Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries (DASH) - Phase II
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorUniversity of Washington
About this trial
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)?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Home-based rapid testing
Other interventionParticipants 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 interventionParticipants 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.
Treatment groups
2,250 Participants
are divided into 3 treatment groupsGroup A: Home-based rapid self-testingExperimental treatment 1 intervention
Group B: Community health worker (CHW)-facilitated rapid testingExperimental treatment 1 intervention
Group C: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Over a period of 6 months.Secondary outcomes
1
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.
Time frame
Over a period of 6 months.2
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.
Time frame
Over a period of 6 months3
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Kenya Medical Research Institute
Collaborator
Centre for Infectious Disease Research in Zambia
Collaborator
Human Sciences Research Council
Collaborator
Bill and Melinda Gates Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: