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

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

Sponsors

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Collaborator: National Cancer Institute (NCI)

Source UNC Lineberger Comprehensive Cancer Center
Brief Summary

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

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.

Overall Status Active, not recruiting
Start Date 2016-04-01
Completion Date 2021-01-01
Primary Completion Date 2021-01-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent of participants that complete cervical cancer screening Six months after enrollment
Secondary Outcome
Measure Time Frame
Levels of risk appraisal with regards to cervical cancer and screening 1-5 weeks after completion of self-collection or screening invitation
Costs to payers 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 1-5 weeks after completion of self-collection or screening invitation
Level of self-efficacy to complete cervical cancer screening 1-5 weeks after completion of self-collection or screening invitation
Percentage of participants who schedule a clinic appointment to get cervical cancer screening 1-5 weeks after completion of self-collection or screening invitation
Enrollment 510
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Screening invitation (with education)

Description: 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

Intervention Type: Behavioral

Intervention Name: Self-collection for HPV testing

Description: 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.

Arm Group Label: Self-collection for HPV testing

Eligibility

Criteria:

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

Gender:

Female

Minimum Age:

25 Years

Maximum Age:

64 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jennifer S Smith, PhD Principal Investigator UNC Chapel Hill
Location
Facility: University of North Carolina Gillings School of Public Health
Location Countries

United States

Verification Date

2020-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Screening invitation (with education)

Type: Active Comparator

Description: 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.

Label: Self-collection for HPV testing

Type: Experimental

Description: 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.

Acronym MBMT-3
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Screening

Masking: None (Open Label)

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