Trial Summary

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 United States. Little data is available to inform implementing this preventive service in low-resource settings such as FQHCs.

This 2-phase pilot study and pragmatic clinical trial will adapt and evaluate 2 programs to integrate HPV self-sampling into FQHCs. The trial will account for the context, capacity, and resources of FQHCs and will leverage FQHC-Medicaid partnerships to promote this preventive care service. Phase 1 will be a milestone-driven planning phase. The study team will use community-engaged research and stakeholder input to adapt and pilot-test 2 multilevel interventions in 2 FQHCs for distributing HPV self-sampling kits: in-clinic distribution and in-clinic plus mailed distribution. Phase 2 will be a cluster randomized pragmatic trial in 42 FQHC clinics in Oregon and Washington to evaluate the comparative effectiveness and cost-effectiveness of the interventions. Clinics will be randomly assigned to usual care, in-clinic distribution of self-sampling kits, or in-clinic plus mailed distribution. For in-clinic distribution, providers will offer self-sampling at in-person or telehealth encounters. The mailed component will be administered by 3 Medicaid health plans. The primary outcome is the proportion of eligible patients (aged 30 to 64 years and due or overdue for routine screening) who complete screening. Two primary comparisons will be (1) usual care vs in-clinic distribution and (2) in-clinic distribution vs in-clinic plus mail distribution. To minimize bias, each comparison will include distinct but overlapping patient populations. Comparison 1a will include all patients (Medicaid and non-Medicaid beneficiaries) with a clinic encounter during the 12-month study period. Comparison 1b will be restricted to Medicaid beneficiaries who are enrolled with the clinic but will not require a clinic encounter during the 12-month study period. A cost-effectiveness analysis will compare in-clinic distribution vs usual care and in-clinic plus mail distribution vs in-clinic distribution alone. The study team will use the RE-AIM and PRISM framework to evaluate the implementation strategies through mixed methods.

The STEP-2 trial will be the first in the United States to determine the effectiveness and cost-effectiveness of HPV self-sampling for increasing cervical cancer screening in FQHC settings. Results from the comparisons and evaluation of implementation strategies will inform broad-scale implementation of HPV self-sampling across FQHCs and other safety net clinics in the United States to reduce disparities in cervical cancer screening.

NIH Project Information