cancers(2 years)
- Cost-effectiveness of cervical cancer screening(2 years)
- Feasibility of self-sampling cervical cancer screening(1 year)
- Uptake of cervical cancer screening(3 months)
- Colposcopy referrals(2 years)
- Treatments for CIN 2, CIN 3 and cervical cancers(2 years)
- Risk factors for cervical cancer and CIN(2 years)