Covid19NCT04501458
Western Kenya Integrated COVID-19 Response
A study testing Training of youth, community health assistants and community health workers. and Training clinicians in basic critical care and the management of severe COVID-19 cases in people with Covid19, run by Surgical Systems Research Group at 1 site in Kenya.
Trial summary
To respond to the COVID-19 pandemic, investigators will be deploying community health workers, equipped with mobile technology, and accompanied by youth to visit households door to door to screen for symptoms of COVID-19, isolate, test, and manage suspected cases of COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Training of youth, community health assistants and community health workers. and Training clinicians in basic critical care and the management of severe COVID-19 cases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200,000 participants
- Where
- 1 siteKenya
- Study dates
- 10 Aug 2020to 10 Jun 2022
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Youth aged 18 to 30 years old.
- Active community health workers.
- Facilities with oxygen capacity.
Who cannot join
- Individuals younger than 18 or older than 30 years old.
- Inactive community health workers.
- Facilities without oxygen capacity.
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Surgical Systems Research Group/Tropical Institute of Community Health
Kisumu
About this study
Official title: Western Kenya Integrated COVID-19 Response Leveraging the Community Health Strategy, Youth, and Technology to Flatten the COVID-19 Curve and Improve COVID-19 Case Detection, Isolation and Management in Western Kenya
To respond to the COVID-19 pandemic, investigators will be deploying community health workers, equipped with mobile technology, and accompanied by youth to visit households door to door to screen for symptoms of COVID-19, isolate, test, and manage suspected cases of COVID-19. The community health workers and youth will educate households about preventive measures including frequent handwashing and home management of mild cases. Simultaneously, investigators will work with nurses, doctors, and clinical officers, to test and treat more severe cases of COVID-19 in health facilities. Our goals are: to visit every household in Siaya county covering a population of close to 1 million, and to train and support health workers working in 32 health facilities with oxygen capacity in Siaya to reduce the morbidity and mortality related to COVID19 and other conditions.
- Conditions
- Covid19
- Being tested
- Training of youth, community health assistants and community health workers., Training clinicians in basic critical care and the management of severe COVID-19 cases
- Keywords
- youth, community health, digital tools, capacity building
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training of youth, community health assistants and community health workers.Other
Training of youth, community health assistants, and community health workers in the screening, detection, contact tracing, prevention, and management of COVID-19 with concurrent maintenance of essential health services.
Training clinicians in basic critical care and the management of severe COVID-19 casesOther
Training clinicians in basic critical care and the management of severe COVID-19 cases with concurrent maintenance of essential health services.
| Study group | Role | What they receive |
|---|---|---|
| Functional community health units | Experimental | Community health units with active community health workers. Receives: Other: Training of youth, community health assistants and community health workers. |
| Non functional community health units | No intervention | Community health units without active community health workers. |
| Health facilities with oxygen capacity | Experimental | Health facility with regular oxygen capacity. Receives: Other: Training clinicians in basic critical care and the management of severe COVID-19 cases |
| Health facilities without oxygen capacity | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality related to COVID-19
Measured: 3 months
Number of confirmed COVID-19 cases in Siaya
Number of confirmed COVID-19 cases in Siaya
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start10 Aug 2020
- Primary completion10 Jun 2022 (estimated)
- Study completion10 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surgical Systems Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Tropical Institute of Community Health
- Responsible party
- Principal investigator, Neema Kaseje, Surgical Systems Research Group
- Investigators
- Neema Kaseje, MD, Principal investigator, Surgical Systems Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501458
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2021
- First submitted
- 5 Aug 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be available when results are reported.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Western Kenya Integrated COVID-19 Response Leveraging the Community Health Strategy, Youth, and Technology to Flatten the COVID-19 Curve and Improve COVID-19 Case Detection, Isolation and Management in Western Kenya
- ClinicalTrials.gov ID
- NCT04501458
- Acronym / sponsor ID
- 001
- Conditions
- Covid19
- Keywords
- youth, community health, digital tools, capacity building
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Surgical Systems Research GroupUniversity, hospital or other
- Collaborators
- Wellcome Trust, Tropical Institute of Community Health
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 10 Jun 2022 (estimated)
- First posted
- 6 Aug 2020 (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.
To respond to the COVID-19 pandemic, investigators will be deploying community health workers, equipped with mobile technology, and accompanied by youth to visit households door to door to screen for symptoms of COVID-19, isolate, test, and manage suspected cases of COVID-19. The community health workers and youth will educate households about preventive measures including frequent handwashing and home management of mild cases. Simultaneously, investigators will work with nurses, doctors, and clinical officers, to test and treat more severe cases of COVID-19 in health facilities. Our goals are: to visit every household in Siaya county covering a population of close to 1 million, and to train and support health workers working in 32 health facilities with oxygen capacity in Siaya to reduce the morbidity and mortality related to COVID19 and other conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Functional community health units | Experimental | Other: Training of youth, community health assistants and community health workers.Community health units with active community health workers. |
| Non functional community health units | No intervention | –Community health units without active community health workers. |
| Health facilities with oxygen capacity | Experimental | Other: Training clinicians in basic critical care and the management of severe COVID-19 casesHealth facility with regular oxygen capacity. |
| Health facilities without oxygen capacity | No intervention | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Youth aged 18 to 30 years old.
- Active community health workers.
- Facilities with oxygen capacity.
Key exclusion criteria (3 listed)
- Individuals younger than 18 or older than 30 years old.
- Inactive community health workers.
- Facilities without oxygen capacity.
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 |
|---|---|---|
| Training of youth, community health assistants and community health workers.Training of youth, community health assistants, and community health workers in the screening, detection, contact tracing, prevention, and management of COVID-19 with concurrent maintenance of essential health services. | Other | Functional community health units |
| Training clinicians in basic critical care and the management of severe COVID-19 casesTraining clinicians in basic critical care and the management of severe COVID-19 cases with concurrent maintenance of essential health services. | Other | Health facilities with oxygen capacity |
Primary outcome
Mortality
Time frame: 3 months
Mortality related to COVID-19
Number of confirmed COVID-19 cases in Siaya
Time frame: 3 months
Number of confirmed COVID-19 cases in Siaya
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Full protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified participant data will be available when results are reported.
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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.
Neema Kaseje, MD principal investigator
Surgical Systems Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training of youth, community health assistants and community health workers. and Training clinicians in basic critical care and the management of severe COVID-19 cases in people with Covid19, run by Surgical Systems Research Group at 1 site in Kenya.
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 3 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 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 3 months). The study lists 2 primary outcomes in all. 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 22 Sep 2021.