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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
Trial Contacts
| ContactsICMJE | Dr Rehana Begum +8802550000104 cervical-screen@bmu.ac.bd |
|---|
Study Record Dates
| First SubmittedICMJE | Not provided |
|---|---|
| First PostedICMJE | 2026-07-18 |
| Last Update Posted | 2026-08-22 |
| Last Verified* | 2026-08 |
Outcome Measures
| Primary Outcome Measures*ICMJE | Screening uptake rate [Time Frame: 3 months from invitation] |
|---|---|
| Secondary Outcome Measures[*]ICMJE | Proportion referred for follow-up [Time Frame: 6 months] |
| Other Pre-specified Outcome Measures | Not provided |
Trial Description
| Brief Title*ICMJE | Screening Strategies for Cervical Cancer in Community Clinics |
|---|---|
| Official Title*§ICMJE | HPV Self-sampling Versus Clinic-based Visual Inspection to Improve Cervical Cancer Screening Uptake |
| Acronym[*] | HPV-SELF |
| Brief Summary* | This trial compares HPV self-sampling with clinic-based visual inspection to improve cervical cancer screening uptake in community settings. |
| Detailed Description | Eligible women are randomised to offered HPV self-sampling or standard clinic-based screening. The primary endpoint is screening uptake within three months of invitation. |
| Study Type*ICMJE | Interventional |
| Study Phase*ICMJE | N/A |
| Study Design*§ICMJE | Allocation: Randomized Interventional Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Screening |
| Condition*ICMJE | Cervical Cancer Cancer Screening |
| Keywords | cervical cancer HPV self-sampling screening |
| Intervention*ICMJE | Diagnostic Test: HPV self-sampling kit Procedure/Surgery: Visual inspection with acetic acid |
| Study Arms*ICMJE | Experimental: HPV self-sampling Interventions: Diagnostic Test: HPV self-sampling kit Active Comparator: Clinic-based screening Interventions: Procedure/Surgery: Visual inspection with acetic acid |
| Publications | Not provided |
Recruitment Information
| Recruitment Status*ICMJE | Recruiting |
|---|---|
| Enrollment (Anticipated)*§ICMJE | 5200 |
| Study Start Date*§ICMJE | 2026-07-20 |
| Primary Completion Date* | 2027-04-30 (Final data collection date for primary outcome measure) |
| Study Completion Date*§ICMJE | 2027-07-31 |
| Eligibility Criteria*ICMJE | <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> |
| Sex/Gender*ICMJE | Sexes Eligible for Study: Female |
| Ages*ICMJE | 30 Years to 60 Years (Adult) |
| Accepts Healthy Volunteers*§ICMJE | Yes |
| Location CountriesICMJE | Bangladesh |
Administrative Information
| BDCTR NumberICMJE | BDCTR-2026-000104 |
|---|---|
| Other Study ID Numbers[*]ICMJE | BMU-ONC-2026-003 |
| Has Data Monitoring Committee | No |
| Studies a U.S. FDA-regulated Drug Product | Not provided |
| Studies a U.S. FDA-regulated Device Product | Not provided |
| Device Product Not Approved or Cleared by U.S. FDA | Not provided |
| Pediatric Postmarket Surveillance of a Device Product | Not provided |
| Product Manufactured in and Exported from the U.S. | Not provided |
| IPD Sharing StatementICMJE | Plan to Share IPD: Not provided |
| Current Responsible Party* | Dr Rehana Begum |
| Current Study Sponsor*ICMJE | Bangladesh Medical University |
| CollaboratorsICMJE | Not provided |
| InvestigatorsICMJE | Not provided |
| Registry Account | Imported legacy public registry |
Symbol Legend
- *
- Required
- *§
- Required if Study Start Date is on or after January 18, 2017 — required for every BMU study
- [*]
- Conditionally required
- No Symbol
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- ICMJE
- Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP