Health TrialsbyHealthPanel

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

ConditionUterine Cervical Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-69
SponsorNational Healthcare Group Polyclinics

About this trial

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%.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

30-69 years old female Singapore citizens

Due for cervical cancer screening

Engaged in sexual intercourse before

Able to give informed consent

Disqualifiers

Virgo intacta

Pregnancy

History of cervical cancer, precancerous cervical lesions and total hysterectomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: Usual care armActive comparator 1 intervention
Group B: Intervention armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Detection of high-risk Human Papillomavirus (HPV) DNA

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

Time frame
3 months

Secondary outcomes

1

Uptake of cervical cancer screening

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.

Time frame
3 months
2

Colposcopy referrals

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.

Time frame
2 years
3

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

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

Time frame
2 years
4

Treatments for CIN 2, CIN 3 and cervical cancers

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Healthcare Group Polyclinics

Lead sponsor

National Healthcare Group, Singapore

Collaborator

KK Women's and Children's Hospital

Collaborator

Source ClinicalTrials.gov
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