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NCT Number: NCT06528184

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

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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Key information

Conditions

Uterine Cervical Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms

Age range

30 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Healthcare Group Polyclinics

Singapore, 138543

Location status: Recruiting

Location contact

Ng Xin Rong, MBBS

CONTACT

[email protected]

65-90929973

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-sampled HPV DNA testing

Diagnostic Test

Participants will be offered HPV DNA testing done through self-sampling (using self-sampling HPV DNA kits to obtain a mid-vaginal swab)

Clinician-sampled HPV DNA test

Diagnostic Test

Participants will be offered HPV DNA testing through clinician sampling (clinician-sampling (speculum examination by a nurse to obtain a cervical swab)

Primary outcomes

  1. Detection of high-risk Human Papillomavirus (HPV) DNA

    Time frame: 3 months

    Difference in detection of high-risk HPV DNA between 2 arms

Secondary outcomes

  1. Uptake of cervical cancer screening

    Time frame: 3 months

    Difference in uptake of cervical cancer screening between 2 arms. Based on the number of cervical cancer screening tests that are processed and have available results.

  2. Colposcopy referrals

    Time frame: 2 years

    Difference in colposcopy referrals between 2 arms. Based on the number of colposcopy referrals made to the tertiary hospital for abnormal cervical cancer screening test results in either arm.

  3. Detection of cervical intraepithelial neoplasia (CIN) 2, CIN 3 and cervical cancers

    Time frame: 2 years

    Difference in detection of CIN 2, CIN 3 and cervical cancers between both arms.

  4. Treatments for CIN 2, CIN 3 and cervical cancers

    Time frame: 2 years

    Difference in treated CIN 2, CIN 3 and cervical cancers between both arms. Based on the number of participants with CIN 2, CIN 3 and cervical cancers that have undergone treatments by a gynecologist in either arm.

  5. Cost-effectiveness of cervical cancer screening

    Time frame: 2 years

    Difference in cost-effectiveness of offering cervical cancer screening between both arms. This includes the cost of screening and follow-up visits in primary care, the cost of further investigations in primary and tertiary care and the cost of treatment for CIN and cervical cancer in tertiary care.

  6. Facilitators and barriers of uptake of cervical cancer screening

    Time frame: 1 year

    Assessing the factors associated with uptake of cervical cancer screening. These factors include demographics of participants (age, ethnicity, education level, marital status, housing type, employment status), Body Mass Index, obstetrics-related factors (menopausal status, pregnancies, previous cervical cancer screening tests, use of tampons or menstrual cups, previous HPV vaccinations) as well as beliefs and attitudes towards cervical cancer screening. These variables will be collected from questionnaires.

  7. Feasibility of self-sampling cervical cancer screening

    Time frame: 1 year

    Assessing the preferences for next screening and the experience of the sampling procedure (ease of conducting, comfort, anxiety, embarrassment, unpleasantness and trusting of results) from questionnaires.

  8. Risk factors for cervical cancer and CIN

    Time frame: 2 years

    Assessing the factors associated with cervical cancer and CIN. These factors include demographics of participants, family history of cervical cancer, smoking status, use of contraceptives, immunosuppressive conditions and sexual history and obstetrics-related factors. These variables will be collected from questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Ng Xin Rong, MBBS

CONTACT

[email protected]

+65 63553000

Sponsors and collaborators

Lead sponsor

National Healthcare Group Polyclinics

Other Gov

Collaborators

  • KK Women's and Children's Hospital
  • National Healthcare Group, Singapore

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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