NCT06588790

Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries (DASH) - Phase II

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,250 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

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)?

Detailed description

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.

Conditions

• Malaria Infection
• Pregnancy
• HIV
• Diabetes
• Hypertension

Interventions

Type	Name	Description
OTHER	Home-based rapid testing	Participants will be provided with rapid diagnostic tests for HIV, pregnancy and malaria (in Kenya and Zambia only) for on-demand, at-home self testing if/when indicated.
OTHER	Community health worker rapid testing	Participants will have access to rapid testing through a community health worker who will conduct rapid testing in the home or at a community-based location when indicated.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

3 sites across 3 countries: Kenya, South Africa, Zambia