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

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.

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 5 years

- Pregnant

- History of hysterectomy

- Private insurance

- Unable to provide informed consent