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

Study Overview
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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.

Detailed Description
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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.

Official Title
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A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening Among Women in Appalachia

Conditions
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Cervical Carcinoma, Human Papillomavirus Infection

Intervention / Treatment
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* Other: Best Practice
* Procedure: HPV Self-Collection
* Other: Informational Intervention
* Other: Medical Chart Review
* Behavioral: Patient Navigation Program
* Other: Survey Administration


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (early intervention)<br>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. | Procedure: HPV Self-Collection<br>* Receive HPV self-testing intervention<br>* Other names: Human Papillomavirus Self-Collection;Other: Informational Intervention<br>* Receive information about cervical cancer<br>Other: Medical Chart Review<br>* Ancillary studies<br>* Other names: Chart Review;Behavioral: Patient Navigation Program<br>* Receive telephone-based patient navigation<br>* Other names: Patient Navigator Program;Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (delayed intervention)<br>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. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Procedure: HPV Self-Collection<br>* Receive HPV self-testing intervention<br>* Other names: Human Papillomavirus Self-Collection;Other: Informational Intervention<br>* Receive information about cervical cancer<br>Other: Medical Chart Review<br>* Ancillary studies<br>* Other names: Chart Review;Behavioral: Patient Navigation Program<br>* Receive telephone-based patient navigation<br>* Other names: Patient Navigator Program;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of human papillomavirus (HPV) intervention | 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). | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equitableness of HPV intervention | 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). | Up to 5 years | 
| Safety of HPV intervention | Will descriptively examine data from the patient satisfaction survey to see if women report any issues about using their HPV self-test. | Up to 5 years | 
| Fidelity of HPV intervention | Will develop an electronic tracking system to track all mailings (e.g., self-test distribution) and other data collection activities. | Up to 5 years | 
| Sustainability of HPV intervention | Will examine the screening rates during the Sustainability phase(s) for both Groups 1 and 2 to determine sustainability. | Up to 5 years | 
| Cost-effectiveness of HPV intervention | Cost-effectiveness analyses will be conducted from a payer perspective. | Up to 5 years | 
| Satisfaction with HPV self-testing and PN | 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.). | Up to 5 years | 
| Satisfaction with provider education sessions | 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. | Up to 5 years |