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Not yet recruiting NCT07294066

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

No phase Interventional Cervix Cancer Screen HPV-positive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Human papilloma virus screening.
Who it may be relevant to
Registry conditions: Cervix Cancer, Screen HPV-positive. Basic parameters: 30 years — 64 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Recruitment and enrollment rate [Time frame: Up to 6 months]
  • Retention rate [Time frame: Up to 6 months]
  • HPV positive screening rate [Time frame: Up to 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07294066 · 25-1747 Aim3 · K23MD020429

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗