Clinical trial NCT06528184: Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
Official title: Evaluating the Impact of Different Methods of HPV DNA Testing for Cervical Cancer Screening in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Cervical Neoplasms
Lead sponsor: National Healthcare Group Polyclinics
Sponsor class: OTHER_GOV
Collaborators: name: National Healthcare Group, Singapore
name: KK Women's and Children's Hospital
First posted: 2024-07-30
Enrollment: 650
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: Detection of high-risk Human Papillomavirus (HPV) DNA
timeFrame: 3 months
Secondary outcomes:
measure: Uptake of cervical cancer screening
timeFrame: 3 months
measure: Colposcopy referrals
timeFrame: 2 years
measure: Detection of cervical intraepithelial neoplasia (CIN) 2, CIN 3 and cervical cancers
timeFrame: 2 years
measure: Treatments for CIN 2, CIN 3 and cervical cancers
timeFrame: 2 years
measure: Cost-effectiveness of cervical cancer screening
timeFrame: 2 years
measure: Facilitators and barriers of uptake of cervical cancer screening
timeFrame: 1 year
measure: Feasibility of self-sampling cervical cancer screening
timeFrame: 1 year
measure: Risk factors for cervical cancer and CIN
timeFrame: 2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Healthcare Group Polyclinics
Study officials:
affiliation: National Healthcare Group Polyclinics
name: Ng Xin Rong, MBBS
role: PRINCIPAL_INVESTIGATOR
References: