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NCT Number: NCT06588790

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

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)?

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Key information

Conditions

Malaria Infection Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders HIV Hypertension Infections Malaria Metabolic Diseases Mosquito-Borne Diseases Nutritional and Metabolic Diseases Parasitic Diseases Pregnancy Protozoan Infections Vascular Diseases Vector Borne Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute, Kisumu, Kenya

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Home-based rapid testing

Other

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.

Community health worker rapid testing

Other

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.

Primary outcomes

  1. Number of participants who self-report testing for Malaria and HIV

    Time frame: 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 outcomes

  1. Number of participants who self-report testing for Malaria and HIV when indicated

    Time frame: 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.

  2. Time from testing to treatment initiation or linkage to care among participants who tested positive for malaria or HIV

    Time frame: 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.

  3. Prevalence and incidence of positive malaria test results among participants asymptomatic and symptomatic for malaria among study populations in Zambia and Kenya

    Time frame: Over a period of 6 months.

  4. Diagnostic accuracy of a research use only malaria test for asymptomatic or symptomatic infection, as compared to rt-PCR testing from dried blood spots

    Time frame: Over a period of 6 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Lauff

CONTACT

[email protected]

206-520-3820

Jennifer Morton

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Centre for Infectious Disease Research in Zambia
  • Human Sciences Research Council
  • Kenya Medical Research Institute

Registry information

Acronym: DASH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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