St. Joe's Invitation Effectiveness Study
Condition: Cervical Cancer Screening
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the effectiveness of offering self-sampling for
      high risk human papilloma virus (HPV) testing in order to increase the number of women who
      are screened for cervical cancer. The hypothesis of this study is that women who are notified
      of a need for cervical cancer screening by letter and are also offered a self-sampling kit
      for cervical cancer screening will have a higher rate of screening than women notified by
      letter alone.

      This study will use an intervention arm (letter and option to request a self-sampling kit)
      compared to a control arm (letter alone, standard of care) as a reminder that they are out of
      date for their cervical cancer screening. Women who are out of date with their cervical
      cancer screening will be identified using the Electronic Medical Record and randomized to the
      study group in a 2 to 1 ratio (2 for the control arm and 1 to the intervention arm). The
      primary endpoint that will be evaluated in this study is the method of completion of cervical
      cancer screening and the use of the self-sampling kit, which will be monitored over a three
      month period after the letters have been mailed. A secondary endpoint will be the overall
      rate of cervical cancer screening of all people mailed a letter.
    

Detailed description: 
      The American Cancer Society estimates that 4,170 women in the United States will die from
      cervical cancer in 2018. It is possible to prevent many of these deaths through screening and
      appropriate follow-up in women with positive screens (1). Self-sampling for HPV testing may
      be a viable option for cervical cancer screening, particularly among women who do not obtain
      regular screening in a clinical setting.

      The objective of this study is to evaluate the effectiveness of offering self-sampling for
      high risk HPV testing to in order to increase the number of women who are screened for
      cervical cancer at the Penn State Health (PSH) St. Joseph's family and community medicine
      residency clinic. This study will use an intervention arm and a control arm. Women in the
      control arm will receive a standard letter stating that they need to be screened and should
      contact their primary care provider. Women in the intervention arm will receive a modified
      version of the letter informing them of a self-sampling option with a pre-addressed post card
      that allows them to request a self-sampling kit. Once the postcard is returned these women
      will receive a self-sampling kit in the mail to collect their sample. The kit will come with
      a pre-paid mailer so that the participant can return their kit for processing at the Penn
      State Hershey Clinical laboratory.

      Women who are out of date with their cervical cancer screening will be identified using the
      Electronic Medical Record by the use of a set of queries that have been developed to extract
      this patient population. Eligible women will be randomized to the study group in a 2 to 1
      ratio (2 for the control arm and 1 to the intervention arm). The primary endpoint that will
      be evaluated in this study is the method of completion of cervical cancer screening and the
      use of the self-sampling kit, which will be monitored over a three month period after the
      letters have been mailed. A secondary endpoint will be the overall rate of cervical cancer
      screening of all people mailed a letter. Participants will be recruited continuously until
      the anticipated sample size has been met. A total of 1,211 participants are expected to
      participate in this study, 807 in the control arm and 404 in the intervention arm. The study
      team will calculate the proportion of participants who obtain cervical cancer screening from
      the clinic or the self-sampling kit and use chi-square tests for statistical analysis.

      If a self-collected cervical sample produces a negative result, the participant will be
      contacted by a study physician with these results. If the sample produces a positive result
      for low-risk HPV the participant will be contacted by a study physician to schedule a pap
      test. If the sample produces a positive result for high-risk HPV the participant will be
      contacted by a study physician for a colposcopy. The pap test and colposcopy are both
      standard of care for these results. The study team will monitor the completion of the
      screenings and subsequent procedures.
    

Intervention name(s): Evalyn Self-Sampling Brush
Intervention type(s): Device
Intervention description(s): A self-sampling brush to collect cervical cancer cells for screening purposes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will use a two armed model: an intervention and a control arm. The control arm will use a standard of care letter reminding the participant to schedule their screening with their primary care provider. The intervention arm will consist of a modified letter with a postcard giving the participant the option to request a self-sampling kit.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Cervical Cancer; Self-Sampling