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Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators

NCT03139669 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-09-24

Study results available
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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.

Conditions

Interventions

DEVICE

Viba collection brush

HPV home collection kit using the viba collection brush to collect cervical cells for HPV DNA testing.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Emma Mitchell, PhD · Faculty

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-08-29
Completion
2019-08-29

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03139669 on ClinicalTrials.gov