Cervix CancerNCT07294066
Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina
A study testing Human papilloma virus screening in people with Cervix Cancer and Screen HPV-positive, run by UNC Lineberger Comprehensive Cancer Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix Cancer, Screen HPV-positive
- What is being tested?
- Human papilloma virus screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- community health workers
- clinic staff
- community-based organization staff.
Who cannot join
- 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
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervix Cancer, Screen HPV-positive
- Being tested
- Human papilloma virus screening
- Keywords
- Screening, rural, outreach, high risk
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human papilloma virus screeningDiagnostic test
Human papilloma virus self-collection (HPVSC) kits will be provided to screen HPV.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and enrollment rate
Proportion of eligible unscreened women recruited, with a target enrollment of 100 participants from Lenoir County.
Measured: 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.
Measured: Up to 6 months
HPV positive screening rate
Rate of HPV-positive screening rate among woman started study will be reported.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startSep 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 100 woman and 12 community partners will be enrolled.
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Lisa Mansfield, PhD, RN, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294066
- Sponsor's protocol ID
- 25-1747 Aim3
- Other IDs
- K23MD020429
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina Aim 3
- ClinicalTrials.gov ID
- NCT07294066
- Acronym / sponsor ID
- 25-1747 Aim3
- Conditions
- Cervix Cancer, Screen HPV-positive
- Keywords
- Screening, rural, outreach, high risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 100 woman and 12 community partners will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Woman | Experimental | Diagnostic Test: Human papilloma virus screeningWomen 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. |
| 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. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- community health workers
- clinic staff
Key exclusion criteria (5 listed)
- 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
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human papilloma virus screeningHuman papilloma virus self-collection (HPVSC) kits will be provided to screen HPV. | Diagnostic test | Woman |
Primary outcome
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.
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.
HPV positive screening rate
Time frame: Up to 6 months
Rate of HPV-positive screening rate among woman started study will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Mansfield, PhD, RN principal investigator
UNC Lineberger Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Human papilloma virus screening in people with Cervix Cancer and Screen HPV-positive, run by UNC Lineberger Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Mansfield, PhD, RN ((919) 966-4260, lisa_mansfield@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and enrollment rate (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.