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

COVID-19 Clinical Trial

— DTECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684887
• Other study ID #: EG0284
• Status: Completed
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: December 2023
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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: 1. 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. 2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: July 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Digital based contact tracing
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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	Cameroon Ministry of Public Health, Find

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 days
Secondary	Contacts testing positive for SARS-CoV-2 infection.	The proportion of contacts testing positive for SARS-CoV2 infection	10 days
Secondary	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	4 months
Secondary	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.	4 months
Secondary	Cost of the intervention	Cost estimates for using Mamal Pro digital contact tracing module to trace contacts, and cost per contact traced.	4 months
Secondary	Timely communication with contacts	Time (days) between receipt of contact list and contacts' call attempts	4 months
Secondary	SMS sent	Proportion of SMS delivered, (numerator: SMS sent, denominator: phone numbers)	4 months