Harmonizing Implementation and Outcome Data Across HIV Prevention and Care Studies in Resource-Constrained Settings.

Geri R Donenberg, Katherine G Merrill, Chisom Obiezu-Umeh, Ucheoma Nwaozuru, Dara Blachman-Demner, Sujha Subramanian, Amanda Fournier, Juliet Iwelunmor
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Abstract

Harmonizing measures across studies can facilitate comparisons and strengthen the science, but procedures for establishing common data elements are rarely documented. We detail a rigorous, 2-year process to harmonize measures across the Prevention And Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings (PATC3H) consortium, consisting of eight federally-funded studies. We created a repository of measured constructs from each study, classified and selected constructs for harmonization, and identified survey instruments. Measures were harmonized for implementation science, HIV prevention and care, demographics and sexual behavior, mental health and substance use, and economic assessment. Importantly, we present our harmonized implementation science constructs. A common set of implementation science constructs have yet to be recommended in the literature for low-to-middle-income countries despite increasing recognition of their importance to delivering and scaling up effective interventions. Drawing on RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) and the Implementation Outcomes Framework, items were harmonized for staff/administrators and study participants to measure reach, adoption, implementation, maintenance, feasibility, acceptability, appropriateness, and fidelity. The process undertaken to harmonize measures and the codified set of implementation science measures developed by our consortium can inform future data harmonization efforts, critical to strengthening the replication and generalizability of findings while facilitating collaborative research-especially in resource-limited settings. We conclude with recommendations for research consortia, namely ensuring representation from all study teams and research priorities; adopting a flexible, transparent, and systematic approach; strengthening the literature on implementation science harmonization; and being responsive to life events (e.g., COVID-19).

Supplementary information: The online version contains supplementary material available at 10.1007/s43477-022-00042-7.

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在资源有限的环境中,统一各项 HIV 预防和护理研究的实施和结果数据。
统一各项研究的测量方法可以促进比较并加强科学性,但建立通用数据元素的程序却很少被记录下来。我们详细介绍了一个为期 2 年的严格过程,该过程旨在统一由 8 项联邦政府资助的研究组成的 "通过对资源有限环境中受 HIV 影响的青少年进行全面护理来实现预防和治疗"(PATC3H)联盟的测量指标。我们从每项研究中创建了一个测量建构库,对建构进行了分类和选择,以便进行统一,并确定了调查工具。我们对实施科学、艾滋病预防和护理、人口统计学和性行为、心理健康和药物使用以及经济评估的测量方法进行了统一。重要的是,我们提出了统一的实施科学概念。尽管中低收入国家越来越认识到实施科学对提供和推广有效干预措施的重要性,但文献中尚未推荐一套通用的实施科学构建方法。借鉴 RE-AIM(覆盖面、有效性、采纳、实施、维持)和实施成果框架,为工作人员/管理者和研究参与者统一了项目,以衡量覆盖面、采纳、实施、维持、可行性、可接受性、适当性和忠实性。统一测量方法的过程以及我们联合开发的成套实施科学测量方法可以为未来的数据统一工作提供参考,这对加强研究结果的复制和推广至关重要,同时还能促进合作研究,尤其是在资源有限的环境中。最后,我们对研究联盟提出了建议,即确保所有研究团队和研究重点的代表性;采用灵活、透明和系统的方法;加强实施科学协调方面的文献;以及对生命事件(如 COVID-19)做出响应:在线版本包含补充材料,可查阅 10.1007/s43477-022-00042-7。
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