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Screening Strategies for Cervical Cancer in Community Clinics

BDCTR ID
BDCTR-2026-000104
Sponsor
Bangladesh Medical University
Information provided by
Dr Rehana Begum (Responsible Party)
Last Update Posted
2026-08-22

Recruiting

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Study Record Versions

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12026-08-22Current
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Viewing V1 (2026-08-22)

Study Details

Study Identification

Unique Protocol IDBMU-ONC-2026-003
Brief TitleScreening Strategies for Cervical Cancer in Community Clinics (HPV-SELF)
Official TitleHPV Self-sampling Versus Clinic-based Visual Inspection to Improve Cervical Cancer Screening Uptake
Secondary IDs

Study Status

Record Verification2026-08
Overall StatusRecruiting
Study Start2026-07-20
Primary Completion2027-04-30
Study Completion2027-07-31
First Submitted
First Submitted that Met QC Criteria2026-07-18
First Posted2026-07-18 [Actual]
Last Update Submitted that Met QC Criteria2026-08-22
Last Update Posted2026-08-22 [Actual]

Oversight

U.S. FDA-regulated Drug
U.S. FDA-regulated Device
Product manufactured in and exported from the U.S.
Data MonitoringNo

Study Description

Brief SummaryThis trial compares HPV self-sampling with clinic-based visual inspection to improve cervical cancer screening uptake in community settings.
Detailed DescriptionEligible women are randomised to offered HPV self-sampling or standard clinic-based screening. The primary endpoint is screening uptake within three months of invitation.

Conditions

ConditionCervical Cancer Cancer Screening
Keywordscervical cancer HPV self-sampling screening

Study Design

Study TypeInterventional
Primary PurposeScreening
Study PhaseN/A
Interventional Study ModelParallel Assignment
Number of Arms2
MaskingNone (Open Label)
AllocationRandomized
Enrollment5200 [Estimated]

Arms and Interventions

ArmsAssigned Interventions
Experimental: HPV self-samplingDiagnostic Test: HPV self-sampling kit
Active Comparator: Clinic-based screeningProcedure/Surgery: Visual inspection with acetic acid

Outcome Measures

Primary Outcome MeasuresScreening uptake rate Time Frame: 3 months from invitation
Secondary Outcome MeasuresProportion referred for follow-up Time Frame: 6 months

Eligibility

Minimum Age30 Years
Maximum Age60 Years
Ages30 Years to 60 Years (Adult)
SexFemale
Gender-based Eligibility
Gender Eligibility Description
Accepts Healthy VolunteersYes
Criteria<p>Inclusion Criteria:</p><ul><li>Women aged 30 to 60 years not screened in the past three years.</li></ul><p>Exclusion Criteria:</p><ul><li>Prior hysterectomy.</li></ul>

Contacts/Locations

Central Contact PersonDr Rehana Begum +8802550000104 cervical-screen@bmu.ac.bd
Study Officials
LocationRajshahi, Rajshahi, Bangladesh, 6000 Status: Recruiting Facility: Rajshahi Medical College

IPD Sharing

IPD informationPlan to Share IPD: Not provided

References

Citations
Links
Available IPD/Information

Document Section

Documents