Western Kenya Integrated COVID-19 Response

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Training of youth, community health assistants and community health workers.; Other: Training clinicians in basic critical care and the management of severe COVID-19 cases

• Study Type: Interventional
• Enrollment (Anticipated): 200000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Surgical Systems Research Group/Tropical Institute of Community Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional community health units; Community health units with active community health workers.	Other: 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.
No Intervention: Non functional community health units; Community health units without active community health workers.
Experimental: Health facilities with oxygen capacity; Health facility with regular oxygen capacity.	Other: Training clinicians in basic critical care and the management of severe COVID-19 cases; Training clinicians in basic critical care and the management of severe COVID-19 cases with concurrent maintenance of essential health services.
No Intervention: Health facilities without oxygen capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality related to COVID-19	3 months
Number of confirmed COVID-19 cases in Siaya	Number of confirmed COVID-19 cases in Siaya	3 months

Collaborators and Investigators

• Sponsor: Surgical Systems Research Group
• Collaborators: Wellcome Trust; Tropical Institute of Community Health
• Investigators: Principal Investigator: Neema Kaseje, MD, Surgical Systems Research Group

Publications and helpful links

Helpful Links

• Full protocol

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Anticipated): June 10, 2022
• Study Completion (Anticipated): June 10, 2022

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: youth, community health, digital tools, capacity building
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No