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Self-Testing for Cervical Cancer in Priority Populations: the STEP-2 Trial

Award Number: UG3CA290286
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2024
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Self-Testing for Cervical Cancer in Priority Populations: the STEP-2 Trial - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $651,929 )
2025	2025	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Cancer Cause and Prevention Research	001	2	5/22/2025	NON-COMPETING CONTINUATION	$65,192
2025	2025	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Cancer Cause and Prevention Research	000	2	4/8/2025	NON-COMPETING CONTINUATION	$586,737
														Subtotal = $651,929

Issue Date FY: 2024 ( Subtotal = $705,051 )
2024	2024	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Cancer Cause and Prevention Research	000	1	5/15/2024	NEW	$705,051
														Subtotal = $705,051

Grand Total All Awards = $1,356,980

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Self-Testing for Cervical Cancer in Priority Populations: the STEP-2 Trial

Award Number: UG3CA290286

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/15/2024

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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