Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3

Study Overview
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Brief Summary
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This study will investigate whether cervical cancer screening completion among under-screened women could be improved by offering HPV (human papillomavirus) testing by at-home self-collection followed by screening invitation compared to screening invitation alone.

Detailed Description
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Invasive cervical cancer (ICC) is preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals. More than half of ICC cases occur in these under-screened women. For women 30 years and older, the US Preventive Services Task Force recommends Pap smears alone every 3 years or physician-collected HPV testing with Pap smear (co-testing) every 5 years. The FDA approved primary HPV physician screening for US women 25 years and older. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection with comparable sensitivity and specificity to physician-collection for detecting high-grade cervical lesions. This 2-arm randomized control trial of 510 women will investigate whether offering HPV testing by mailed at-home self-collection to under-screened women increases their likelihood of completing cervical cancer screening. All participants will received a screening invitation by phone: a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free screening at a study-affiliated clinic, if needed. Those randomized to the intervention arm will first be mailed a kit to self-collect a cervico-vaginal sample, return the sample for oncogenic HPV testing, and receive their results by phone. HPV negative women will be considered screening complete. HPV positive women will be invited to schedule an appointment for free follow-up in-clinic screening in the same call in which their results are delivered. The study endpoint of screening completion will be defined as completing in-clinic screening (control arm participants and HPV positive intervention arm participants) or receiving a negative HPV self-collection result (intervention arm). Aim 1. Determine whether at-home HPV self-collection increases completion of cervical cancer screening among under-screened women offered enhanced reminders. Aim 2. Examine possible mechanisms explaining the intervention's effect, or lack of an effect. Aim 3. Estimate the incremental cost per additional woman completing screening of adding at-home HPV self-collection to enhanced reminders.

Official Title
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Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3

Conditions
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Cervical Cancer, Uterine Cervical Neoplasms, Human Papillomavirus

Intervention / Treatment
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* Behavioral: Screening invitation (with education)
* Behavioral: Self-collection for HPV testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Aged 25 to 64 years old Living at ≤250% of the federal poverty line Eligible to receive cervical cancer screening from a study-associated clinic Resides within the same or bordering county of a study-associated clinic Exclusion Criteria: Completion of cervical Pap screening in preceding 4 years Completion of HPV testing in preceding 6 years Pregnant History of hysterectomy Private insurance Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 25 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 |
| --- | --- |
| Active Comparator: Screening invitation (with education)<br>Participants will receive a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free cervical cancer screening at a study-affiliated clinic. | Behavioral: Screening invitation (with education)<br>* The participant will be provided with brief education about the importance and effectiveness of cervical cancer screening, and invited to schedule an appointment for a free in-clinic screening<br>* Other names: Client reminder;|
| Experimental: Self-collection for HPV testing<br>Participants in the intervention arm will receive a kit to self-collect a sample and return it for HPV testing. Participants will then receive a phone call providing their HPV results plus (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free cervical cancer screening at a study-affiliated clinic, if desired. | Behavioral: Screening invitation (with education)<br>* The participant will be provided with brief education about the importance and effectiveness of cervical cancer screening, and invited to schedule an appointment for a free in-clinic screening<br>* Other names: Client reminder;Behavioral: Self-collection for HPV testing<br>* Participant is provided with a kit to take a self-collected sample at home and return it by mail for HPV testing. Results are provided to participant by phone.<br>* Other names: Self-sampling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants that complete cervical cancer screening | Completion of cervical cancer screening is defined as (a) testing HPV negative by self-collection, or (b) completing in-clinic screening by i. HPV/Pap co-testing or ii. Pap smear alone. | Six months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of risk appraisal with regards to cervical cancer and screening | Risk appraisal will include multiple components measured by post-intervention questionnaire: Worry; Likelihood; Severity; Embodiment of risk (2 measures); Gist risk; Anticipated regret, action; Anticipated regret, inaction | 1-5 weeks after completion of self-collection or screening invitation | 
| Costs to payers | Incremental cost to payer (public or private) per additional woman screened | Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation) | 
| Level of intention to complete cervical cancer screening | As measured in post-intervention questionnaire | 1-5 weeks after completion of self-collection or screening invitation | 
| Level of self-efficacy to complete cervical cancer screening | As measured in post-intervention questionnaire | 1-5 weeks after completion of self-collection or screening invitation | 
| Percentage of participants who schedule a clinic appointment to get cervical cancer screening | Percent of participants that agree to schedule a clinic appointment to get a Pap smear or Pap/HPV co-testing | 1-5 weeks after completion of self-collection or screening invitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer screening, HPV testing, Self-collection