Longenecker Chris T, Kiggundu John Baptist, Ayebare Florence, Muddu Martin, Kayima James, Mutungi Gerald, Ssinabulya Isaac, Schwartz Jeremy I, Spiegelman Donna, Tong Guangyu, Nugent Rachel, Aifah Angela, Kagoya Faith, Cameron Drew B, Hutchinson Brian, Kamya Moses R, Katahoire Anne R, Semitala Fred C
University of Washington School of Medicine, Seattle, WA, USA.
Department of Global Health, University of Washington, 1159 Pacific Ave NE, Seattle, WA, 98195, USA.
BMC Health Serv Res. 2025 Aug 11;25(1):1060. doi: 10.1186/s12913-025-13281-9.
Hypertension (HTN) is the leading cause of cardiovascular morbidity and mortality among people living with HIV (PLWH) in Africa, yet integration of hypertension treatment in HIV clinics is sub-optimal. Cost-effective strategies to implement evidence-based hypertension care for this population are urgently needed to preserve the life-expectancy gains of antiretroviral therapy.
Building on insights gained from a comprehensive mixed-methods formative assessment, we used a human-centered design approach to develop a multi-component HIV-HTN integration (HTN-PLUS) strategy. In a stepped-wedge cluster randomized trial, we are assessing the effectiveness, costs, and implementation of HTN-PLUS as well as a less resource intensive strategy of providing HTN medication and blood pressure cuffs (HTN-BASIC) free of charge to clinics. The trial is being conducted in 16 public and private not-for-profit HIV clinics in Kampala and Wakiso districts in Uganda. The co-primary effectiveness outcomes are population BP control (screened and documented BP < 140/90 mmHg) and HTN patient BP control [BP < 140/90 mmHg among PLWH with HTN]. The trial is designed to have > 80% power to detect a 12%-point increase in both outcomes compared to the pre-implementation control period across a range of scenarios of baseline hypertension prevalence and temporal improvements in the control period. At two pre-specified time points, we are conducting a Learn-As-You-Go optimization analysis and will adapt the HTN-PLUS strategy accordingly. To assess implementation outcomes, we have enrolled a prospective longitudinal mixed-methods cohort study of clinic health workers and PLWH with HTN. An extensive economic evaluation will include time and motion studies, facility-based costing, and out-of-pocket cost surveys to determine costs and cost-effectiveness from a societal perspective.
Innovative implementation strategies to integrate evidence-based hypertension care for PLWH in Africa must be informed by the health workers and PLWH who are cared for across diverse HIV clinics. These clinics currently provide high quality HIV care as evidenced by high rates of HIV viral suppression but often lack the knowledge, skills and resources to provide HTN care. Funders and policymakers critically need to know both the effectiveness and costs to scale these strategies and potentially expand them to include other non-AIDS comorbidities.
ClinicalTrials.gov NCT05609513. Registered on November 11, 2022.
高血压（HTN）是非洲艾滋病病毒感染者（PLWH）心血管疾病发病和死亡的主要原因，但在艾滋病诊所中高血压治疗的整合情况并不理想。迫切需要具有成本效益的策略来为这一人群实施循证高血压护理，以维持抗逆转录病毒疗法所带来的预期寿命增长。
基于从全面的混合方法形成性评估中获得的见解，我们采用以人为主的设计方法来制定一个多组分的艾滋病 - 高血压整合（HTN - PLUS）策略。在一项阶梯式楔形整群随机试验中，我们正在评估HTN - PLUS以及一种资源投入较少的策略（即向诊所免费提供高血压药物和血压计袖带，HTN - BASIC）的有效性、成本和实施情况。该试验正在乌干达坎帕拉和瓦基索区的16家公立和私立非营利性艾滋病诊所进行。共同主要有效性结局是人群血压控制（筛查并记录血压<140/90 mmHg）和高血压患者血压控制[艾滋病病毒感染者中的高血压患者血压<140/90 mmHg]。该试验设计具有超过80%的检验效能，以检测在一系列基线高血压患病率和对照期内时间性改善的情况下，与实施前对照期相比，两个结局均有12个百分点的增加。在两个预先指定的时间点，我们正在进行边做边学的优化分析，并将相应地调整HTN - PLUS策略。为了评估实施结局，我们招募了一项针对诊所医护人员和患有高血压的艾滋病病毒感染者的前瞻性纵向混合方法队列研究。一项广泛的经济评估将包括时间和动作研究、基于机构的成本核算以及自付费用调查，以从社会角度确定成本和成本效益。
为非洲的艾滋病病毒感染者整合循证高血压护理的创新实施策略必须参考不同艾滋病诊所中接受护理的医护人员和艾滋病病毒感染者的意见。这些诊所目前提供高质量的艾滋病护理，艾滋病病毒抑制率很高就是证明，但往往缺乏提供高血压护理的知识、技能和资源。资助者和政策制定者迫切需要了解扩大这些策略的有效性和成本，并有可能将其扩展到包括其他非艾滋病合并症。
ClinicalTrials.gov NCT05609513。于2022年11月11日注册。
