Malaria InfectionDASHNCT06588790
Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries (DASH) - Phase II
A study testing Home-based rapid testing and Community health worker rapid testing in people with Malaria Infection and Pregnancy, run by University of Washington at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria Infection, Pregnancy, HIV
- What is being tested?
- Home-based rapid testing and Community health worker rapid testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,250 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
3 sites in 3 countries.
Jennifer Morton contact
3 sites in 3 countries
About this study
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)?
Read the 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
- Being tested
- Home-based rapid testing, Community health worker rapid testing
- 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
- Medical subject headings
- Diabetes Mellitus, Hypertension, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based rapid testingOther
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 testingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based rapid self-testing | Experimental | 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. Receives: Other: Home-based rapid testing |
| Community health worker (CHW)-facilitated rapid testing | Experimental | 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). Receives: Other: Community health worker rapid testing |
| Standard of care | No intervention | Households randomized to the standard of care arm will receive education on indications for testing for priority conditions. Participants will be instructed to seek screening/testing at the local clinic, if/when indicated. This study arm is intended to be similar to local routine health care delivery for those in the household, which may vary by country. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who self-report testing for Malaria and HIV
- 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).
Measured: Over a period of 6 months.
Secondary outcomes (4)
Number of participants who self-report testing for Malaria and HIV when indicated
- 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.
Measured: Over a period of 6 months.
Time from testing to treatment initiation or linkage to care among participants who tested positive for malaria or HIV
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.
Measured: Over a period of 6 months
Prevalence and incidence of positive malaria test results among participants asymptomatic and symptomatic for malaria among study populations in Zambia and Kenya
Measured: 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
Measured: Over a period of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria InfectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 2,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Centre for Infectious Disease Research in Zambia, Human Sciences Research Council, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Paul Drain, University of Washington
- Investigators
- Paul Drain, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588790
- Sponsor's protocol ID
- STUDY00019143
- Acronym
- DASH
- Status last verified
- Aug 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries (DASH) - Phase II
- ClinicalTrials.gov ID
- NCT06588790
- Acronym / sponsor ID
- DASH / STUDY00019143
- Conditions
- Malaria Infection, Pregnancy, HIV, Diabetes, Hypertension
- Keywords
- Rapid diagnostic testing, Rapid testing, Self-testing, HIV, Malaria, Pregnancy, Home-based testing, community-based testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,250 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Centre for Infectious Disease Research in Zambia, Human Sciences Research Council, Bill and Melinda Gates Foundation
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Home-based rapid self-testing | Experimental | Other: Home-based rapid testingParticipants 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 | Experimental | Other: Community health worker rapid testingParticipants 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). |
| Standard of care | No intervention | –Households randomized to the standard of care arm will receive education on indications for testing for priority conditions. Participants will be instructed to seek screening/testing at the local clinic, if/when indicated. This study arm is intended to be similar to local routine health care delivery for those in the household, which may vary by country. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based rapid testingParticipants 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 | Home-based rapid self-testing |
| Community health worker rapid testingParticipants 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. | Other | Community health worker (CHW)-facilitated rapid testing |
Primary outcome
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).
4 secondary outcomes
Number of participants who self-report testing for Malaria and HIV when indicated
Time frame: Over a period of 6 months.
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Morton contact
Paul Drain, MD, MPH principal investigator
University of Washington
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based rapid testing and Community health worker rapid testing in people with Malaria Infection and Pregnancy, run by University of Washington at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kenya, South Africa, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amber Lauff (206-520-3820, alauff@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who self-report testing for Malaria and HIV (time frame: Over a period of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.