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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Woman participants

Критерии включения

• 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

Критерии исключения

• 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

Критерии включения

• community health workers
• clinic staff
• community-based organization staff.

Критерии исключения

• None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07294066 · 25-1747 Aim3 · K23MD020429

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗