Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| Centre for Infectious Disease Research in Zambia | OTHER |
| Human Sciences Research Council | OTHER_GOV |
| Bill and Melinda Gates Foundation |
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who self-report testing for Malaria and HIV |
| Over a period of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who self-report testing for Malaria and HIV when indicated |
|
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amber Lauff | Contact | 206-520-3820 | alauff@uw.edu | |
| Jennifer Morton | Contact | jfmorton@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul Drain, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute | Kisumu | Kenya | ||||
| Human Sciences Research Council |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
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.
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. | 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 | 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. |
| Durban |
| South Africa |
| Center for Infectious Disease Research in Zambia | Lusaka | Zambia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
Not provided