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

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

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).

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Digital based contact tracing

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 433
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cameroon
  • Littoral
    • Douala, Littoral, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care model (SOC); This model is based on the standard of care recommended by the Cameroon National COVID-19 response program.
Experimental: Intervention model (ITV); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• Collaborators: Find; Cameroon Ministry of Public Health
• Investigators: Principal Investigator: Boris Tchakounte Youngui, MD, MPH, Elizabeth Glaser Pediatric AIDS Foundation; Principal Investigator: Godfrey Woelk, PhD, MCOMMH, Elizabeth Glaser Pediatric AIDS Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; mHealth; Contact Tracing
• 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: EG0284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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