Grant Number:	1UG3CA290286-01 Interpret this number
Primary Investigator:	Winer, Rachel
Organization:	University Of Washington
Project Title:	Self-Testing for Cervical Cancer in Priority Populations: the Step-2 Trial
Fiscal Year:	2024

PROJECT SUMMARY/ABSTRACT The 29.3 million patients receiving care in US Federally Qualified Health Centers (FQHCs) have much lower cervical cancer screening rates than national averages: Only 53% of eligible patients were up-to-date in 2021 and the COVID-19 pandemic exacerbated these disparities. Self-sampling for human papillomavirus (HPV) is an evidence-based cervical cancer screening method with high potential to reduce screening barriers. Self- sampling kits can be distributed at clinics or mailed to patients' homes. Despite widespread international adoption, HPV self-sampling is nascent in the US. Little data is available to inform implementing this preventive service in low-resource settings such as FQHCs. Our two-phase pilot and pragmatic trial will adapt and evaluate two programs to integrate HPV self-sampling into FQHCs. Our trial accounts for the context, capacity and resources of FQHCs, and leverages FQHC-Medicaid partnerships to promote this preventive care service. Phase 1 will be a milestone-driven planning phase. We will use community-based participatory research and stakeholder input to adapt and pilot-test 2 multilevel interventions in 2 FQHCs for distributing HPV self- sampling kits: in clinics and in clinics plus direct mailing. Phase 2 will be a cluster-randomized pragmatic trial in 42 Oregon and Washington FQHC clinics to evaluate the comparative effectiveness and cost-effectiveness of the interventions. Clinics will be randomized to Usual Care (UC), in-clinic distribution (Clinic Only), or in-clinic plus mailed distribution (Clinic + Mail). For in-clinic distribution, providers will offer self-sampling at in-person or telehealth encounters. The mailed component will be administered by Medicaid health plans. The primary outcome is the proportion of eligible patients (30-64 years, due/overdue for routine screening) who complete screening. Co-primary comparisons are (1) UC vs Clinic Only and (2) Clinic Only vs Clinic + Mail. To minimize bias, each comparison includes distinct but overlapping patient populations. Comparison 1 includes all patients (Medicaid and non-Medicaid) with a clinic encounter during the 12-month study period. Comparison 2 is restricted to Medicaid patients who are enrolled with the clinic, but does not require a clinic encounter during the 12-month study period. Cost-effectiveness will compare the Clinic Only HPV self-sampling intervention relative to UC, and Clinic + Mail relative to Clinic Only. We will use the RE-AIM framework and PRISM to assess provider, clinic and health plan acceptability and evaluate adaptations to the implementation strategies through mixed methods. Our pragmatic trial will be the first in the US to determine the effectiveness and cost- effectiveness of HPV self-sampling for increasing cervical cancer screening in FQHC settings. Results from our comparisons and evaluation of implementation strategies will inform broad-scale implementation of HPV self- sampling across FQHCs and other safety-net clinics in the US to reduce cervical cancer screening disparities.





None