N/A
N=45
Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators
Human Papilloma Virus
Bottom Line
View on ClinicalTrials.gov: NCT03139669 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Acceptability of At-home Self-collection for HPV Testing Among Under-screened Women in Southwest Virginia. — 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Viba collection brush (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- University of Virginia
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of At-home Self-collection for HPV Testing Among Under-screened Women in Southwest Virginia. |
45 | — |
| SECONDARY Feasibility of Utilizing Lay Navigators to Offer At-home HPV Self-collection as a Strategy to Increase Cervical Cancer Screening Among Under-screened Women in Southwest Virginia. |
42; 3 | — |
Summary
Invasive cervical cancer incidence and mortality can be dramatically reduced through early detection and treatment, but many women do not complete screening at recommended intervals. Many low-income women in Virginia remain uninsured and are at significant risk of being medically underserved and failing to complete regular cervical cancer screening. At-home self-collection of specimens for HPV testing is an innovative approach that may increase access to cervical cancer screening in populations that do not participate in traditional clinic-based screening. The proposed community based participatory study aims to determine whether offering at-home self-collection for HPV testing through a lay navigator network is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in the Tobacco Footprint in rural far Southwest Virginia (Health Districts 1, 2 and 3). The procedures will be recruitment of under-screened women in Health Districts 1, 2 and 3 of Southwest Virginia to complete HPV testing using self-collection kits distributed by lay navigators. Regardless of HPV positivity, all women will be provided with information about cervical cancer screening (locations, cost, etc.), and will be encouraged to complete Pap screening by a clinician.
Eligibility Criteria
Inclusion Criteria
- 30-65 years old
- Female
- Live in southwest VA
- Not pregnant-self reported
Exclusion Criteria
- History of Papanicolaou test in the last 3 years
- History of hysterectomy or pelvic radiation
- Co-testing (pap test and HPV test at the same time) in the last 5 years
- English speaking
Data sourced from ClinicalTrials.gov (NCT03139669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.