Clinical trial · Interventional
Randomized Trial of Vaginal Self Sampling for Human Papillomavirus (HPV)
Randomized Controlled Trial of Vaginal Self Sampling for Human Papillomavirus to Increase Cervical Cancer Screening Participation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Up to 30% of Canadian women do not participate in Pap smear screening for cervical cancer prevention despite many being members of family practices and having access to family physicians. One reason is reluctance to undergo pelvic examination. The investigators purpose is to determine whether the offer of vaginal self sample collection for oncogenic human papillomavirus (HPV) testing increases participation in cervical cancer screening compared to repeat reminder for Pap smear testing among female family practice members who have not previously responded to invitations for Pap testing.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2nd reminder letter for Pap testing | Other | — | UNRESOLVED |
| offer of vaginal self collection | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 2nd Reminder Letter
- description
- 50% of study participants who are overdue for Pap testing and do not respond to initial reminder letter will be be mailed a standard second reminder letter
- interventionNames
- Other: 2nd reminder letter for Pap testing
- type
- EXPERIMENTAL
- label
- Offer of Vaginal Self Collection
- description
- 50% of study participants who are overdue for Pap testing and do not respond to initial reminder letter will be selected to be mailed a second reminder letter and offer of vaginal self collection
- interventionNames
- Device: offer of vaginal self collection
- Other: 2nd reminder letter for Pap testing
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * members of consenting family physicians identified through OSCAR EMR * overdue for Pap smear testing * have not presented for Pap smear screening after 1 reminder letter Exclusion Criteria: * currently attending colposcopy clinic * institutionalized * without a cervix
References
Publications (0)
Data not yet available