Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina Aim 3
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 112
- 主要终点
- Recruitment and enrollment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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:
研究组 & 干预措施
Woman
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.
干预措施: Human papilloma virus screening (Diagnostic Test)
Community partners
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.
结局指标
主要结局
Recruitment and enrollment rate
时间窗: Up to 6 months
Proportion of eligible unscreened women recruited, with a target enrollment of 100 participants from Lenoir County.
Retention rate
时间窗: 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
时间窗: Up to 6 months
Rate of HPV-positive screening rate among woman started study will be reported.
次要结局
未报告次要终点