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

NCT07294066 | Not Yet Recruiting DMC

• 2 other identifiers: 25-1747 Aim3K23MD020429
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervix Cancer; Screen HPV-positive

Keywords

Screening; rural; outreach; high risk

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Woman

EXPERIMENTAL

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

Community partners

NO INTERVENTION

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.

Interventions

Human papilloma virus screening DIAGNOSTIC_TEST

Human papilloma virus self-collection (HPVSC) kits will be provided to screen HPV.

Woman

Eligibility Criteria

• Age: 30 Years - 64 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• community health workers
• clinic staff
• community-based organization staff.
• None

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lisa Mansfield, PhD, RN

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Mansfield, PhD, RN

CONTACT

(919) 966-4260; lisa_mansfield@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 100 woman and 12 community partners will be enrolled.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 19, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.