Using Mathematical Modelling to Determine the Number and Characteristics of People Living With Undiagnosed HIV to Inform Targeted and Innovative HIV-testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,211
- 试验地点
- 1
- 主要终点
- Number of HIV-diagnoses made by GPs in Flanders
研究概览
简要总结
An innovative HIV-testing strategy is developed based on mathematical modeling results on undiagnosed HIV and being implemented in primary care settings in Belgian's Flemish region.
The systematically developed intervention aims at increasing the number of targeted HIV tests in primary care in order to identify people with undiagnosed HIV.
The intervention tool is an HIV-screening advice targeting general practitioners (GPs), combining indicator-condition based screening and target-group based screening. A group-level training to apply this advice in routine practice is being delivered as part of the continuing medical education through GP-associations.
The intervention is implemented across Flanders adopting a modified stepped wedged design: two different intervention levels (delivering written/online information on the HIV testing advice versus information plus group-level training) are being compared with a control condition (no intervention, i.e. standard practice) based on surveillance data. A mixed-method study evaluates the intervention's effectiveness, feasibility, and acceptability.
详细描述
An innovative HIV-screening strategy is developed based on mathematical modelling on undiagnosed HIV and being implemented in primary care settings in Belgian's Flemish region.
A multidisciplinary advisory board including stakeholders from the public sector, community-based organizations and primary care physicians (general practitionners; GPs) has been set up to advise on the different phases of the intervention's systematic development and implementation.
Mathematical modelling using a back-calculation approach with national HIV-surveillance data delivered estimations of undiagnosed HIV and time-distribution between HIV-acquisition and diagnosis: 2805 (confidence interval: 2478 - 3186) people living with HIV remained undiagnosed in 2015, with highest rates among non-Belgian men having sex with men, and sub-Saharan African (SSA) women followed by SSA men (Marty et al., 2017) . These results informed the intervention objectives: to increase the numbers of HIV-tests performed, of new HIV-diagnoses among the priority groups with undiagnosed HIV, and of timely HIV diagnoses in these groups to link HIV positive individuals to care.
A systematic literature review (Deblonde et al., 2018) indicated that many diagnostic opportunities were missed in primary care. Therefore, formative qualitative research was conducted with 122 purposively selected GPs to understand their perceived barriers and facilitators for HIV-testing. Based on these results, the following intervention determinants are addressed: HIV-knowledge, motivation to test and skills to proactively offer an HIV-test in a non-judgmental manner. Formative research and input from the advisory board also informed the delivery mode of the intervention.
The intervention consists of an HIV-screening advice combining indicator-condition based screening (adapted for primary care) and target-group based screening. A multidisciplinary group-level training (one evening session) to apply this advice in routine practice is being delivered as part of the continuing medical education through GP-associations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Flemish general practitioner associated with a GP-circle (local general practitioner-umbrella organization)
排除标准
- 未提供
研究组 & 干预措施
Level 1: Online dissemination of the HIV screening advice
General practitioners included at the first level receive the HIV-testing advice through a personal electronic mail by their local GP-organization coordinator containing an information message with the printer-friendly screening advice attached. The message also provides a link to the website of the Flemish umbrella organization for GPs (https://domusmedica.be), where the tool is available for download for all Flemish GPs. A reminder is sent out to all participants after 13 months.
干预措施: HIV-screening advice (Behavioral)
Level 2: additional group-level training session
At the second intervention level, GPs first receive intervention condition 1 and additionally the face-to-face group-level training session. These sessions are organized as part of regular 'continuous medical education' provided by the GP organizations ('quality circles') at their usual venues and are organized a few months after receiving intervention level 1. A reminder of the advice is sent out 13 months after the initiation of intervention level 1.
干预措施: HIV-screening advice (Behavioral)
Level 2: additional group-level training session
At the second intervention level, GPs first receive intervention condition 1 and additionally the face-to-face group-level training session. These sessions are organized as part of regular 'continuous medical education' provided by the GP organizations ('quality circles') at their usual venues and are organized a few months after receiving intervention level 1. A reminder of the advice is sent out 13 months after the initiation of intervention level 1.
干预措施: HIV-testing advice plus group-level training (Behavioral)
Control
Standard of care (no specific intervention)
结局指标
主要结局
Number of HIV-diagnoses made by GPs in Flanders
时间窗: Each participant is assessed for 24 months, data is available end 2019
Change in the number of new HIV-diagnosis made by GPs (2016 data serve as baseline, and are compared to 2017 and 2018 data)
次要结局
- Number of HIV-tests prescribed by GPs(Each participant is assessed for 24 months, data is available mid 2020)
- Acceptability of the HIV-testing advice/group-level training in GP's routine practice measured by a self-developed questionnaire and in-depth telephone interviews.(17 months after start intervention)
- HIV diagnoses among groups identified to be more likely undiagnosed(Each participant is assessed for 24 months, data is available end 2019)
- Distribution of new diagnoses by CD4-cell count(Each participant is assessed for 24 months, data is available end 2019)
- Rate of new diagnoses by number of tests(Each participant is assessed for 24 months, data is available mid 2020)
- GP's fidelity to the HIV-testing advice assessed qualitatively by in-depth telephone interviews(17 months after start intervention)
- Feasibility of implementing the HIV-testing advice/group-level training in GP's routine practice measured by a self-developed questionnaire and in-depth telephone interviews.(17 months after start intervention)