NCT06528184

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: National Healthcare Group Polyclinics · Other Government
• Sex: Female
• Age: 30 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

• Uterine Cervical Neoplasms

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-08-05
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-07-30
• Last updated: 2025-02-10

Locations

1 site across 1 country: Singapore