Johnson Karen, Gilbert Louisa, Hunt Timothy, Wu Elwin, Metsch Lisa, Goddard-Eckrich Dawn, Richards Stanley, Tibbetts Rick, Rowe Jessica C, Wainberg Milton L, El-Bassel Nabila
University of Alabama School of Social Work, Little Hall, 670 Bonner Drive, Tuscaloosa, AL 35401, USA.
Columbia University School of Social Work, Social Intervention Group, 1255 Amsterdam Avenue, New York, NY, 10027, USA.
Trials. 2018 Sep 10;19(1):486. doi: 10.1186/s13063-018-2792-3.
This paper describes the study protocol of a hybrid type I randomized controlled trial that evaluates the effectiveness and cost-effectiveness of implementing Empowering African-American Women on the Road to Health (E-WORTH), an Afrocentric, group-based, computerized human immunodeficiency virus (HIV)/sexually transmitted infection (STI) prevention intervention for controlled substance-using black women in community corrections settings in New York City.
METHODS/DESIGN: We provide an overview of E-WORTH's hybrid type I design, which is guided by the Consolidated Framework for Implementation Research (CFIR). E-WORTH combines HIV/STI and intimate partner violence (IPV) prevention components and tests the comparative effectiveness of E-WORTH and streamlined HIV testing versus streamlined HIV testing alone in decreasing biologically confirmed HIV and STI incidence, sexual risk, and IPV, as well as in improving access to HIV and STI prevention services and care.
This paper provides an overview of E-WORTH's intervention protocol and serves as a framework for using hybrid type I designs, guided by the CFIR conceptual framework, to evaluate HIV/STI and IPV prevention interventions in community corrections settings. We discuss how E-WORTH's hybrid type I design advances implementation science through its effectiveness and cost-effectiveness aims as well as through a mixed-methods study that evaluates multilevel theory-driven factors (structural, organizational, staffing, and client) guided by the CFIR that influences the implementation of E-WORTH in a criminal justice setting. This study also addresses the novel challenges and opportunities of implementing an intervention that targets specific racial subgroup(s) in a community corrections setting that services all populations, implementing a group-based intervention with technological components in such settings, and employing community-based participatory research strategies to guide recruitment and retention efforts.
ClinicalTrials.gov, NCT02391233 . Registered on 17 March 2015.
本文描述了一项混合型 I 类随机对照试验的研究方案，该试验评估了实施“助力非裔美国女性走向健康之路”（E-WORTH）项目的有效性和成本效益。E-WORTH 是一种以非洲中心主义为导向、基于小组的计算机化预防干预措施，旨在预防纽约市社区矫正环境中使用管制药物的黑人女性感染人类免疫缺陷病毒（HIV）/性传播感染（STI）。
方法/设计：我们概述了 E-WORTH 的混合型 I 类设计，该设计以实施研究综合框架（CFIR）为指导。E-WORTH 结合了 HIV/STI 和亲密伴侣暴力（IPV）预防组件，并测试了 E-WORTH 与简化 HIV 检测相结合相对于单独进行简化 HIV 检测在降低经生物学确认的 HIV 和 STI 发病率、性风险以及 IPV 方面的比较有效性，同时还测试了在改善获得 HIV 和 STI 预防服务及护理方面的效果。
本文概述了 E-WORTH 的干预方案，并作为一个框架，用于在 CFIR 概念框架的指导下，使用混合型 I 类设计来评估社区矫正环境中的 HIV/STI 和 IPV 预防干预措施。我们讨论了 E-WORTH 的混合型 I 类设计如何通过其有效性和成本效益目标，以及通过一项混合方法研究来推进实施科学。该混合方法研究评估了由 CFIR 指导的多层次理论驱动因素（结构、组织、人员配备和服务对象），这些因素影响了 E-WORTH 在刑事司法环境中的实施。本研究还探讨了在为所有人群服务的社区矫正环境中针对特定种族亚群体实施干预、在这种环境中实施带有技术组件的基于小组的干预以及采用基于社区的参与性研究策略来指导招募和留存工作所面临的新挑战和机遇。
ClinicalTrials.gov，NCT02391233。于 2015 年 3 月 17 日注册。
