Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588790
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries DASH - Phase II
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries DASH - Phase II
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DASH
Brief 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 caretreatment 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
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 caretreatment 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 diagnosistreatment 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
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 diagnosistreatment 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None