Abstract
BackgroundScreening substantially reduces cervical cancer incidence and mortality. More than half of invasive cervical cancers are attributable to infrequent screening or not screening at all. The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening.Methods/designThe study will enroll at least 510 US women aged 25–64 years who report no Pap test in the last 4 years and no HPV test in the last 6 years. We will randomize participants to an intervention or control arm. The intervention arm will receive kits to self-collect a sample at home and mail it for HPV testing. In both the intervention and control arms, participants will receive assistance in scheduling an appointment for screening in clinic. Study staff will deliver HPV self-collection results by phone and assist in scheduling participants for screening in clinic. The primary outcome is completion of cervical cancer screening. Specifically, completion of screening will be defined as screening in clinic or receipt of negative HPV self-collection results. Women with HPV-negative self-collection results will be considered screening-complete. All other participants will be considered screening-complete if they obtain co-testing or Pap test screening at a study-affiliated institution or other clinic. We will assess whether the self-collection intervention influences participants’ perceived risk of cervical cancer and whether perceived risk mediates the relationship between HPV self-collection results and subsequent screening in clinic. We also will estimate the incremental cost per woman screened of offering at-home HPV self-collection kits with scheduling assistance as compared to offering scheduling assistance alone.DiscussionIf mailed self-collection of samples for HPV testing is an effective strategy for increasing cervical cancer screening among women overdue for screening, this method has the potential to reduce cervical cancer incidence and mortality in medically underserved women at higher risk of developing cervical cancer.Trial registrationClinicalTrials.gov NCT02651883, Registered on 11 January 2016.
Highlights
Screening substantially reduces cervical cancer incidence and mortality
If mailed self-collection of samples for human papillomavirus (HPV) testing is an effective strategy for increasing cervical cancer screening among women overdue for screening, this method has the potential to reduce cervical cancer incidence and mortality in medically underserved women at higher risk of developing cervical cancer
The US studies published to date that have assessed screening completion from HPV self-collection have used self-collection as their primary endpoint, independent of follow up to screening in clinic among selftest, HPV-positive women [17, 43]. In this Randomized controlled trials (RCTs) we will determine whether offering at-home self-collection of samples for HPV testing increases the completion of cervical cancer screening among under-screened women compared to offering clinic scheduling assistance alone
Summary
Screening substantially reduces cervical cancer incidence and mortality. More than half of invasive cervical cancers are attributable to infrequent screening or not screening at all. Randomized controlled trials (RCTs) and population-level studies from the USA and Sweden show that offering client reminders with appointment scheduling assistance is effective for increasing screening rates in clinic compared to usual care (i.e., no reminders or appointment scheduling assistance) [9,10,11,12] Strategies such as mail or phone call reminders have been shown to be less effective or ineffective in increasing cervical cancer screening rates among women who have to take time off work to attend an appointment, have limited transportation options, feel physical discomfort or embarrassment with pelvic examinations, or are not actively participating in a healthcare system [4, 11, 13]
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