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Digital Tools to Expand COVID-19 Testing in Exposed Individuals in Cameroon (DTECT)

Primary Purpose

COVID-19

Status
Active
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
Digital based contact tracing
Sponsored by
Elizabeth Glaser Pediatric AIDS Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Contact Tracing, mHealth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All contacts listed by individuals registered in the Mamal Pro app for testing, who test positive for SARS-CoV-2 in the selected health district testing units and health facilities in Cameroon. Exclusion Criteria: None

Sites / Locations

  • Bonanjo Integrated Health Center
  • Bonassama District COVID testing unit
  • Bonassama district hospital
  • Cité des palmiers District COVID testing unit
  • Cité des palmiers district hospital
  • CMA Bonamoussadi
  • CMA Nyala
  • CMA Soboum hospital
  • Deido District COVID testing unit
  • Deido district hospital
  • General Hospital Douala
  • Gynecological-Obstetric and Pediatric Hospital Douala (HGOPED)
  • Japoma District COVID testing unit
  • Laquintinie Hospital
  • Logbaba District COVID testing unit
  • Logbaba district hospital
  • Mbangue District COVID testing unit
  • Mboppi Baptist hospital
  • New Bell District COVID testing unit
  • New Bell district hospital
  • Nylon District COVID testing unit
  • Nylon district hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care model (SOC)

Intervention model (ITV)

Arm Description

This model is based on the standard of care recommended by the Cameroon National COVID-19 response program.

Implementation of the contact tracing using a digitalized process (addition of the Mamal Pro digital contact tracing module to the Mamal Pro app).

Outcomes

Primary Outcome Measures

Successful contact tracing
The primary outcome is the proportion of contacts declared by the index case who are successfully called by the district contact tracing unit and the proportion of contacts who receive SARS-CoV-2 testing, as per MOH standard testing procedures.

Secondary Outcome Measures

Contacts testing positive for SARS-CoV-2 infection.
The proportion of contacts testing positive for SARS-CoV2 infection
Feasibility of the intervention model of contact tracing
ease of use time to complete the process in the Mamal Pro digital contact tracing module integration with other clinic activities
Acceptability intervention model of contact tracing by the index cases (negative and positive) and health care workers
satisfaction of using the Mamal Pro digital contact tracing module compared with the usual standard of care approach challenges with this approach to contact tracing suggestions for improvement.
Cost of the intervention
Cost estimates for using Mamal Pro digital contact tracing module to trace contacts, and cost per contact traced.
Timely communication with contacts
Time (days) between receipt of contact list and contacts' call attempts
SMS sent
Proportion of SMS delivered, (numerator: SMS sent, denominator: phone numbers)

Full Information

First Posted
January 9, 2023
Last Updated
April 13, 2023
Sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Collaborators
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1. Study Identification

Unique Protocol Identification Number
NCT05684887
Brief Title
Digital Tools to Expand COVID-19 Testing in Exposed Individuals in Cameroon
Acronym
DTECT
Official Title
Digital Tools to Expand COVID-19 Testing in Exposed Individuals in Cameroon (DTECT Cameroon)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Collaborators
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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
According to the WHO, contact tracing - along with robust testing, isolation, and care of cases is a key strategy for interrupting chains of transmission of SARS-CoV-2 and reducing mortality associated with COVID-19. Contact tracing, however, has a number of challenges. These include incomplete identification of contacts, inefficiencies in paper-based reporting systems, complex data management requirements, and delays in the identification of contacts and testing of contacts. In many settings, contact tracing has proven to be too resource-intensive to implement at scale, especially with higher levels of community transmission, highlighting the need for more efficient contact tracing approaches. Digital tools afford the possibility of strengthening contact tracing for COVID-19, in a more efficient way. However, there is limited evidence of the effectiveness and impact of these tools in the COVID-19 response, including contact tracing. This study proposes to compare the cascade of care between two strategies for COVID-19 contact tracing of SARS-CoV-2 infected index patients in Cameroon. In one strategy (intervention), the health facilities and health district testing units will implement contact tracing using a digital tool developed to support the tracing and testing of contacts (addition of a digital contact tracing module to the main platform for COVID-19 testing in Cameroon (Mamal Pro app)). This strategy will be compared to the standard contact tracing process (control), based on the current routine approach (use of the Mamal Pro application without the digital contact tracing module).
Detailed Description
The study's general objective is to assess the effectiveness, feasibility, acceptability, and cost associated with the addition of a Mamal Pro digital contact tracing module to the Mamal Pro app in improving COVID-19 contact tracing and testing in Littoral, Cameroon. Specific objectives are: Primary objective: To determine the effectiveness of the use of a Mamal Pro digital contact tracing module added to the Mamal Pro app in improving COVID-19 contact tracing and testing compared to the SOC as measured by: The number and proportion of reported contacts who received SARS-CoV-2 testing. The number and proportion of contacts who are successfully reached by phone by MOH district contact tracing unit. The number and proportion of contacts testing positive for SARS-CoV-2 infection. The time from SARS-CoV-2 infected index patient identification of contacts to communication with the contact by the district contact tracing unit. Secondary objectives: To assess the feasibility and acceptability of the use of the Mamal Pro digital contact tracing module through structured interviews with MOH facility staff, district unit contract tracing teams, and individuals undergoing SARS-CoV-2 testing. To estimate the total cost of using the Mamal Pro contact tracing module for tracing SARS-CoV2 positive case contacts and cost per contact traced using the module.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Contact Tracing, mHealth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a cluster randomized trial conducted in eight (8) Health Districts with a high number of people being tested for SARS-CoV-2 in the Littoral region in Cameroon, comparing two strategies for COVID-19 contact tracing of SARS-CoV-2 infected index patients: The standard of care (SOC) implements the contact tracing using a manual process based on current routine approach (use of the Mamal Pro application without digital contact tracing module). The intervention (ITV) will implement the contact tracing using a digitalized process (addition of the Mamal Pro digital contact tracing module to the Mamal Pro app). The randomization unit (cluster) will be the district with selected testing units and/or health facilities where SARS-CoV-2 infected patients (index cases) are diagnosed.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
433 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care model (SOC)
Arm Type
No Intervention
Arm Description
This model is based on the standard of care recommended by the Cameroon National COVID-19 response program.
Arm Title
Intervention model (ITV)
Arm Type
Experimental
Arm Description
Implementation of the contact tracing using a digitalized process (addition of the Mamal Pro digital contact tracing module to the Mamal Pro app).
Intervention Type
Other
Intervention Name(s)
Digital based contact tracing
Intervention Description
Listing of contacts by SARS-CoV-2 positive individuals in Mamal Pro app + verification and validation by a health care worker. Immediate access to the contact list in Mamal Pro once validated by the health care worker. Contacts are immediately notified by text message automatically sent to all contacts with phone numbers and later called by the HCWs responsible for carrying out the contact tracing at the district level. Contacts will be invited to go to the nearest testing facilities/units to get tested. Those who are unable or refuse to come for testing are followed up by phone for 10 days for the occurrence of COVID-19 symptoms. Information about the contact tracing process during communication with contacts are recorded in Mamal Pro digital contact tracing module.
Primary Outcome Measure Information:
Title
Successful contact tracing
Description
The primary outcome is the proportion of contacts declared by the index case who are successfully called by the district contact tracing unit and the proportion of contacts who receive SARS-CoV-2 testing, as per MOH standard testing procedures.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Contacts testing positive for SARS-CoV-2 infection.
Description
The proportion of contacts testing positive for SARS-CoV2 infection
Time Frame
10 days
Title
Feasibility of the intervention model of contact tracing
Description
ease of use time to complete the process in the Mamal Pro digital contact tracing module integration with other clinic activities
Time Frame
4 months
Title
Acceptability intervention model of contact tracing by the index cases (negative and positive) and health care workers
Description
satisfaction of using the Mamal Pro digital contact tracing module compared with the usual standard of care approach challenges with this approach to contact tracing suggestions for improvement.
Time Frame
4 months
Title
Cost of the intervention
Description
Cost estimates for using Mamal Pro digital contact tracing module to trace contacts, and cost per contact traced.
Time Frame
4 months
Title
Timely communication with contacts
Description
Time (days) between receipt of contact list and contacts' call attempts
Time Frame
4 months
Title
SMS sent
Description
Proportion of SMS delivered, (numerator: SMS sent, denominator: phone numbers)
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All contacts listed by individuals registered in the Mamal Pro app for testing, who test positive for SARS-CoV-2 in the selected health district testing units and health facilities in Cameroon. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Tchakounte Youngui, MD, MPH
Organizational Affiliation
Elizabeth Glaser Pediatric AIDS Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Godfrey Woelk, PhD, MCOMMH
Organizational Affiliation
Elizabeth Glaser Pediatric AIDS Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bonanjo Integrated Health Center
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Bonassama District COVID testing unit
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Bonassama district hospital
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Cité des palmiers District COVID testing unit
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Cité des palmiers district hospital
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
CMA Bonamoussadi
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
CMA Nyala
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
CMA Soboum hospital
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Deido District COVID testing unit
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Deido district hospital
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
General Hospital Douala
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Gynecological-Obstetric and Pediatric Hospital Douala (HGOPED)
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Japoma District COVID testing unit
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Laquintinie Hospital
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Logbaba District COVID testing unit
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Logbaba district hospital
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Mbangue District COVID testing unit
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Mboppi Baptist hospital
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
New Bell District COVID testing unit
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
New Bell district hospital
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Nylon District COVID testing unit
City
Douala
State/Province
Littoral
Country
Cameroon
Facility Name
Nylon district hospital
City
Douala
State/Province
Littoral
Country
Cameroon

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Tools to Expand COVID-19 Testing in Exposed Individuals in Cameroon

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