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

NCT06528184 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2025-02-10

No results posted yet for this study

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%.

Conditions

  • Uterine Cervical Neoplasms

Interventions

DIAGNOSTIC_TEST

Self-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_TEST

Clinician-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 & Collaborators

  • National Healthcare Group, Singapore

    collaborator OTHER_GOV
  • KK Women's and Children's Hospital

    collaborator OTHER_GOV
  • National Healthcare Group Polyclinics

    lead OTHER_GOV

Principal Investigators

  • Ng Xin Rong, MBBS · National Healthcare Group Polyclinics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06528184 on ClinicalTrials.gov