Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention for Under-served Hispanics
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
研究概览
简要总结
The proposed study will develop and test an implementation strategy called Salud en Mis Manos-Dissemination and Implementation Assistance (SEMM-DIA) which is an internet-accessible cross-platform that includes additional implementation support strategies to increase the reach, effectiveness, and implementation of an evidence-based breast and cervical cancer screening and HPV vaccination program for Latinas (SEMM).
详细描述
This study tests a multicomponent and multifaceted implementation strategy, SEMM-DIA and serves as a model for developing other implementation strategies designed to build the capacity of clinic leadership, intervention champions, and LHWs to plan, manage, and deliver SEMM. Investigators will examine the effect of SEMM-DIA program implementation in a randomized group trial comparing the impact of SEMM-DIA vs. SEMM- Usual Implementation Practice on the reach, effectiveness, implementation, and cost-effectiveness of SEMM in safety-net clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Organization inclusion criteria:
- •Clinic or community health center (CHC) with LHWs serving Latina populations.
- •Expressed intent to participate in the implementation of SEMM.
- •Serve low-income populations with low or no-cost screening and vaccination.
- •Provide comprehensive primary health care services.
- •SEMM Participant Inclusion criteria:
- •Latinas who self-identify as Hispanic/Latina.
- •Latinas who have at least one unmet breast or cervical cancer prevention need, following Electronic Clinical Quality Measures.
- •(1) Latinas aged 21-64 years who have not had a Pap test in the past 3 years, and (2) Latinas aged 30-64 who have not had a HPV test in the past 5 years (CMS eCQM ID: CMS124v9).
- •(3) Latinas aged 51-74 years who have not had a mammogram in the past 2 years (CMS eCQM ID: CMS125v9).
- •(4) Latinas aged 18-26 years who have not initiated HPV vaccination.
- •Note: Some women will have more than one unmet need (e.g., HPV vaccination and pap test), so they will be included in more than one non-adherent group.
排除标准
- •Organization exclusion criteria:
- •Clinics/Community Health Centers not located in Texas.
- •SEMM Participant Exclusion criteria:
- •Latinas with a prior or current cancer diagnosis due to modified cancer screening surveillance guidelines for cancer survivors.
结局指标
主要结局
Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
时间窗: 8-month follow-up
Investigators will assess mammogram completion outcomes using EHR data collection. All participants identified as eligible for a mammogram between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (1)
时间窗: 8-month follow-up
Investigators will assess the level of implementation from baseline to 8-month follow-up using manager assessments.
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).
时间窗: 8-month follow up
Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record time spent in education sessions.
Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).
时间窗: 8-month follow up
Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record # of navigation calls needed to overcome barriers to complete needed services (mammogram, Pap/HPV test, and HPV vaccination).
Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.
时间窗: 8-month follow-up
Investigators will assess implementation fidelity using end-of-study in-depth interviews with LHWs to understand their level of fidelity associated with implementing the program.
Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
时间窗: 8-month follow-up
Investigators will assess HPV vaccination initiation or completion outcomes using EHR data collection. All participants identified as eligible for an HPV vaccination between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (3)
时间窗: 8-month follow-up
Investigators will assess the level of implementation from baseline to 8-month follow-up using in-depth end-of-study interviews with LHWs.
Reach is measured by the proportion of women who participate in SEMM education sessions among those that are eligible in the clinic (among all eligible patients) & in the community (the number of participants that receive SEMM education).
时间窗: 8-month follow up
Reach will assess several factors: Among eligible women, what number participate in SEMM education sessions?
Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
时间窗: 8-month follow-up
Investigators will assess Pap completion outcomes using EHR data collection. All participants identified as eligible for a Pap or HPV screening test between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (2)
时间窗: 8-month follow-up
Investigators will assess the level of implementation from baseline to 8-month follow-up using LHW assessments.
The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (4)
时间窗: 8-month follow-up
Investigators will assess the level of implementation from baseline to 8-month follow-up using in-depth end-of-study interviews with managers.
次要结局
- Cost effectiveness of SEMM-DIA in community and clinic practice settings(8-month follow up)
研究者
Lara Savas
Associate Professor
The University of Texas Health Science Center, Houston