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

Not Applicable

Not yet recruiting

• Conditions: Malaria Infection; Pregnancy; HIV; Diabetes; Hypertension
• Interventions: Other: Home-based rapid testing; Other: Community health worker rapid testing

• Registration Number: NCT06588790
• Lead Sponsor: University of Washington

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-07
• Study First Submitted QC: 2024-09-07
• Last Update Submitted: 2024-09-07
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Study Start: 2024-10
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2250

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)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based rapid self-testing	Home-based rapid testing	Participants randomized to the home-based testing arm will be provided with rapid diagnostic tests (RDTs) for priority conditions (malaria, HIV, pregnancy) that can be used on-demand and without prior approval, if/when indicated. In this study arm, testing will be conducted primarily by the participant. Participants will be taught to use applicable RDTs at the baseline visit and a stock of RDTs with instructions for use will be left in the household.
Community health worker (CHW)-facilitated rapid testing	Community health worker rapid testing	Participants who are randomized to the CHW-facilitated rapid testing arm will have access to in-home testing and information through the research team. The research team will include a CHW and/or nurse who has a supply of RDTs and can conduct RDT testing, if/when indicated. This study arm is intended to be similar to local CHW-facilitated healthcare delivery programs, which may vary by country. All testing that is conducted in this arm will be performed by the CHW (or research team).

Primary Outcome Measures

Name	Time	Method
Number of participants who self-report testing for Malaria and HIV	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).

Secondary Outcome Measures

Name	Time	Method
Number of participants who self-report testing for Malaria and HIV when indicated	Over a period of 6 months.	* Malaria: Self-report of malaria test for each testing indication event after baseline (presence of a fever after the baseline enrollment visit); * HIV: Self-report of HIV test for each testing indication event after baseline (possible HIV exposure as defined by screening indication); * Composite: Proportion of testing indication events after baseline that received appropriate screening/testing for malaria and HIV.
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	Time from testing to treatment initiation or linkage to care if/when indicated, for malaria and HIV, among those participants who had an indication for screening or testing.
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.
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.

Trial Locations

Locations (3)

Kenya Medical Research Institute; 🇰🇪 Kisumu, Kenya

Human Sciences Research Council; 🇿🇦 Durban, South Africa

Center for Infectious Disease Research in Zambia; 🇿🇲 Lusaka, Zambia