Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina

Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina Aim 3

The purpose of this study is to test the feasibility and acceptability of a multi-level, community-engaged intervention to increase access to cervical cancer screening using human papillomavirus (HPV) self-collection (HPVSC) outreach among women living in a high-risk rural county and to improve navigation for follow-up screening.

A one-group intervention evaluation design will be used to pilot test feasibility and acceptability and to assess the proportion of women who return HPVSC kits and test HPV-positive. At the community level, local community-based organizations (CBOs) will serve as HPVSC kit distribution sites. At the individual level, trained community health workers will work with CBOs to support women throughout the HPVSC process, including specimen collection, kit return, result notification, and follow-up clinic-based screening for women who test HPV-positive.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervix Cancer; Screen HPV-positive
• Intervention / Treatment: Diagnostic test: Human papilloma virus screening

Detailed Description

The RE-AIM framework will be applied to selected domains to assess feasibility using predefined parameters. Quantitative surveys will measure acceptability of intervention components among women and community partners, and qualitative interviews will explore their experiences with the intervention.

The RE-AIM framework is a comprehensive tool for evaluating public health and community-based interventions. It focuses on five key dimensions: Reach, which assesses the number, proportion, and representativeness of individuals who participate in a program; Effectiveness, which measures the impact of the intervention on important outcomes, including potential negative effects; Adoption, which examines the number and representativeness of settings or staff that implement the program; Implementation, which evaluates how well the intervention is delivered as intended, including consistency and costs; and Maintenance, which considers the sustainability of both the intervention and its effects over time at individual and organizational levels.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Mansfield, PhD, RN; Phone Number: (919) 966-4260; Email: lisa_mansfield@unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Woman participants

Inclusion Criteria:

• Resident of Lenoir County and 12 community.
• have not received a Pap test within the last 3.5 years, or an HPV test in the last 5.5 years
• female ≥ 30 to 64 years of age at time of recruitment

Exclusion Criteria:

• 65 years of age or older had a hysterectomy,
• history of cervical cancer,
• plan to move from Lenoir County during the study period.

Community partners participants

Inclusion Criteria:

• community health workers
• clinic staff
• community-based organization staff.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Woman; Women living in Lenoir County will receive HPV self-collection with navigation. At the community level, local community-based organizations (CBOs) will serve as human papillomavirus self-collection (HPVSC) kit distribution sites for unscreened or under screened women.	Diagnostic test: Human papilloma virus screening; Human papilloma virus self-collection (HPVSC) kits will be provided to screen HPV.
No Intervention: Community partners; Twelve community partners involved in delivering various components of the intervention (e.g., distributing self-collection kits, providing navigation to follow-up care, or providing clinic-based screening for follow-up for HPV positive tests) will complete surveys and interviews to provide feedback about the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment and enrollment rate	Proportion of eligible unscreened women recruited, with a target enrollment of 100 participants from Lenoir County.	Up to 6 months
Retention rate	Ratio of returned HPV self-collection kits to kits distributed, and rate of participant withdrawal or loss to follow-up.	Up to 6 months
HPV positive screening rate	Rate of HPV-positive screening rate among woman started study will be reported.	Up to 6 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Lisa Mansfield, PhD, RN, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Screening; high risk; rural; outreach
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: 25-1747 Aim3; K23MD020429 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) generated from this study will be made publicly available. Data will be shared via unrestricted download, with no controlled access. No limitations are anticipated on data access, distribution, or reuse. All shared data will be de-identified to protect participant confidentiality and will be collected and shared in accordance with informed consent, IRB approval, and UNC Research Compliance Program policies.
• IPD Sharing Time Frame: No later than the time of publication or the end of the funding period, whichever occurs first, and will be preserved for a minimum of 10 years.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No