| Protocol No: | ECCT/25/02/09 | Date of Protocol: | 05-09-2024 |
| Study Title: | Diagnostic Access to Self-Care & Health Services in Low- and Middle-Income Countries (DASH) – Phase II Study |
| Study Objectives: | 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. |
| Laymans Summary: | In many low- and middle-income countries, like Kenya, people are struggling with both infectious diseases such as malaria, HIV, and TB, and chronic conditions like diabetes and high blood pressure. Rapid diagnostic tests (RDTs) are simple tests that can quickly identify these diseases and can be used outside hospitals, including at home or by community health workers.This study focuses on how using RDTs, along with mobile health services and mapping technology, can improve health outcomes, reduce costs, and increase patient satisfaction. New types of RDTs are available, but not many studies have compared different ways of using these tests for quick diagnosis and treatment. The main goal of this research is to test two different strategies using RDTs to see which one helps people get diagnosed and treated faster. By doing this, we hope to show that these tests, combined with mobile health services and support from community health workers, can help more people get the care they need quickly and improve their overall health. The results of this study will help design a larger trial to further test and refine these strategies. |
| Abstract of Study: | Many low- and middle-income countries (LMICs) countries are facing a double burden of acute infections (malaria, HIV, TB) and chronic non-communicable diseases (diabetes, hypertension). Rapid diagnostic tests (RDTs) can be used for a range of health conditions outside clinic-based settings, including self-administered testing at home, community health worker-facilitated testing, or testing facilitated by other health workers. When paired with mobile health services and geospatial mapping, testing with RDTs may further improve health outcomes, reduce health care costs, and enhance patient care satisfaction. Several novel RDTs are available for either screening or diagnostic testing, but few studies have evaluated and compared testing strategies for accelerated diagnosis and treatment for infections. Our primary aim is to conduct a randomized controlled trial to evaluate two on-demand testing strategies using RDTs for accelerated linkage to care and treatment. Overall, we expect to demonstrate that on-demand RDT testing with mobile health service linkage through community health workers can increase case identification, accelerate time to care and treatment initiation, and improve health outcomes in resource-limited regions. Results of this study will inform a proposal for a larger randomized clinical trial |