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R01CA248558

Project Grant

Overview

Grant Description
Reducing Cervical Cancer Screening Disparities in Somali Immigrant Women through a Primary Care-Based HPV Self-Sampling Intervention - Summary/Abstract

Somali women living in the U.S. have lower cervical cancer screening rates than the U.S. general female population. This disparity is due to a range of factors, including limited awareness of HPV and cervical cancer, cultural and religious beliefs, mistrust of healthcare providers, concerns around modesty and circumcision, and low provider self-efficacy to perform Pap tests on circumcised women.

HPV self-sampling is an emerging cervical cancer screening modality that may address common screening barriers among Somali women, particularly those related to modesty and circumcision. HPV self-sampling is accurate for detecting pre-cancerous cervical lesions and effective in reaching underscreened women. In addition, our pilot work has demonstrated the feasibility and acceptability of HPV self-sampling in Somali women.

While research has focused primarily on home-based HPV self-sampling, there is an untapped opportunity to offer HPV self-sampling in the primary care setting. Offering HPV self-sampling in primary care could effectively increase cervical cancer screening rates in Somali women by positioning providers to address screening barriers, enabling clinics to opportunistically fit in HPV self-sampling with other appointments, and providing an alternative modality for circumcised women.

We propose a hybrid type 2 effectiveness-implementation design to assess the effectiveness and implementation of a patient-centered, culturally-tailored HPV self-sampling intervention for Somali women. Guided by the Consolidated Framework for Implementation Science and Social Cognitive Theory, we will conduct focus groups with Somali patients and interviews with providers to identify patient-, provider-, clinic-, and systems-level factors to inform refinement of intervention materials and development of implementation strategies (Aim 1).

After tailoring the intervention, we will then implement HPV self-sampling in 2 primary care clinics and evaluate changes in Somali women's cervical cancer screening rates one-year pre and one-year post-implementation (Aim 2). Changes will be compared with Somali women attending 27 control clinics followed over the same time period, using difference-in-difference methods.

Finally, using RE-AIM, we will conduct a post-implementation mixed methods analysis of the processes and strategies needed to successfully implement HPV self-sampling in primary care for Somali patients (Aim 3), including interviews with providers and Somali women. Our hypothesis is that implementing HPV self-sampling in primary care will lead to increased uptake of cervical cancer screening in Somali women and that an implementation science-based analysis of the processes needed to successfully implement the intervention will lead to sustainable, novel strategies to support the sustained integration of HPV self-sampling into primary care.
Funding Goals
TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS; (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION; (3) EPIDEMIOLOGY; (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS; (5) IMMUNOLOGY AND VACCINES; (6) FIELD STUDIES AND STATISTICS; (7) CANCER CHEMOPREVENTION AND INTERCEPTION; (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT; (9) ORGAN SITE STUDIES AND CLINICAL TRIALS; (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES; AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM; TO STIMULATE TECHNICAL INNOVATION; TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING; TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT; AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS; TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS; TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.
Place of Performance
Minneapolis, Minnesota 55414 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the End Date has been extended from 05/31/26 to 05/31/27 and the total obligations have increased 376% from $657,387 to $3,130,772.
Regents Of The University Of Minnesota was awarded HPV Self-Sampling to Reduce Cervical Cancer Disparities in Somali Women Project Grant R01CA248558 worth $3,130,772 from National Cancer Institute in June 2021 with work to be completed primarily in Minneapolis Minnesota United States. The grant has a duration of 6 years and was awarded through assistance program 93.393 Cancer Cause and Prevention Research. The Project Grant was awarded through grant opportunity Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required).

Status
(Ongoing)

Last Modified 4/20/26

Period of Performance
6/15/21
Start Date
5/31/27
End Date
87.0% Complete

Funding Split
$3.1M
Federal Obligation
$0.0
Non-Federal Obligation
$3.1M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01CA248558

Subgrant Awards

Disclosed subgrants for R01CA248558

Transaction History

Modifications to R01CA248558

Additional Detail

Award ID FAIN
R01CA248558
SAI Number
R01CA248558-2442214238
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75NC00 NIH National Cancer Institute
Funding Office
75NC00 NIH National Cancer Institute
Awardee UEI
KABJZBBJ4B54
Awardee CAGE
0DH95
Performance District
MN-05
Senators
Amy Klobuchar
Tina Smith

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Cancer Institute, National Institutes of Health, Health and Human Services (075-0849) Health research and training Grants, subsidies, and contributions (41.0) $1,390,813 100%
Modified: 4/20/26