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）中，患有艾滋病毒（PLWH）的人面临着不受控制的新流行病 高血压，世界范围内死亡的主要危险因素。 SSA的当前护理模型不足 解决了PLWH中高血压的日益增长的负担，但很少有针对该人群的干预措施。我们 以前是试验的社区卫生工作者（CHW）授予高血压管理飞行员（Champ）， 位于坦桑尼亚艾滋病毒诊所内的CHW提供的基于诊所的高血压教育干预措施， 并发现它是高度可行和可接受的。但是，冠军的功效和可持续性仍然存在 未经证实。相比之下，控制血压和风险衰减（COBRA），多组分 干预措施包括基于社区的CHW提供的教育和血压监测以及 方案转介给医生，证明了改善高血压控制和减少全能的功效 在亚洲3个国家的一项集群随机试验中导致死亡率。基于证据的干预措施 眼镜蛇在SSA中实现PLWH的高血压控制方面有很大的希望，但不是 在这个人群中学习。 在这项为期两年的研究中，我们将整合一个基于证据的多组分，CHW递送的高血压 干预（COBRA）与我们的早期经验衍生出冠军，以改善高血压护理并减少 坦桑尼亚PLWH中的血压。使用实施科学方法，我们将使眼镜蛇适应 在坦桑尼亚艾滋病毒诊所内交付，检查实施结果，并估计效果大小 准备随后在坦桑尼亚进行的大规模，混合有效性试验。在AIM 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，以协助进行干预适应。 眼镜蛇和冠军的适应和整合将在8个月内迭代地进行，在适应的指导下 - ITT模型，并由我们先前收集的定性数据介绍，描述了障碍和促进者 PLWH的高血压护理。在AIM 2中，我们将用单臂前驾驶改编的干预措施 在两个艾滋病毒诊所的可行性试验并评估实施（可采用，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 由高血压，艾滋病毒和实施科学专家组成的团队以及我们与 社区机构和卫生系统使我们非常适合进行这项工作。 拟议的计划将为R01应用程序奠定基础，以评估实施， 在整个坦桑尼亚的全力试验中，适应性干预的有效性和可伸缩性，并有助于STEM SSA中PLWH中心血管合并症的上升潮流。