Trial Summary

The 29.3 million patients receiving care in US federally qualified health centers (FQHCs) have much lower cervical cancer screening rates than the national average. Self-collect for human papillomavirus (HPV) testing is an evidence-based cervical cancer screening method with high potential to reduce screening barriers. Self-collect kits can be distributed at clinics or mailed to patients’ homes. Despite recent FDA approvals, FQHCs face significant barriers to implementing HPV self-collect. The STEP-2 trial will evaluate multilevel interventions for integrating HPV self-collect into FQHCs that leverage FQHC-Medicaid partnerships. In the planning phase, the study team will use community-engaged research and stakeholder input to adapt and pilot test multilevel interventions to support distribution of HPV self-collect kits in clinic and by mail. In the implementation phase, the study team will conduct a cluster randomized pragmatic trial to compare the effectiveness of the interventions for increasing cervical cancer screening. At least 42 FQHC clinics in Washington will be randomly allocated to 3 arms: usual care, in-clinic HPV self-collect distribution, or in-clinic plus mailed kit distribution. The mailed component will be administered by 2 Medicaid health plans. The primary outcome is the proportion of eligible patients who complete screening. The 2 primary comparisons will be usual care vs in-clinic distribution and in-clinic distribution vs in-clinic plus mail distribution. To minimize bias, each comparison will include distinct but overlapping patient populations (for example, all patients seen in clinic, Medicaid enrollees who established care with the clinic). 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 Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework and the Practical Implementation Sustainability Model (PRISM) to evaluate the interventions 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-collect for increasing cervical cancer screening in FQHC settings. Results of the study will inform broad-scale implementation of HPV self-collect across FQHCs and other safety net clinics in the United States to reduce disparities in cervical cancer screening.

NIH Project Information