An Individually Randomised Trial of Rapid Diagnostic Tests in Rural Ghana
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7,263
- 试验地点
- 1
- 主要终点
- The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis
研究概览
简要总结
- To compare in a setting where microscopy for malaria is available whether introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v clinical diagnosis).
详细描述
BACKGROUND There is good evidence from multiple sites, including in Ghana, that malaria is massively over-diagnosed. It could be argued that where microscopy is not available it can be introduced, and elsewhere it can be improved, but high-quality microscopy is not easy to sustain. If substantial over-diagnosis continues in Ghana in an era where an ACT is now the first-line treatment, it will lead to the intervention being substantially more expensive due to over-prescription than it should be, potentially rendering it unsustainable.
The introduction of rapid diagnostic tests (RDTs) has the potential to provide a way of more accurately directing ACTs to those that need them and may also encourage clinicians to consider alternative diagnoses in test-negative cases, reducing the risk of missing treatable, and potentially fatal, alternative causes of febrile illness. RDTs to direct ACT use also have the possibility to be cost-effective, but only if clinicians prescribe logically on the basis of test results.
Initial data from Tanzania suggests that providing RDTs in the context of formal healthcare settings may have little impact on clinician behaviour, but the health system in Ghana is very different, and both clinician and patient beliefs about malaria are likely to be different.
Additionally, this has not been properly tested in areas with little or no access to microscopy, nor where ACTs are currently available, which may influence clinician behaviour. Many believe this is the most useful setting for RDTs, and may limit over-prescription of anti-malarials but there are no data to support this belief, nor are there data on the cost-effectiveness of this approach. This trial aims to test the impact of RDT use on clinician behaviour directly by means of a randomised trial.
OBJECTIVES Principal Objective To determine by means of a randomized trial the impact of the introduction of Rapid Diagnostic Tests (RDTs) on the appropriate prescription of anti-malarials in the two public healthcare settings found in Ghana.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinician decision to test for malaria
排除标准
- •Pregnant women
- •Severe malaria requiring referral
- •Patient refuses consent
- •Clinician specifically requests for microscopy
结局指标
主要结局
The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis
时间窗: Two years
次要结局
- Proportion of RDT test-positive patients who were not prescribed an antimalarial in both settings(Two years)
- Proportion of patients receiving additional or alternative treatments to antimalarials following a negative RDT result and which treatments these are.(Two years)
- Proportion of clinic microscopy slide-negative patients who were prescribed an anti-malarial in the setting with microscopy available(Two years)
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine