Expanding Access to Cervical Cancer Screening Through Primary HR-HPV Testing and Self-sampling: a Multicomponent Intervention for Safety Net Health Systems
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7,100
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
研究概览
简要总结
To learn about the attitudes toward implementing self-collection among healthcare providers and staff, participants, and other stakeholders; and to inform the development of patient education and provider training materials to aid in the implementation of self-collection in clinical settings.
详细描述
The overarching goal of the implementation program is to increase cervical cancer screening, early detection, and linkage to treatment in underserved populations that receive care in safety net health systems. Specific goals are:
- To increase up-to-date cervical cancer screening coverage by 10%;
- To increase clinical encounters used for opportunistic cervical cancer screening using primary HR-HPV testing by 5% annually;
- To increase awareness and readiness for implementing primary HR-HPV testing with self-sampling in routine care among clinics in the ECHO Network;
- All patrticipants with abnormal screening results will be navigated to and receive diagnostic testing.
The overarching goal of program evaluation (i.e., research component of this protocol) is to evaluate the progress and achievement of program goals and to evaluate effectiveness and implementation outcomes:
Primary objective 1: Evaluate the effectiveness of primary HPV testing and self-collection to increase participation in cervical cancer screening among underscreened health system participants.
Primary objective 2: Evaluate implementation outcomes of the program across health systems and clinics and explore mechanisms underlying outcomes, guided by the Consolidated Framework for Implementation Research (CFIR)41,42 and RE-AIM (reach, effectiveness, adoption, implementation, maintenance)43.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Populations involved in the research are:
- •stakeholder advisory board members;
- •patients eligible for cervical cancer screening participating in the cluster randomized stepped-wedge trial;
- •patients and community members participating in formative research activities;
- •providers, clinic staff, and other health system stakeholders from partnering health systems;
- •Project ECHO Participants (providers, clinic staff, and other health system stakeholders from partner and non-partner institutions);
- •Other Clinical Networks (providers, clinic staff and other health system stakeholders from partner and non-partner institutions)
- •The eligibility criteria for each are:
- •Patients eligible for cervical cancer screening:
- •Currently a resident in the state of Texas
- •Attend for care at a partner clinic enrolled in the study
- •Women and persons with a cervix
- •Age 25-65
- •Due or past due for cervical cancer screening
- •Patients and community members participating in formative research activities:
- •Purposively identified as a stakeholder for formative research by research staff
- •Providers, clinic staff, and other health system stakeholders from partnering health systems:
- •Employed at least part-time by a partnering health system
- •Project ECHO Participants:
- •Participate in at least one Project ECHO session
- •Other Clinical Networks:
- •Participate in at least one clinical network session
排除标准
- •Patients eligible for cervical cancer screening:
- •Report being currently pregnant
- •History of total hysterectomy
- •History of cervical cancer
- •Other study populations:
- •Unable to communicate in English or Spanish
- •Vulnerable Populations Participants/samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults, or prisoners) will be prohibited from participation.
研究组 & 干预措施
Intervention
Participants participate in an interview or a focus group discussion and provide opinions about self-collection and/or education and training materials for participants and providers.
Partipants participation in this study may be limited to a single interview or focus group discussion. Some stakeholders will be asked to participate in additional interviews and/or focus groups.
干预措施: HR-HPV Testing (Behavioral)
结局指标
主要结局
Safety and Adverse Events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
时间窗: Through study completion; an average of 1 year.
次要结局
未报告次要终点