Apers Hanne, Vuylsteke Bea, Loos Jasna, Smekens Tom, Deblonde Jessika, Van Beckhoven Dominique, Nöstlinger Christiana
Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
Centre for Migration and Intercultural Studies, University of Antwerp, Antwerp, Belgium.
JMIR Res Protoc. 2020 Aug 17;9(8):e16486. doi: 10.2196/16486.
Late diagnosis of HIV fosters HIV transmission and may lead to hidden HIV epidemics. In Belgium, mathematical modeling indicates a high prevalence of undiagnosed HIV infections among men who have sex with men of non-Belgian origin and among sub-Saharan African migrants. Promotion of HIV testing facilitates early diagnosis, but diagnostic opportunities are missed in primary care.
The intervention study aims to enhance provider-initiated HIV testing by GPs. This protocol presents the conceptual development, implementation, and evaluation of an HIV-testing intervention for Flemish general practitioners (GPs).
A mixed methods evaluation design is used. Guided by a simplified intervention mapping approach, an evidence-based intervention was developed in collaboration, guided by an interdisciplinary advisory board. The intervention consisted of an evidence-based tool (ie, "HIV-testing advice for primary care") to support GPs in provider-initiated HIV testing. A modified stepped-wedge design compare two different intervention levels: (1) online dissemination of the HIV-testing advice and (2) dissemination with additional group-level training. Both conditions were compared against a control condition with no intervention. The effect of the intervention was measured using Poisson regression for national surveillance data. The primary outcome was the number of HIV diagnoses made by GPs. Secondary outcomes were HIV diagnoses among groups at risk for undiagnosed HIV, distribution of new diagnoses by CD4 cell count, number of HIV tests prescribed by GPs, and rate of new diagnoses by tests. To evaluate the intervention's implementation, the GPs' fidelity to the intervention and the intervention's feasibility and acceptability by GPs were assessed through (web-based) surveys and in-depth telephone interviews.
The study was funded in 2016 and ethically approved in January 2017. The implementation of the intervention started in January 2017 and ended in December 2018. Data was completed in October 2019 and was the starting point for the ongoing data analysis. The results are expected to be published in the second half of 2020.
Results of the intervention study will provide useful information on the intervention's effectiveness among Flemish GPs and can inform further development of official testing guidelines. Limitations of this real-life intervention approach are potential spill-over effects, delay in access to surveillance data, and little detailed information on HIV-testing practices among GPs.
ClinicalTrials.gov NCT04056156; https://clinicaltrials.gov/ct2/show/NCT04056156.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16486.
HIV的晚期诊断会助长HIV传播，并可能导致潜在的HIV流行。在比利时，数学模型显示，在非比利时裔男男性行为者以及撒哈拉以南非洲移民中，未被诊断出的HIV感染患病率很高。推广HIV检测有助于早期诊断，但初级保健中仍存在诊断机会缺失的情况。
这项干预研究旨在提高全科医生（GP）主动进行HIV检测的比例。本方案介绍了针对弗拉芒地区全科医生的HIV检测干预措施的概念开发、实施和评估。
采用混合方法评估设计。在一个跨学科咨询委员会的指导下，以简化的干预映射方法为指导，合作开发了一项基于证据的干预措施。该干预措施包括一个基于证据的工具（即“初级保健HIV检测建议”），以支持全科医生主动进行HIV检测。采用改良的阶梯楔形设计比较两个不同的干预水平：（1）在线传播HIV检测建议；（2）传播并提供额外的小组培训。将这两种情况与无干预的对照情况进行比较。使用泊松回归分析国家监测数据来衡量干预效果。主要结果是全科医生做出的HIV诊断数量。次要结果包括未被诊断出HIV的高危人群中的HIV诊断情况、按CD4细胞计数划分的新诊断分布、全科医生开出的HIV检测数量以及检测后的新诊断率。为了评估干预措施的实施情况，通过（基于网络的）调查和深入电话访谈，评估全科医生对干预措施的依从性以及干预措施对全科医生的可行性和可接受性。
该研究于2016年获得资助，并于2017年1月获得伦理批准。干预措施的实施于2017年1月开始，2018年12月结束。数据于2019年10月完成，是正在进行的数据分析的起点。预计结果将于2020年下半年公布。
干预研究的结果将为弗拉芒地区全科医生中干预措施的有效性提供有用信息，并可为官方检测指南的进一步制定提供参考。这种现实生活干预方法的局限性包括潜在的溢出效应、获取监测数据的延迟以及关于全科医生HIV检测实践的详细信息较少。
ClinicalTrials.gov NCT04056156；https://clinicaltrials.gov/ct2/show/NCT04056156。
国际注册报告识别码（IRRID）：DERR1-10.2196/16486。
