An interventional study of Home-based rapid testing and Community health worker rapid testing in Malaria Infection, Pregnancy and HIV, sponsored by University of Washington. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Washington · Not applicable, Interventional, and Diagnostic
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:
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Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Home-based rapid testing
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).
Other: Community health worker rapid testing
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.
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.
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.
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.
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.
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 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.
Plan to share: Undecided
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This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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