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

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

 II. Assess the fidelity, sustainability, and cost-effectiveness of the intervention.

 III. Determine satisfaction with the intervention at the patient- and provider-levels.

 OUTLINE: Participants are randomized to 1 of 2 groups.

 GROUP I: During year 2, 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. Participants then complete a satisfaction survey and have their medical
 record reviewed. During years 3-5, this intervention is repeated among women who remain
 unscreened/underscreened.

 GROUP II: During year 2, participants receive usual care consisting of a reminder letter to
 get a clinic-based cervical cancer screening test and information about cervical cancer.
 During years 3-5, participants receive the HPV self-testing intervention described for Group
 I.
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