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NCT Number: NCT07294066

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

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.

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Key information

Conditions

Cervix Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Screen HPV-positive Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human papilloma virus screening

Diagnostic Test

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

Primary outcomes

  1. Recruitment and enrollment rate

    Time frame: Up to 6 months

    Proportion of eligible unscreened women recruited, with a target enrollment of 100 participants from Lenoir County.

  2. Retention rate

    Time frame: Up to 6 months

    Ratio of returned HPV self-collection kits to kits distributed, and rate of participant withdrawal or loss to follow-up.

  3. HPV positive screening rate

    Time frame: Up to 6 months

    Rate of HPV-positive screening rate among woman started study will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Mansfield, PhD, RN

CONTACT

[email protected]

(919) 966-4260

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 19, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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