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Trial Title:
Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
NCT ID:
NCT06528184
Condition:
Uterine Cervical Neoplasms
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Self-sampled HPV DNA testing
Description:
Participants will be offered HPV DNA testing done through self-sampling (using
self-sampling HPV DNA kits to obtain a mid-vaginal swab)
Arm group label:
Intervention arm
Intervention type:
Diagnostic Test
Intervention name:
Clinician-sampled HPV DNA test
Description:
Participants will be offered HPV DNA testing through clinician sampling
(clinician-sampling (speculum examination by a nurse to obtain a cervical swab)
Arm group label:
Intervention arm
Arm group label:
Usual care arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
Females
Minimum age:
30 Years
Maximum age:
69 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
August 2024
Completion date:
December 2026
Lead sponsor:
Agency:
National Healthcare Group Polyclinics
Agency class:
Other
Collaborator:
Agency:
National Healthcare Group, Singapore
Agency class:
Other
Collaborator:
Agency:
KK Women's and Children's Hospital
Agency class:
Other
Source:
National Healthcare Group Polyclinics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06528184
