Community Implementation of Urine HPV Test and Reflex DNA Methylation Test in Cervical Cancer Screening

Aims:

The project aims to explore the acceptability and feasibility of a self-sampling, urine-based HPV test (INDICAID HPV Urine Test) in a community setting, and the effectiveness of DNA methylation test for triaging high-risk HPV (HR-HPV) positive women to colposcopy examination compared to the current standard triage methods of cytology and HPV16/18 genotyping.

There are two main hypotheses:

1. Urine self-sampling for HPV testing is an acceptable cervical screening option for women in the community.
2. Combining urine HPV testing with DNA methylation will increase the detection rate of high-grade lesions without increasing the colposcopy referral rate.

Target participants:

Women between the ages of 26-65 and have a history of sexual activity, not have a history of total hysterectomy or cervical cancer, not currently pregnant, not currently under treatment of cervical dysplasia or cervical cancer.

This is a prospective study and women who are willing to undergo urine self-sampling for HPV test will be recruited from various communities, such as Specialist out-patient clinics of Queen Mary Hospital (Hong Kong), public areas in Queen Mary Hospital (such as lobby of out-patient clinics and corridors), District Health Centres, the Family Planning Association (FPA) clinics, Anticancer Society, Christian Action, Non Government Organizations (NGO), private organizations, and online.

A total of 8,620 women are needed to be recruited to the study: approximately 4,700 onsite and 4,000 online.

Study procedures:

Self-collected urine samples from study subjects recruited in various communities will be examined using the INDICAID HPV Urine Test. Women with positive urine HPV results will undergo further testing, including urine DNA methylation and co-testing (cytology and HPV genotyping). They will be triaged to colposcopy when test results show clinical indications. The acceptability and feasibility of the urine test will be assessed by calculating the self-sample uptake rate and analyzing participant-reported questionnaires. The detection rate of high-grade lesions and the colposcopy referral rate will be compared between DNA methylation testing and the current standard methods.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer Screening

• Study Type: Observational
• Enrollment (Estimated): 8620

Contacts and Locations

• Study Contact: Name: Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK); Phone Number: 852-22554265; Email: kklchan@hku.hk
• Study Contact Backup: Name: Tina Na Dr WEI, PhD; Phone Number: 852-22554265; Email: tinawei@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Obstetrics and Gynaecology, the University of Hong Kong
    • Contact: Tina WEI, PhD; Phone Number: 852-22554265; Email: tinawei@hku.hk
    • Contact: Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK); Phone Number: 852-22554265; Email: kklchan@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women who are willing to undergo urine self-sampling for HPV test will be recruited from various communities, such as Specialist out-patient clinics of Queen Mary Hospital (Hong Kong), District Health Centers, the Family Planning Association (FPA) clinics, Anticancer Society, Christian Action, Non Government Organizations (NGO), private organizations and online.

Description

Inclusion Criteria:

• Women aged 26-65
• History of sexual activity

Exclusion Criteria:

• Pregnancy
• History of total hysterectomy
• History of cervical cancer
• Currently under treatment for cervical dysplasia or cervical cancer
• Unwilling to participate in the study
• Cannot give written consent to the procedure

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore the effectiveness of urine self-sample HPV test as screening tool in cervical cancer screening	Comparison of high-grade squamous intraepithelial lesion (HSIL) detection rate and colposcopy referral rate by different triaging methods: cytology, HPV16/18 genotyping or DNA methylation test.	through study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore the feasibility of urine self-sample HPV test in community application	Uptake rate of the urine self-sample HPV test (calculated by the number of samples returned/the number of self-samples bottle distributed).	15 months
To explore the acceptability of urine self-sample HPV test in community application	Acceptability of the urine self-sample HPV test in cervical cancer screening by questionnaires survey	15 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Innovation and Technology Commission, Hong Kong; Phase Scientific International Limited
• Investigators: Principal Investigator: Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK), Department of Obstetrics and Gynaecology, the University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: triage; self-sampling; Cervical cancer screening; methylation; urine HPV test
• Other Study ID Numbers: UW24-382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No