Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina
NCT ID: NCT07294066
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
112 participants
INTERVENTIONAL
2026-01-31
2029-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
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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.
Human papilloma virus screening
Human papilloma virus self-collection (HPVSC) kits will be provided to screen HPV.
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.
No interventions assigned to this group
Interventions
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Human papilloma virus screening
Human papilloma virus self-collection (HPVSC) kits will be provided to screen HPV.
Eligibility Criteria
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Inclusion Criteria
* 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
* community health workers
* clinic staff
* community-based organization staff.
Exclusion Criteria
* history of cervical cancer,
* plan to move from Lenoir County during the study period.
Community partners participants
• None
30 Years
64 Years
FEMALE
Yes
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lisa Mansfield, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Central Contacts
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Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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25-1747 Aim3
Identifier Type: -
Identifier Source: org_study_id