Multilevel HPV Self-Testing Intervention for the Increase of Cervical Cancer Screening Among Women in Appalachia

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-27

Study Completion Date

2024-06-11

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

Determine the effectiveness of the intervention in increasing cervical cancer screening.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: 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.

GROUP II: Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.

Conditions

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Cervical Carcinoma Human Papillomavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Group I (intervention)

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.

Group Type EXPERIMENTAL

HPV Self-Collection

Intervention Type PROCEDURE

Receive HPV self-testing intervention

Informational Intervention

Intervention Type OTHER

Receive information about cervical cancer

Patient Navigation Program

Intervention Type BEHAVIORAL

Receive telephone-based patient navigation

Group II (usual care continued)

Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care

Informational Intervention

Intervention Type OTHER

Receive information about cervical cancer

Interventions

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Best Practice

Receive usual care

Intervention Type OTHER

HPV Self-Collection

Receive HPV self-testing intervention

Intervention Type PROCEDURE

Informational Intervention

Receive information about cervical cancer

Intervention Type OTHER

Patient Navigation Program

Receive telephone-based patient navigation

Intervention Type BEHAVIORAL

Other Intervention Names

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standard of care standard therapy At-home HPV Self Collection HPV Self Collection Human Papillomavirus Self-Collection Patient Navigator Program

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes