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

UNC Lineberger Comprehensive Cancer Center

Status: Not yet enrolling

Conditions: Cervix Cancer; Screen HPV-positive

Treatments: Diagnostic Test: Human papilloma virus screening

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07294066

25-1747 Aim3

K23MD020429 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: Female

Ages: 30 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Woman

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Human papilloma virus screening

Community partners

No Intervention group

Description:

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.