社区与机构服务在柬埔寨改善丙型肝炎病毒活跃感染筛查中的效果比较：ANRS 12384 CAM-C 集群随机对照试验-混合方法研究方案。

Community Versus Facility-Based Services to Improve the Screening of Active Hepatitis C Virus Infection in Cambodia: The ANRS 12384 CAM-C Cluster Randomized Controlled Trial-Protocol for a Mixed Methods Study.

机构信息

Aix Marseille Université, Institut national de la santé et de la recherche médicale (INSERM), Institut de recherche pour le développementIRD, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM) Aix Marseille Univ,, Aix Marseille Institute of Public Health (ISSPAM), Marseille, France.

University of Health and Sciences, Phnom Penh, Cambodia.

出版信息

JMIR Res Protoc. 2024 Nov 20;13:e63376. doi: 10.2196/63376.

DOI:10.2196/63376

PMID:39566053

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11618004/

Abstract

BACKGROUND

In Cambodia, hepatitis C constitutes a significant public health challenge, particularly among older adults (>45 years) for whom prevalence is estimated to be 5%. To facilitate the elimination of hepatitis C among the general population, enhancing access to screening and treatment is imperative. In this regard, the evaluation of community-based screening programs emerges as a crucial step toward improving health care accessibility.

OBJECTIVE

This study aims to assess the comparative efficacy of a community-based versus a facility-based approach in enhancing the uptake of hepatitis C antibody testing among the general population older than 40 years of age in Cambodia.

METHODS

The CAM-C (Community Versus Facility-Based Services to Improve the Screening of Active Hepatitis C Virus Infection in Cambodia) study uses a cluster-randomized controlled trial design across two Cambodian provinces to compare community-based and facility-based hepatitis testing interventions. Sampling involves a multistage cluster approach, targeting individuals older than 40 years of age due to their higher prevalence and risk of chronic hepatitis complications. This study incorporates a qualitative analysis of acceptability and a cost-effectiveness comparison. Interventions include facility-based testing with subsequent referral and community-based testing with direct in-home assessments. Follow-up for positive cases involves comprehensive management and potential direct-acting antiviral treatment. This study aims to identify a significant increase in testing uptake, requiring the screening of 6000 individuals older than 40 years of age, facilitated by a structured sampling and intervention approach to minimize contamination risks.

RESULTS

The final protocol including the quantitative, qualitative, and cost-effectiveness part of the study was registered and was approved in 2019 by the National Ethical Cambodian for Health Research. Inclusions were completed by mid-2024, with analyses starting in May 2024.

CONCLUSIONS

Using a mixed methods approach that combines a robust methodology (cluster-randomized controlled trial) with a cost-effectiveness analysis and qualitative research, such a study should provide invaluable information to guide the Ministry of Health in its hepatitis C virus screening strategy and move toward elimination.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03992313; https://clinicaltrials.gov/study/NCT03992313.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63376.

摘要

背景

在柬埔寨，丙型肝炎是一个重大的公共卫生挑战，尤其是在年龄较大的成年人（>45 岁）中，其患病率估计为 5%。为了促进普通人群中丙型肝炎的消除，必须增加对筛查和治疗的获取。在这方面，评估基于社区的筛查计划是改善医疗保健可及性的关键步骤。

目的

本研究旨在评估基于社区的方法与基于机构的方法在提高柬埔寨 40 岁以上人群丙型肝炎抗体检测率方面的比较效果。

方法

CAM-C（社区与基于机构的服务以改善柬埔寨丙型肝炎病毒感染的筛查）研究采用两柬埔寨省的集群随机对照试验设计，比较基于社区和基于机构的肝炎检测干预措施。抽样采用多阶段聚类方法，针对年龄大于 40 岁的人群，因为他们的丙型肝炎患病率和慢性肝炎并发症风险更高。本研究还包括可接受性的定性分析和成本效益比较。干预措施包括基于机构的检测，随后进行转诊，以及基于社区的检测，直接进行家庭评估。对阳性病例进行随访包括全面管理和潜在的直接作用抗病毒治疗。本研究旨在确定检测率的显著提高，需要对 6000 名年龄大于 40 岁的人群进行筛查，采用结构化抽样和干预方法来最小化污染风险。