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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2026-12-31

Brief Summary

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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%.

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Detailed Description

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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

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Uterine Cervical Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual care arm

Participants will only be offered clinician-sampling for HPV DNA testing to determine if they are agreeable to undergo screening.

Group Type ACTIVE_COMPARATOR