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塞内加尔农村地区慢性乙型肝炎感染的负担和影响:在尼奥阿克地区(AmBASS ANRS 12356)进行横断面调查的研究方案。

Burden and impacts of chronic hepatitis B infection in rural Senegal: study protocol of a cross-sectional survey in the area of Niakhar (AmBASS ANRS 12356).

机构信息

Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France.

ORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur, Marseille, France.

出版信息

BMJ Open. 2019 Jul 17;9(7):e030211. doi: 10.1136/bmjopen-2019-030211.

DOI:10.1136/bmjopen-2019-030211
PMID:31320358
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6661601/
Abstract

INTRODUCTION

Though Senegal has one of the highest estimated prevalence rates of chronic hepatitis B virus (HBV) infection worldwide, epidemiological data in the general population are lacking and consequences of the infection remain undocumented. The ANRS-12356 AmBASS study aims at evaluating the health and socioeconomic burden of chronic HBV infection at the individual, household and population level. Its specific objectives are (1) to document the epidemiology of chronic HBV infection, including prevalence and risk factors; (2) to assess the acceptability of home-based testing and first clinic visit; (3) to investigate the repercussions of chronic HBV infection on living conditions; and (4) to estimate the public health impact of chronic HBV infection at the population level and the feasibility of a decentralised model of HBV test and treat.

METHODS AND ANALYSIS

This multidisciplinary cross-sectional survey includes a twofold data collection: (1) home-based screening using dried blood spot (DBS) sampling and collection of sociodemographic, economic and behavioural data, and (2) additional clinical and biological data collection in chronic HBV carriers at the first clinic visit. The prevalence of chronic HBV infection will be estimated in the general population and in key subgroups. Risk factors for HBV acquisition in children will be explored using case-control analysis. HBV burden will be assessed through comparisons of health and economic outcomes between households affected by the disease versus non-affected households. Last, an economic evaluation will assess costs and health benefits of scaling-up HBV care.

ETHICS AND DISSEMINATION

This study was approved by the Senegalese National Ethical Committee for Research in Health, and received authorisation from the Senegalese Ministry of Health and the French Commission on Information Technology and Liberties (Senegalese Protocol Number: SEN17/15). The study results will be presented in peer-review journals, international conferences and at a workshop with national stakeholders in order to contribute to the design of programmes to address the HBV pandemic.

TRIAL REGISTRATION NUMBER

NCT03215732; Pre-results.

摘要

简介

尽管塞内加尔是全球估计慢性乙型肝炎病毒(HBV)感染率最高的国家之一,但目前缺乏一般人群的流行病学数据,且该感染的后果仍未被记录。ANRS-12356 AmBASS 研究旨在评估个体、家庭和人群层面慢性 HBV 感染的健康和社会经济负担。其具体目标是:(1)记录慢性 HBV 感染的流行病学,包括流行率和危险因素;(2)评估家庭检测和首次就诊的可接受性;(3)研究慢性 HBV 感染对生活条件的影响;(4)估计人群层面慢性 HBV 感染的公共卫生影响,以及 HBV 检测和治疗去中心化模式的可行性。

方法和分析

这一多学科的横断面研究包括两部分数据收集:(1)采用干血斑(DBS)采样进行家庭筛查,并收集社会人口统计学、经济和行为数据;(2)在慢性 HBV 携带者的首次就诊时进行额外的临床和生物学数据收集。将在一般人群和关键亚组中估计慢性 HBV 感染的流行率。将使用病例对照分析探讨儿童获得 HBV 的危险因素。将通过比较受疾病影响的家庭和未受影响的家庭的健康和经济结果来评估 HBV 负担。最后,经济评估将评估扩大 HBV 护理的成本和健康效益。

伦理和传播

这项研究得到了塞内加尔国家卫生研究伦理委员会的批准,并获得了塞内加尔卫生部和法国信息技术和自由委员会的授权(塞内加尔方案编号:SEN17/15)。研究结果将在同行评议期刊、国际会议以及与国家利益相关者的研讨会上公布,以便为制定应对 HBV 大流行的方案做出贡献。

试验注册编号

NCT03215732;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e9/6661601/1d716ad63c47/bmjopen-2019-030211f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e9/6661601/1d716ad63c47/bmjopen-2019-030211f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e9/6661601/1d716ad63c47/bmjopen-2019-030211f01.jpg

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