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

调整和试点循证干预措施以改善坦桑尼亚艾滋病毒感染者的高血压护理

• 批准号: 10750666
• 负责人: Julian T Hertz
• 金额: $ 23.17万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-10 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10750666
• 关键词: Address; Adherence; Adopted; Adoption; Adult; Africa South of the Sahara; Anti-Retroviral Agents; Antihypertensive Agents; Area; Asia; Blood Pressure; Blood Pressure Monitors; Body mass index; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Chronic Disease; Clinic; Clinical; Cluster randomized trial; Communities; Community Health; Community Health Aides; Consultations; Counseling; Country; Data; Diastolic blood pressure; Disease; Disease Management; Education; Educational Intervention; Effectiveness; Elements; Enrollment; Evidence based intervention; Face; HIV; Happiness; Health system; Healthcare Systems; Hybrids; Hypertension; Intervention; Investments; Knowledge; Maintenance; Methods; Modeling; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Physicians; Population; Positioning Attribute; Preparation; Primary Health Care; Process; Public Health; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research; Research Priority; Risk; Risk Factors; Southeastern Asia; Strategic Planning; Tanzania; Target Populations; Training; United States National Institutes of Health; Work; acceptability and feasibility; arm; attenuation; blood pressure control; blood pressure reduction; cardiovascular disorder risk; care systems; clinical infrastructure; cohort; comorbidity; design; early experience; effective intervention; effectiveness outcome; effectiveness/implementation trial; evidence base; feasibility trial; hypertension control; hypertensive; implementation evaluation; implementation outcomes; implementation science; implementation/effectiveness; improved; learning community; member; mortality; multi-component intervention; new epidemic; optimism; programs; stem; treatment center; waist circumference

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.

抽象的 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。 SSA 目前的护理模式不足以 解决艾滋病毒感染者日益增加的高血压负担，但针对这一人群的干预措施却很少。我们 先前试点的是社区卫生工作者 (CHW) 提供的高血压管理试点 (CHAMP)， 由坦桑尼亚艾滋病毒诊所内的社区卫生工作者提供基于诊所的高血压教育干预， 并认为这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。相比之下，控制血压和风险减弱（COBRA）是一种多成分的方法 干预措施包括社区卫生工作者提供的教育和血压监测以及 协议转诊给医生，证明在改善高血压控制和减少所有 在亚洲 3 个国家进行的整群随机试验中导致死亡。基于证据的干预措施，例如 COBRA 在实现 SSA PLWH 高血压控制方面前景广阔，但尚未得到落实 在这个人群中进行了研究。 在这项为期 2 年的研究中，我们将整合基于证据的、多成分的、CHW 产生的高血压 干预 (COBRA) 与我们早期获得 CHAMP 的经验相结合，以改善高血压护理并减少 坦桑尼亚 PLWH 的血压。使用实施科学方法，我们将采用 COBRA 在坦桑尼亚艾滋病毒诊所内进行交付，检查实施结果并估计效果大小 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团队，以协助干预措施的调整。 COBRA 和 CHAMP 的适应和集成将在 ADAPT- 的指导下在 8 个月内迭代进行 ITT 模型，并根据我们之前收集的描述障碍和促进因素的定性数据提供信息 PLWH 的高血压护理。在目标 2 中，我们将通过单臂预置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（范围、采用性、实施、维护） 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 团队由高血压、艾滋病毒和实施科学领域的专家组成，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 R01 申请评估实施奠定基础， 在坦桑尼亚进行的全动力试验中，调整干预措施的有效性和可扩展性，并帮助阻止 SSA 的 PLWH 中心血管合并症的发病率呈上升趋势。