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Abstract：
BACKGROUND: Despite increasing morbidity and mortality from non-communicable diseases (NCD) globally, health systems in low- and middle-income countries (LMICs) have limited capacity to address these chronic conditions, particularly in sub-Saharan Africa (SSA). There is an urgent need, therefore, to respond to NCDs in SSA, beginning by applying lessons learned from the first global response to any chronic disease-HIV-to tackle the leading cardiometabolic killers of people living with HIV (PLHIV). We have developed a feasible and acceptable package of evidence-based interventions and a multi-faceted implementation strategy, known as \"TASKPEN,\" that has been adapted to the Zambian setting to address hypertension, diabetes, and dyslipidemia. The TASKPEN multifaceted implementation strategy focuses on reorganizing service delivery for integrated HIV-NCD care and features task-shifting, practice facilitation, and leveraging HIV platforms for NCD care. We propose a hybrid type II effectiveness-implementation stepped-wedge cluster randomized trial to evaluate the effects of TASKPEN on clinical and implementation outcomes, including dual control of HIV and cardiometabolic NCDs, as well as quality of life, intervention reach, and cost-effectiveness.
METHODS: The trial will be conducted in 12 urban health facilities in Lusaka, Zambia over a 30-month period. Clinical outcomes will be assessed via surveys with PLHIV accessing routine HIV services, and a prospective cohort of PLHIV with cardiometabolic comorbidities nested within the larger trial. We will also collect data using mixed methods, including in-depth interviews, questionnaires, focus group discussions, and structured observations, and estimate cost-effectiveness through time-and-motion studies and other costing methods, to understand implementation outcomes according to Proctor\'s Outcomes for Implementation Research, the Consolidated Framework for Implementation Research, and selected dimensions of RE-AIM.
CONCLUSIONS: Findings from this study will be used to make discrete, actionable, and context-specific recommendations in Zambia and the region for integrating cardiometabolic NCD care into national HIV treatment programs. While the TASKPEN study focuses on cardiometabolic NCDs in PLHIV, the multifaceted implementation strategy studied will be relevant to other NCDs and to people without HIV. It is expected that the trial will generate new insights that enable delivery of high-quality integrated HIV-NCD care, which may improve cardiovascular morbidity and viral suppression for PLHIV in SSA. This study was registered at ClinicalTrials.gov (NCT05950919).
METHODS: The trial will be conducted in 12 urban health facilities in Lusaka, Zambia over a 30-month period. Clinical outcomes will be assessed via surveys with PLHIV accessing routine HIV services, and a prospective cohort of PLHIV with cardiometabolic comorbidities nested within the larger trial. We will also collect data using mixed methods, including in-depth interviews, questionnaires, focus group discussions, and structured observations, and estimate cost-effectiveness through time-and-motion studies and other costing methods, to understand implementation outcomes according to Proctor\'s Outcomes for Implementation Research, the Consolidated Framework for Implementation Research, and selected dimensions of RE-AIM.
CONCLUSIONS: Findings from this study will be used to make discrete, actionable, and context-specific recommendations in Zambia and the region for integrating cardiometabolic NCD care into national HIV treatment programs. While the TASKPEN study focuses on cardiometabolic NCDs in PLHIV, the multifaceted implementation strategy studied will be relevant to other NCDs and to people without HIV. It is expected that the trial will generate new insights that enable delivery of high-quality integrated HIV-NCD care, which may improve cardiovascular morbidity and viral suppression for PLHIV in SSA. This study was registered at ClinicalTrials.gov (NCT05950919).
摘要：
背景：尽管全球非传染性疾病（NCD）的发病率和死亡率不断上升，低收入和中等收入国家(LMICs)的卫生系统应对这些慢性病的能力有限，特别是在撒哈拉以南非洲（SSA）。迫切需要,因此,为了应对SSA的非传染性疾病，首先，应用从第一个全球应对任何慢性疾病——艾滋病毒——中吸取的经验教训，来应对艾滋病毒感染者（PLHIV）的主要心脏代谢杀手。我们制定了一套可行和可接受的循证干预措施和多方面的实施战略,被称为“任务”，“这已经适应了赞比亚解决高血压的环境，糖尿病,和血脂异常。TASKPEN多方面实施战略的重点是重组艾滋病毒-非传染性疾病综合护理的服务交付，并以任务转移为特征，实践促进，并利用艾滋病毒平台进行非传染性疾病护理。我们提出了一个混合II型有效性-实施阶梯楔形整群随机试验，以评估TASKPEN对临床和实施结果的影响。包括对艾滋病毒和心脏代谢非传染性疾病的双重控制，以及生活质量，干预范围，和成本效益。
方法：该试验将在卢萨卡的12个城市卫生机构中进行，赞比亚为期30个月。临床结果将通过PLHIV获得常规HIV服务的调查进行评估，以及在更大的试验中嵌套的PLHIV与心脏代谢合并症的前瞻性队列。我们还将使用混合方法收集数据，包括深度访谈,问卷，焦点小组讨论,和结构化的观察，并通过时间和运动研究和其他成本计算方法估计成本效益，根据Proctor的实施研究结果来了解实施结果，实施研究综合框架，和RE-AIM的选定尺寸。
结论：本研究的结果将用于离散，可操作,以及赞比亚和该地区针对特定环境的建议，将心脏代谢非传染性疾病护理纳入国家艾滋病毒治疗计划。虽然TASKPEN研究侧重于PLHIV中的心脏代谢非传染性疾病，所研究的多层面实施战略将与其他非传染性疾病和无艾滋病毒者相关。预计该试验将产生新的见解，能够提供高质量的HIV-NCD综合护理，这可能会改善SSA中PLHIV的心血管发病率和病毒抑制作用。本研究在ClinicalTrials.gov（NCT05950919）注册。
方法：该试验将在卢萨卡的12个城市卫生机构中进行，赞比亚为期30个月。临床结果将通过PLHIV获得常规HIV服务的调查进行评估，以及在更大的试验中嵌套的PLHIV与心脏代谢合并症的前瞻性队列。我们还将使用混合方法收集数据，包括深度访谈,问卷，焦点小组讨论,和结构化的观察，并通过时间和运动研究和其他成本计算方法估计成本效益，根据Proctor的实施研究结果来了解实施结果，实施研究综合框架，和RE-AIM的选定尺寸。
结论：本研究的结果将用于离散，可操作,以及赞比亚和该地区针对特定环境的建议，将心脏代谢非传染性疾病护理纳入国家艾滋病毒治疗计划。虽然TASKPEN研究侧重于PLHIV中的心脏代谢非传染性疾病，所研究的多层面实施战略将与其他非传染性疾病和无艾滋病毒者相关。预计该试验将产生新的见解，能够提供高质量的HIV-NCD综合护理，这可能会改善SSA中PLHIV的心血管发病率和病毒抑制作用。本研究在ClinicalTrials.gov（NCT05950919）注册。
