Public Health Institute, Liverpool John Moores University, Liverpool, UK
MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Wakiso, Uganda.
BMJ Open. 2024 Mar 20;14(3):e078044. doi: 10.1136/bmjopen-2023-078044.
INTRODUCTION: Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease. METHODS AND ANALYSIS: This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner's ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension. ETHICS AND DISSEMINATION: The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications. TRIAL REGISTRATION NUMBER: ISRCTN15319595.
简介:撒哈拉以南非洲地区仍面临着艾滋病毒和非传染性疾病(NCD)的双重流行。该地区的垂直(独立)艾滋病毒规划提供了高质量的护理,近 80%的艾滋病毒感染者接受常规护理,90%的病毒得到抑制。虽然在诊所中正在扩大艾滋病毒、高血压和糖尿病的综合健康教育和同时管理,但需要创新、更有效和具有成本效益的干预措施,将权力下放至社区,以应对艾滋病毒/非传染性疾病合并症负担的增加。
方法和分析:本方案描述了在坦桑尼亚和乌干达同时进行的一项实用集群随机试验(INTE-COMM)的过程评估程序,该试验将比较基于社区的综合护理(艾滋病毒、糖尿病和高血压)与标准的基于机构的综合护理。INTE-COMM 干预措施将通过社区护士和经过培训的非专业人员提供的健康监测和药物使用/生活方式建议(药物、饮食和运动),以及将 NCD 药物配给到社区一级,来管理社区中的多种疾病(艾滋病毒、高血压和糖尿病)。基于 Bronfenbrenner 的生态系统理论,该过程评估将使用定性方法,在最多 10 个标准护理机构和/或具有关联医疗设施的干预社区站点中,调查塑造护理提供和结果的社会结构因素。多利益攸关方访谈(患者、社区卫生工作者和志愿者、医疗保健提供者、政策制定者、临床研究人员以及国际和非政府组织)、焦点小组讨论(社区领导人和成员)和非参与性观察(社区会议和药物配给)将从试验实施的三个时间点,从多个角度探索实施情况。迭代抽样和分析,在数据收集点和数据分析之间移动,以测试新兴理论,将持续到达到饱和。这种跨方法和来源的分析反思和三角剖分的过程,将为解释主要试验结果提供依据,并为维持和扩大艾滋病毒、糖尿病和高血压的社区综合护理提供明确的方向。
伦理和传播:该方案已获得伦敦大学学院(英国)、伦敦卫生与热带医学学院伦理委员会(英国)、乌干达国家科学技术委员会和乌干达病毒研究所研究和伦理委员会(乌干达)以及国家医学研究所医学研究协调委员会(坦桑尼亚)的批准。伦敦大学学院是该试验的赞助商。研究结果将通过期刊出版物和利益攸关方会议(与研究参与者、医疗保健提供者、政策制定者和其他利益攸关方)、地方和国际会议、政策简报、同行评议期刊文章和出版物进行传播。
试验注册编号:ISRCTN85656302.
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