Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries (DASH) - Phase II
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,250
- 试验地点
- 3
- 主要终点
- Number of participants who self-report testing for Malaria and HIV
研究概览
简要总结
Our primary goal is to determine if on-demand, home-based rapid testing, or rapid testing done by a community health worker (CHW) results in people testing for diseases more frequently and getting care more quickly. These two testing approaches will be compared to how individuals would normally test if they were concerned about certain diseases.
The main questions the study aims to answer are:
- Do either of the testing approaches result in more people testing themselves for certain diseases when needed?
- Does self-testing at home or testing done by a community health worker increase the number of individuals receiving test results and getting care/treatment more quickly?
- Does at-home screening for high blood pressure and diabetes result in lower blood pressure and hemoglobin A1c levels (an indicator for diabetes)?
详细描述
Our long-term objective is to evaluate the best use case scenarios and implementation of community-based rapid testing to enhance testing adoption and case detection, accelerate linkage to care and treatment, and improve overall health outcomes. In this study, our primary objective is to determine if on-demand, home-based rapid diagnostic testing or community health worker (CHW)-facilitated rapid diagnostic testing may improve testing adoption and access to care for select infectious diseases and non-communicable diseases in Kenya, Zambia, and South Africa. This will be completed by conducting a randomized controlled trial to evaluate two testing strategies using RDTs, as compared to the standard of care.
The specific aims of this study are the following:
- Aim #1 (Primary) - To evaluate whether on-demand, home-based rapid diagnostic testing or community health worker (CHW)-facilitated rapid diagnostic testing improve testing adoption per event (or indication) for malaria or HIV in Kenya, Zambia, and South Africa.
- Aim #2 - To evaluate whether on-demand, home-based rapid testing or community health worker (CHW)-facilitated rapid testing improves the percentage of people or households receiving a test result, improving access to care, or accelerating time to diagnosis/treatment for malaria or HIV in Kenya, Zambia, and South Africa.
- Aim #3 - To evaluate whether household screening for hypertension and diabetes with appropriate referral for confirmatory testing and treatment may decrease the median blood pressure (hypertension) or hemoglobin A1c level (diabetes) during a 6-month observational period in Kenya, Zambia, and South Africa.
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
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resides in the household and has spent ≥1 night at the house in the prior four weeks
- •Plans to reside in the house for duration of the study
- •Willing and able to provide informed consent, assent, or parental consent (where needed)
排除标准
- 未提供
结局指标
主要结局
Number of participants who self-report testing for Malaria and HIV
时间窗: Over a period of 6 months.
* Malaria: Participant self-report of testing for malaria (measured as ever tested between baseline and exit). * HIV: Participant self-report of testing for HIV (measured as ever tested after baseline). * Composite: Participant self-report of testing for malaria or HIV (measured as ever tested after baseline).
次要结局
- Number of participants who self-report testing for Malaria and HIV when indicated(Over a period of 6 months.)
- Time from testing to treatment initiation or linkage to care among participants who tested positive for malaria or HIV(Over a period of 6 months)
- Diagnostic accuracy of a research use only malaria test for asymptomatic or symptomatic infection, as compared to rt-PCR testing from dried blood spots(Over a period of 6 months.)
- Prevalence and incidence of positive malaria test results among participants asymptomatic and symptomatic for malaria among study populations in Zambia and Kenya(Over a period of 6 months.)
研究者
Paul Drain
Professor, Global Health
University of Washington