Diabetes, HIV, Hypertension, Malaria Infection, Pregnancy
Conditions
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
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.
Interventions
OTHERHome-based rapid testing
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.
OTHERCommunity health worker rapid testing
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.
Sponsors
Kenya Medical Research Institute
Centre for Infectious Disease Research in Zambia
Human Sciences Research Council
Bill and Melinda Gates Foundation
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
Countries
Kenya, South Africa, Zambia
Contacts
Primary ContactAmber Lauff
Backup ContactJennifer Morton
Outcome results
None listed