Clinical trial NCT05684887: Digital Tools to Expand COVID-19 Testing in Exposed Individuals in Cameroon
Official title: Digital Tools to Expand COVID-19 Testing in Exposed Individuals in Cameroon (DTECT Cameroon)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Contact Tracing
mHealth
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Find
name: Cameroon Ministry of Public Health
First posted: 2023-01-13
Enrollment: 433
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: Successful contact tracing
timeFrame: 10 days
Secondary outcomes:
measure: Contacts testing positive for SARS-CoV-2 infection.
timeFrame: 10 days
measure: Feasibility of the intervention model of contact tracing
timeFrame: 4 months
measure: Acceptability intervention model of contact tracing by the index cases (negative and positive) and health care workers
timeFrame: 4 months
measure: Cost of the intervention
timeFrame: 4 months
measure: Timely communication with contacts
timeFrame: 4 months
measure: SMS sent
timeFrame: 4 months
Other outcomes:
Locations:
city: Douala
country: Cameroon
facility: Bonanjo Integrated Health Center
state: Littoral
city: Douala
country: Cameroon
facility: Bonassama District COVID testing unit
state: Littoral
city: Douala
country: Cameroon
facility: Bonassama district hospital
state: Littoral
city: Douala
country: Cameroon
facility: Cité des palmiers District COVID testing unit
state: Littoral
city: Douala
country: Cameroon
facility: Cité des palmiers district hospital
state: Littoral
city: Douala
country: Cameroon
facility: CMA Bonamoussadi
state: Littoral
city: Douala
country: Cameroon
facility: CMA Nyala
state: Littoral
city: Douala
country: Cameroon
facility: CMA Soboum hospital
state: Littoral
city: Douala
country: Cameroon
facility: Deido District COVID testing unit
state: Littoral
city: Douala
country: Cameroon
facility: Deido district hospital
state: Littoral
city: Douala
country: Cameroon
facility: General Hospital Douala
state: Littoral
city: Douala
country: Cameroon
facility: Gynecological-Obstetric and Pediatric Hospital Douala (HGOPED)
state: Littoral
city: Douala
country: Cameroon
facility: Japoma District COVID testing unit
state: Littoral
city: Douala
country: Cameroon
facility: Laquintinie Hospital
state: Littoral
city: Douala
country: Cameroon
facility: Logbaba District COVID testing unit
state: Littoral
city: Douala
country: Cameroon
facility: Logbaba district hospital
state: Littoral
city: Douala
country: Cameroon
facility: Mbangue District COVID testing unit
state: Littoral
city: Douala
country: Cameroon
facility: Mboppi Baptist hospital
state: Littoral
city: Douala
country: Cameroon
facility: New Bell District COVID testing unit
state: Littoral
city: Douala
country: Cameroon
facility: New Bell district hospital
state: Littoral
city: Douala
country: Cameroon
facility: Nylon District COVID testing unit
state: Littoral
city: Douala
country: Cameroon
facility: Nylon district hospital
state: Littoral
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Boris Tchakounte Youngui, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Godfrey Woelk, PhD, MCOMMH
role: PRINCIPAL_INVESTIGATOR
References: