Clinical trial NCT06588790: Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries (DASH) - Phase II
Official title: Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries (DASH) - Phase II
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malaria Infection
Pregnancy
HIV
Diabetes
Hypertension
Keywords: Rapid diagnostic testing
Rapid testing
Self-testing
HIV
Malaria
Pregnancy
Home-based testing
community-based testing
Community Health Worker
Blood pressure
Hypertension
Diabetes
RDT
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: Centre for Infectious Disease Research in Zambia
name: Human Sciences Research Council
name: Bill and Melinda Gates Foundation (Funder)
First posted: 2024-09-19
Enrollment: 2250
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-arm household-randomized controlled implementation trial to assess two community-based intervention strategies for rapid diagnostic screening/testing, as compared to passive standard-of-care clinic-based screening/testing. Enrolled households will be randomized 1:1:1 to either one of two intervention arms, or the standard-of-care arm.
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Primary outcomes:
measure: Number of participants who self-report testing for Malaria and HIV
timeFrame: Over a period of 6 months.
Secondary outcomes:
measure: Number of participants who self-report testing for Malaria and HIV when indicated
timeFrame: Over a period of 6 months.
measure: Time from testing to treatment initiation or linkage to care among participants who tested positive for malaria or HIV
timeFrame: Over a period of 6 months
measure: Prevalence and incidence of positive malaria test results among participants asymptomatic and symptomatic for malaria among study populations in Zambia and Kenya
timeFrame: Over a period of 6 months.
measure: Diagnostic accuracy of a research use only malaria test for asymptomatic or symptomatic infection, as compared to rt-PCR testing from dried blood spots
timeFrame: Over a period of 6 months.
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
city: Durban
country: South Africa
facility: Human Sciences Research Council
city: Lusaka
country: Zambia
facility: Center for Infectious Disease Research in Zambia
Study officials:
affiliation: University of Washington
name: Paul Drain, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: