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Western Kenya Integrated COVID-19 Response

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Training of youth, community health assistants and community health workers.
Training clinicians in basic critical care and the management of severe COVID-19 cases
Sponsored by
Surgical Systems Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring youth, community health, digital tools, capacity building

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Youth aged 18 to 30 years old.
  • Active community health workers.
  • Facilities with oxygen capacity.

Exclusion Criteria:

  • Individuals younger than 18 or older than 30 years old.
  • Inactive community health workers.
  • Facilities without oxygen capacity.

Sites / Locations

  • Surgical Systems Research Group/Tropical Institute of Community Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Functional community health units

Non functional community health units

Health facilities with oxygen capacity

Health facilities without oxygen capacity

Arm Description

Community health units with active community health workers.

Community health units without active community health workers.

Health facility with regular oxygen capacity.

Outcomes

Primary Outcome Measures

Mortality
Mortality related to COVID-19
Number of confirmed COVID-19 cases in Siaya
Number of confirmed COVID-19 cases in Siaya

Secondary Outcome Measures

Full Information

First Posted
August 5, 2020
Last Updated
September 21, 2021
Sponsor
Surgical Systems Research Group
Collaborators
Wellcome Trust, Tropical Institute of Community Health
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1. Study Identification

Unique Protocol Identification Number
NCT04501458
Brief Title
Western Kenya Integrated COVID-19 Response
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
June 10, 2022 (Anticipated)
Study Completion Date
June 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Surgical Systems Research Group
Collaborators
Wellcome Trust, Tropical Institute of Community Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
youth, community health, digital tools, capacity building

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional community health units
Arm Type
Experimental
Arm Description
Community health units with active community health workers.
Arm Title
Non functional community health units
Arm Type
No Intervention
Arm Description
Community health units without active community health workers.
Arm Title
Health facilities with oxygen capacity
Arm Type
Experimental
Arm Description
Health facility with regular oxygen capacity.
Arm Title
Health facilities without oxygen capacity
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Training of youth, community health assistants and community health workers.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Training clinicians in basic critical care and the management of severe COVID-19 cases
Intervention Description
Training clinicians in basic critical care and the management of severe COVID-19 cases with concurrent maintenance of essential health services.
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality related to COVID-19
Time Frame
3 months
Title
Number of confirmed COVID-19 cases in Siaya
Description
Number of confirmed COVID-19 cases in Siaya
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Youth aged 18 to 30 years old. Active community health workers. Facilities with oxygen capacity. Exclusion Criteria: Individuals younger than 18 or older than 30 years old. Inactive community health workers. Facilities without oxygen capacity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neema Kaseje, MD
Organizational Affiliation
Surgical Systems Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical Systems Research Group/Tropical Institute of Community Health
City
Kisumu
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data will be available when results are reported.
IPD Sharing Time Frame
Immediately following publication; indefinitely.
IPD Sharing Access Criteria
Anyone with an approved proposal who wishes to access the data.
Links:
URL
https://wellcomeopenresearch.org/articles/6-15/v1
Description
Full protocol

Learn more about this trial

Western Kenya Integrated COVID-19 Response

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