Clinical trial · Interventional
Multilevel HPV Self-Testing Intervention for the Increase of Cervical Cancer Screening Among Women in Appalachia
A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening Among Women in Appalachia
NCT04411849CI-TRIAL-00094908completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates.
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 Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| HPV Self-Collection | Procedure | — | UNRESOLVED |
| Informational Intervention | Other | — | UNRESOLVED |
| Patient Navigation Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (intervention)
- description
- Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation.
- interventionNames
- Procedure: HPV Self-Collection
- Other: Informational Intervention
- Behavioral: Patient Navigation Program
- type
- ACTIVE_COMPARATOR
- label
- Group II (usual care continued)
- description
- Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.
- interventionNames
- Other: Best Practice
- Other: Informational Intervention
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Not within recommended cervical cancer screening guidelines for women in this age range (i.e., no Papanicolaou \[Pap\] test in last 3 years or no Pap test plus clinic-based HPV test in last 5 years) * Resident of an Appalachian county * Not currently pregnant * Intact cervix * No history of invasive cervical cancer * Seen in a participating clinic/health system in last 2 years (i.e., active patient) * Have a working telephone
References
Publications (0)
Data not yet available
No reference posted for this study.