Evaluation of Antigen Rapid Diagnostic Tests (Ag-RDTs) for Community Identification of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Kiambu County, Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 case detection rate
研究概览
简要总结
Background:
Background: Testing with antigen-detecting rapid diagnostic tests (Ag-RDTs), including in asymptomatic individuals, has the potential to promptly identify more Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections and consequently decrease spread of coronavirus-19 disease at the community level. In addition, rapid test results are important for immediate clinical management and isolation of patients with SARS-CoV-2 infection, and for contact tracing and quarantining of contacts. Data on SARS-CoV-2 infection rates, the acceptability of Ag-RDT, and the cost of conducting widespread testing in these communities are limited in Africa.
Study Aim and Objectives: To generate evidence evaluating the use of Ag-RDTs for community identification of SARS-CoV-2 infections within large gathering venues such as work places, schools, places of worship, and markets.
The primary objective is to determine the SARS-CoV-2 case detection rate through a mass testing approach in large gatherings. Secondary objectives include determining the proportion of asymptomatic and symptomatic infections detected, acceptance of mass SARS-CoV-2 Ag-RDT testing, the prevalence of circulating variants, and the cost of implementing this community testing strategy.
Study Design: The investigators propose a serial cross-sectional study design targeting approximately 15,000 persons, who will be offered testing in up to 50 different high attendance venues of Kiambu County that will be identified as possible points of community-based transmission. The study will follow an opt-in consent approach, with those accepting to participate providing additional information to the trained research assistant and/or health worker.
Outcome: Evidence will be generated to provide recommendations to the Kenya Ministry of Health, and more broadly to inform the field on the use of Ag-RDTs for large scale community screening by identifying best practices and stratifying risk areas for community transmission based on rates of infections detected within various settings.
详细描述
Study context
Since 31 March 2020, when the first case was confirmed in the country, a total of 20144 confirmed cases and 877 deaths (case fatality rate of (4.4%) have been line-listed as of 27th February 2022. Kiambu ranks second in cumulative number of confirmed Coronavirus-19 cases. Kiambu county has major gaps in Coronavirus-19 management due to inadequate resources limiting response capacity in detecting, investigating, contact tracing and follow up both in the facilities and within the community. The county has reported spikes in cases of Coronavirus-19 following participation in mass gathering events like in political rallies, markets, churches, burials, etc. The county has several tertiary institutions which have also been identified as high transmission hotspots. Kiambu county implements the Coronavirus-19 guidelines as stipulated in the ministry of health guidelines (hand washing, social distancing, use of masks etc), but non-compliance with Coronavirus-19 protocols has been noted in learning institutions and public places like Bus parks, markets and supermarkets.
The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) is supporting the Ministry of Health (MOH) in Kenya to accelerate an effective Coronavirus-19 response through novel solutions to increase access to high quality diagnostics and therapeutics through the Unitaid-funded Catalysing Coronavirus-19 Action (CCA) project. As part of this project, EGPAF is supporting decentralizing testing through integration of severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) antigen rapid diagnostic test (Ag RDT) into Maternal Newborn Child Health, Tuberculosis and HIV clinics in about 31 facilities of Kiambu county. The project also enhances linkage to care and treatment including new therapeutics through a hub and spoke model. EGPAF works with civil society organizations and other key stakeholders in Kiambu county to increase demand for SARS-CoV-2 testing and care and treatment. This study will build upon the programmatic components of the CCA project to explore the effectiveness of SARS-CoV-2 AgRDT mass testing in high volume community venues to detect SARS-CoV-2 infections. The CCA project has been implemented since October 2021 with testing using Ag-RDT since January 2022 in Kiambu county. It has been observed that a number of clients attending facilities in services where the test is not currently offered are asking for testing, and during community vaccination campaigns, people are asking for the possibility to be tested.
Study Rationale As of 14 March 2022, 28.8% of adults were fully vaccinated in Kenya 4. Until vaccines have widespread availability, testing and isolation are the best methods to control disease spread at the national level. The use of simple, rapid, and affordable Ag-RDT to expand access to SARS-CoV-2 testing is being incorporated in many national Coronavirus-19 responses. Targeting high volume community venues has the potential to screen a lot of people within a limited amount of time and determine areas that are contributing to community transmission. Data on acceptability of mass SARS-CoV-2 Ag-RDT testing in these community settings in Africa are limited.
Most current programs use a screen and test strategy to identify symptomatic infection and those at risk due to exposure because of the limited availability and costs of broader testing. However, this strategy does not identify those with asymptomatic infection who also contribute to the spread of SARS-CoV-2 infection. Data are needed to inform the evolving SARS-CoV-2 testing guidelines and provide MOH with feasible and costed testing models to address their national strategies. This study will generate the evidence needed to determine the SARS-CoV-2 case detection rate and proportion of asymptomatic and symptomatic infections detected in high volume community venues using SARS-CoV-2 Ag-RDTs. Additionally, full genome sequencing of positive cases will be useful to the MoH in determining the circulating genomic strains in Kenya at real time and may contribute to national guidance.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 2 years
- •Agrees to Undergo testing with SARS-CoV-2-Ag RDT on the day of testing campaign
- •Ability and willingness to provide written consent/assent for participation in an interview following the test
排除标准
- •Positive SARS-CoV-2 test done 1 to 14 days before the current testing campaign
结局指标
主要结局
SARS-CoV-2 case detection rate
时间窗: This will be done in a period of 4 months of study enrolment
Will determine the proportion of SARS-CoV-2 infections detected per 100 individuals tested) in high volume community venues using SARS-CoV-2 Ag-RDT, overall and disaggregated by venue type.
次要结局
- Proportion testing positive across the cascade(4 months)
- SARS-COV-2 variants(4 months)
- Positive cases by type(4months)
- Factors(4 months)
- Costing(4months)
研究者
Rose Otieno Masaba
Associate Director Public Health Evaluations
Elizabeth Glaser Pediatric AIDS Foundation