An interventional study of Digital based contact tracing in COVID-19, sponsored by Elizabeth Glaser Pediatric AIDS Foundation. Completed at 22 sites in Cameroon. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by Elizabeth Glaser Pediatric AIDS Foundation · Not applicable, Interventional, and Prevention
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).
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:
Secondary objectives:
7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 433 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Elizabeth Glaser Pediatric AIDS Foundation is the lead sponsor of 30 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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).
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.
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.
Time frame: 10 days
Contacts testing positive for SARS-CoV-2 infection.
The proportion of contacts testing positive for SARS-CoV2 infection
Time frame: 10 days
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
Time frame: 4 months
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.
Time frame: 4 months
Cost of the intervention
Cost estimates for using Mamal Pro digital contact tracing module to trace contacts, and cost per contact traced.
Time frame: 4 months
Timely communication with contacts
Time (days) between receipt of contact list and contacts' call attempts
Time frame: 4 months
SMS sent
Proportion of SMS delivered, (numerator: SMS sent, denominator: phone numbers)
Time frame: 4 months
Plan to share: No
Ran from Oct 2022 to primary completion in Mar 2023, 5 months.
Of 1,295 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 5 months is below that.
Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Elizabeth Glaser Pediatric AIDS Foundation