Evaluation of the Integration of Ag-RDTs for COVID-19 in MNCH, HIV and TB Services in Cameroon and Kenya
Assessing the Effectiveness of Integration of Rapid Antigen Testing for SARS-CoV-2 in MNCH, HIV and TB Services in Cameroon and Kenya: A Pre- and Post- Implementation Evaluation (Effectiveness Study)
1 other identifier
observational
527,184
2 countries
2
Brief Summary
In many national Coronavirus Disease 2019 (COVID-19) response plans, including in Kenya and Cameroon, antigen detection tests are being used to improve access for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing. Targeting the populations most at risk for COVID-19 disease, including pregnant women, people living with HIV, and patients with tuberculosis (TB), and those who are the most vulnerable to transmission to other populations, can reduce the negative impact of the SARS-CoV-2 pandemic. Catalyzing COVID-19 Action (CCA) aims to strengthen detection by screening and diagnosing cases of SARS-CoV-2 in MNCH clinics, HIV clinics, and TB clinics and enhancing the management of COVID-positive cases. The main goal of the CCA project is to reduce deaths and severe illnesses caused by COVID-19 through early access to reliable diagnosis and effective treatment through innovative models of care. Both countries will conduct a pre- and post-implementation evaluation to compare screening, testing, care, and treatment of patients undergoing COVID-19 screening, testing, and treatment before and after the integration of facilities taking part in the CCA project.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2022
CompletedFirst Submitted
Initial submission to the registry
August 10, 2022
CompletedFirst Posted
Study publicly available on registry
August 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedJanuary 11, 2024
January 1, 2024
6 months
August 10, 2022
January 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion of pediatric and adult clinic attendees tested for SARS-CoV-2
Total number of clinic attendees tested with Ag-RDTs divided by the total number of clinic attendees
Study evaluation period (9 months)
SARS-CoV-2 detection rate
Number of Ag-RDTs testing SARS-CoV-2 positive attendees divided by total number of clinic attendees multiplied by 100 (#SARS-CoV-2 infections detected per 100 clinic attendees).
Study evaluation period (9 months)
Effect of integrated SARS-CoV-2 Ag-RDT testing on routine service delivery indicators
Comparison of corresponding monthly number of clinic attendees pre/post integration of Ag-RDTs into routine clinic services by taking a ratio of the total attendance and plotting the ratio over time
Study evaluation period (9 months)
Secondary Outcomes (2)
Factors associated with proportion of clinic attendees screened and tested with SARS-CoV-2 Ag-RDT, linked to care and treatment among the attendees following the integration of SARS-CoV-2 Ag-RDT in MNCH, HIV and TB clinics.
Study evaluation period (9 months)
Individual-level factors associated with SARS-CoV-2 infection, disease status, and outcomes
Study evaluation period (9 months)
Study Arms (3)
Maternal Newborn and Child Health (MNCH) Clinics
Clients attending for routine service delivery at MNCH clinics.
HIV Clinics
Patients attending for HIV clinic services
Tuberculosis (TB) Clinics
Patients attending TB clinic services.
Interventions
This study employs a quasi-experimental pre-and-post SARS-CoV-2 Ag-RDT integration design in all facilities implementing the 61 facilities in Cameroon and Kenya in Cameroon and Kenya.
Eligibility Criteria
The population will include attendees at the MNCH, HIV and TB clinics at all of the CCA project sites in Cameroon and Kenya. SARS-CoV-2 screening and testing will be offered to all attendees per the eligibility criteria below.
You may qualify if:
- MNCH services: all pregnant and breastfeeding women coming for antenatal care or post-natal care will be offered SARS-CoV-2 screening and testing; all children \> 2 years brought to the facility for routine immunization or under 5 years old clinics and their mother or caregivers will also be offered this service.
- HIV services: all children (2-17 years) and adults (\>18 years) attending HIV services, including those coming for a clinical or laboratory visit, those coming to collect medications or for counseling/support groups, and those who are accompanying patients (such as caregivers of HIV infected child, etc.) will be offered SARS-CoV-2 screening and testing.
- TB services: all children (2-17 years) and adults (\>18 years) attending TB services, including those coming for a clinical or laboratory visit, those coming to collect medications or for TB preventive therapy, and those who are accompanying patients (such as parent of a child, household contact, etc).
You may not qualify if:
- Clinic attendees from MNCH, HIV and TB clinics who tested positive for SARS-CoV-2 within the past two weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elizabeth Glaser Pediatric AIDS Foundationlead
- UNITAIDcollaborator
- Kenya Ministry of Healthcollaborator
- Ministry of Public Health, Camerooncollaborator
Study Sites (2)
Health facilities in Cameroon
Yaoundé, Cameroon
Health facilities in Kenya
Nairobi, Kenya
Related Publications (1)
Tchounga BK, Hoffman N, Masaba R, Djikeussi T, Ndimbii J, Moma E, Pearson S, Sikuku E, Gitau V, Argaw S, Tchendjou P, Siamba S, Kimani N, Zoung-Kanyi Bissek AC, Fokam J, Tiam A, Yemaneberhan A, Guay L, Bhatt NB, Machekano R. Integrating SARS-CoV-2 rapid antigen testing in maternal, neonatal and child health, HIV, and TB clinics in Kenya and Cameroon: outcomes from the Catalysing COVID-19 Action Project. BMJ Public Health. 2024 Aug 8;2(Suppl 1):e001015. doi: 10.1136/bmjph-2024-001015. eCollection 2024 Jul.
PMID: 41221322DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nilesh Bhatt, MD, PhD
Elizabeth Glaser Pediatric AIDS Foundation
- PRINCIPAL INVESTIGATOR
Rose Otieno Masaba, MD, MSc
Elizabeth Glaser Pediatric AIDS Foundation
- PRINCIPAL INVESTIGATOR
Boris Tchounga, MD, PhD
Elizabeth Glaser Pediatric AIDS Foundation
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2022
First Posted
August 12, 2022
Study Start
May 2, 2022
Primary Completion
October 31, 2022
Study Completion
September 30, 2023
Last Updated
January 11, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- All data will be made available for a minimum of 3 years from the end of the trial.
- Access Criteria
- For any data request reach out the study protocol Principal Investigator (nbhatt@pedaids.org)
Anonymized participant data will be made available upon requests directed to the corresponding author. Proposals will be reviewed and approved by the sponsor, investigator, and collaborators on the basis of scientific merit. After approval of a proposal, data can be shared through a secure online platform after signing a data-sharing agreement. All data will be made available for a minimum of 3 years from the end of the trial.