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

A Multilevel HPV Self-Testing Intervention to Increase 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.

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.

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.

The patient-level effectiveness will be whether or not women get "screened" during the project. Will examine the proportion of women from year 2 screened, and use an intent-to-treat approach. To compare treatment groups (Group 1 versus Group 2), will use generalized linear mixed models (GLMMs) to account for the correlation between women from the same clinic. Will examine the proportion of HPV self-test returners who returned their self-test following receipt of patient navigation (PN). Will use GLMMs with a logit link to examine potential differences in the proportion of women screened across project years within each treatment group (i.e., comparing years 2, 3, 4, and 5 for Group 1).

To assess if the intervention is equitable, will examine patient characteristics. Will use GLMMs with a logit link to examine if patient characteristics are associated with women being categorized as "screened". Participant characteristics will primarily be demographic characteristics (e.g., age).

Will descriptively examine data from the patient satisfaction survey to see if women report any issues about using their HPV self-test.

Will develop an electronic tracking system to track all mailings (e.g., self-test distribution) and other data collection activities.

Will examine the screening rates during the Sustainability phase(s) for both Groups 1 and 2 to determine sustainability.

Patient-level satisfaction data will come from the patient satisfaction surveys sent to women. Will examine satisfaction with both the HPV self-test device (appearance, usability, return process, etc.) and its instructions (appearance, readability, etc.).

Provider-level satisfaction data will come from the post-test surveys from provider education sessions. All satisfaction items will use 5-point Likert response scales.

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