Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
Condition: Cervical Cancer; Uterine Cervical Neoplasms; Human Papillomavirus
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Screening invitation (with education); Self-collection for HPV testing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; 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.
Other intervention name(s): Screening recall; Client reminder; Self-testing; Self-sampling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Cervical cancer screening; HPV testing; Self-collection