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

National Healthcare Group Polyclinics

Status: Enrolling

Conditions: Uterine Cervical Neoplasms

Treatments: Diagnostic Test: Self-sampled HPV DNA testing; Diagnostic Test: Clinician-sampled HPV DNA test

Study type: Interventional

Funder types: Other

Identifiers

NCT06528184

SCS-GRA-2023-00253 (Other Grant/Funding Number)

2024/00194

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 650 estimated patients

Sex: Female

Ages: 30 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

Usual care arm

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Clinician-sampled HPV DNA test

Intervention arm

Experimental group

Description:

Participants will be offered clinician-sampling or self-sampling for HPV DNA testing to determine if they are agreeable to undergo screening using either modality.

Treatment:

Diagnostic Test: Clinician-sampled HPV DNA test

Diagnostic Test: Self-sampled HPV DNA testing