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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

433 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2023-07-30

Brief Summary

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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

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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.

Conditions

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COVID-19

Keywords

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COVID-19 Contact Tracing mHealth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of care model (SOC)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Digital based contact tracing

Intervention Type OTHER

* 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boris Tchakounte Youngui, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Godfrey Woelk, PhD, MCOMMH

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Locations

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