Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-25 @ 2:28 PM
Study NCT ID:
NCT07294066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina Aim 3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23MD020429 | NIH | None | https://reporter.nih.gov/quic… | View |