Adapting and Piloting an Evidence-based Intervention to Improve Hypertension Care among Tanzanians Living with HIV

摘要 在撒哈拉以南非洲（SSA），艾滋病毒感染者（PLWH）面临着一种新的不受控制的流行病， 高血压是全球死亡的主要危险因素。目前的护理模式在SSA是不够的， 尽管目前的干预措施无法解决艾滋病毒携带者高血压日益加重的负担，但针对这一人群的干预措施却很少。我们 以前试点的社区卫生工作者（CHW）提供的高血压管理试点（CHAMP）， 由坦桑尼亚艾滋病诊所内的CHW提供的基于诊所的高血压教育干预， 并发现它是高度可行和可接受的。然而，CHAMP的有效性和可持续性仍然存在， 未经证实与此相反，控制血压和风险衰减（COBRA），一个多组件 干预措施，包括社区卫生工作者提供的教育和血压监测， 协议转诊给医生，证明了改善高血压控制和减少所有- 在亚洲3个国家进行的一项随机分组试验中，基于证据的干预措施，如 COBRA在SSA的PLWH人群中实现高血压控制方面有相当大的希望，但尚未被广泛应用。 在这个人群中研究。 在这项为期2年的研究中，我们将整合一个循证的，多组分的，CHW提供的高血压 干预（COBRA）与我们早期的经验，产生CHAMP，以改善高血压护理和减少 坦桑尼亚艾滋病病毒携带者中的血压。使用实现科学的方法，我们将调整COBRA， 坦桑尼亚艾滋病毒诊所内的交付，检查实施结果，并估计在 为随后在坦桑尼亚进行的大规模混合有效性实施试验做准备。在目标1中， 我们将组建一个由主要利益相关者组成的设计咨询小组，以协助进行干预调整。 COBRA和CHAMP的适应和整合将在ADAPT的指导下迭代进行8个月， ITT模型，并通过我们先前收集的定性数据描述障碍和促进因素， PLWH高血压护理在目标2中，我们将在术前和术后使用单臂进行适应性干预试验 在两个艾滋病毒诊所进行可行性试验，并评估实施情况（覆盖范围、可采用性、实施情况、维持情况） 和初步有效性结果（高血压控制、收缩压和舒张压， 抗高血压依从性、心血管疾病风险评分和高血压知识）。我们的研究 我们的团队由高血压、艾滋病毒和实施科学方面的专家组成，我们与 社区机构和卫生系统使我们非常适合开展这项工作。 拟议的计划将为R 01应用程序评估实施情况奠定基础， 有效性和可扩展性的适应性干预措施在坦桑尼亚的一个完全动力的试验，并帮助干 SSA中PLWH中心血管合并症的上升趋势。

Abstract In sub-Saharan Africa (SSA), people living with HIV (PLWH) face a new epidemic of uncontrolled hypertension, the leading risk factor for death worldwide. Current care models in SSA are inadequate to address the growing burden of hypertension in PLWH, yet few interventions targeting this population exist. We previously piloted Community Health Worker (CHW)-delivered Hypertension Management Pilot (CHAMP), a clinic-based hypertension educational intervention delivered by a CHW situated within a Tanzanian HIV clinic, and found it to be highly feasible and acceptable. However, the efficacy and sustainability of CHAMP remains unproven. In contrast, Control of Blood Pressure and Risk Attenuation (COBRA), a multi-component intervention consisting of community-based CHW-delivered education and blood pressure monitoring and protocolized referrals to physicians, demonstrated efficacy in improving hypertension control and reducing all- cause mortality in a cluster-randomized trial across 3 countries in Asia. Evidence-based interventions like COBRA hold considerable promise in achieving hypertension control among PLWH in SSA, but have not been studied in this population. In this 2-year study, we will integrate an evidence-based, multi-component, CHW-delivered hypertension intervention (COBRA) with our early experience deriving CHAMP to improve hypertension care and reduce blood pressure among PLWH in Tanzania. Using implementation science methods, we will adapt COBRA for delivery within the Tanzanian HIV clinic, examine implementation outcomes, and estimate effect size in preparation for a subsequent large-scale, hybrid effectiveness-implementation trial across Tanzania. In Aim 1, we will assemble a Design Consultation Team of key stakeholders to assist in intervention adaption. Adaptation and integration of COBRA and CHAMP will occur iteratively over 8 months, guided by the ADAPT- ITT model, and informed by our previously collected qualitative data describing barriers and facilitators to hypertension care for PLWH. In Aim 2, we will pilot the adapted intervention with a single arm pre-post feasibility trial in two HIV clinics and assess implementation (reach, adoptability, implementation, maintenance) and preliminary effectiveness outcomes (hypertension control, systolic and diastolic blood pressure, antihypertensive adherence, cardiovascular disease risk score, and hypertension knowledge). Our research team, comprised of experts in hypertension, HIV, and implementation science and our robust relationships with community agencies and health systems make us well-suited to conduct this work. The proposed program will lay the groundwork for an R01 application to evaluate implementation, effectiveness, and scalability of the adapted intervention in a fully powered trial across Tanzania and help stem the rising tide of cardiovascular comorbidities among PLWH in SSA.