The Self-Testing options in the Era of Primary HPV screening for cervical cancer (STEP) trial will evaluate
effectiveness of home-based human papillomavirus (HPV) kits for improving cervical cancer screening uptake,
cost-effectiveness, and patient and provider experience. STEP is timely in response to 2018 US Preventive
Services Task Force cervical cancer screening guidelines, which include HPV testing alone (i,e., primary HPV
screening) as a newly recommended option for women aged 30-65 years. Because HPV testing can be
performed on clinician- or patient-collected samples (unlike Pap tests), primary HPV screening allows home-
based screening options–a potential game changer for delivery of cervical cancer screening. US healthcare
systems are keenly interested in identifying cost-effective outreach and patient-centered approaches to reverse
declining rates of adherence to guideline-recommended cervical cancer screening. Our central hypotheses are
that offering home-based HPV self-collection will increase screening participation, be preferred by women, be
cost-effective, and not reduce uptake of other preventive services despite removal of in-clinic screening
appointments. We propose a pragmatic randomized controlled trial among 19,026 women ages 30-65 years at
Kaiser Permanente Washington who are due for routine cervical cancer screening (oversampling
underrepresented minorities) that will compare three outreach approaches: Usual Care (standard patient
education and reminders for in-clinic screening); Direct Mail (mailed a home HPV testing kit with information
on why it is offered and recommended follow-up for different results); or Opt-In (same information as the direct
mail arm with instructions on how to request an HPV kit). Randomization allocation will vary among 3 target
populations defined by a woman's prior screening behavior: 1) screening adherent (due now or in the next 12
months); 2) overdue (≥6 months past due); and 3) unknown (no recorded screening and recently enrolled).
Primary outcomes are screening uptake within 6 months (Aim 1) and cost-effectiveness (Aim 2). Secondary
outcomes include: the proportion of women who complete recommended in-clinic follow-up after a positive kit
result, uptake of other recommended preventive services (subaim 1), patient and provider preferences about
home HPV screening, and facilitators and barriers to follow-up of abnormal results (Aim 3). STEP will be the
first US trial to evaluate adherence and cost-effectiveness of different approaches for offering HPV self-
sampling for cervical cancer screening. Surveys and in-depth interview data from women and providers will be
used with the main trial data to deepen understanding of patient and provider experience with home-based
HPV testing. Our trial has tremendous translational potential to improve cervical cancer screening and enable
women to receive screening aligned with their preferences. It is timely and directly responsive to calls from US
guideline committees to evaluate the effect of HPV self-sampling strategies on screening coverage and follow-
up adherence, with the goal of preventing cervical cancer incidence and mortality.
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