# Project 3: A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening among Women in Appalachia

> **NIH NIH P01** · OHIO STATE UNIVERSITY · 2022 · $215,927

## Abstract

PROJECT SUMMARY – PROJECT 3 
Most cases of cervical cancer occur among unscreened and under screened women. Strategies to increase 
screening among these women, including HPV self-testing, have therefore been identified as the most 
important cervical cancer screening research priority. HPV self-testing involves women using a device to 
collect their own cervicovaginal sample for HPV testing. International studies have repeatedly shown that many 
unscreened and under screened women will use an HPV self-test at home and return it by mail, and recent 
efforts in the United States (US), including our own work, have established the feasibility of implementing such 
mail-based programs. An important next step in this field of research is to examine the effectiveness and 
implementation of a large, mail-based HPV self-testing program in the US. 
The overall goal of the proposed project is to determine the effectiveness and implementation of a multi-level 
cervical cancer screening intervention that features HPV self-testing for unscreened and under screened 
women from Appalachia, a region with longstanding cervical cancer disparities. The intervention will include 
mail-based HPV self-testing (patient-level), healthcare provider education sessions about HPV self-testing 
(provider-level), and patient navigation for women who do not initially return their HPV self-test or who 
subsequently test positive for a high-risk (i.e., oncogenic) HPV infection (system-level). The proposed study will 
include 1180 unscreened and under screened Appalachian women who are ages 30-64 and be implemented 
as part of the integrated health system-based cervical cancer prevention program “Improving Uptake of 
Cervical Cancer Prevention Services in Appalachia.” 
Importantly, the proposed project will take an effectiveness-implementation hybrid approach that will allow for 
the assessment of both intervention effectiveness and implementation. Specific aims will address each 
outcome type (service, implementation, and client outcomes) recommended for implementation research: Aim 
1 (service outcomes) will determine the effectiveness of the multi-level intervention in increasing cervical 
cancer screening (primary outcome); Aim 2 (implementation outcomes) will assess the acceptability, fidelity, 
sustainability, and cost-effectiveness of the intervention; and Aim 3 (client outcomes) will determine satisfaction 
with the intervention at the patient-, provider-, and system-level. Each aim will make a significant research 
contribution and, taken together, will be one of the most innovative and comprehensive HPV self-testing efforts 
to date in the US. As HPV self-testing continues to emerge as a cervical cancer screening strategy in the US, 
these findings will provide an evidence base on both intervention effectiveness and implementation that will be 
highly valuable in guiding future HPV self-testing programs and cervical cancer screening policies.

## Key facts

- **NIH application ID:** 10381632
- **Project number:** 5P01CA229143-04
- **Recipient organization:** OHIO STATE UNIVERSITY
- **Principal Investigator:** Paul L Reiter
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $215,927
- **Award type:** 5
- **Project period:** 2019-04-11 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10381632

## Citation

> US National Institutes of Health, RePORTER application 10381632, Project 3: A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening among Women in Appalachia (5P01CA229143-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10381632. Licensed CC0.

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