An observational study in COVID-19, sponsored by Elizabeth Glaser Pediatric AIDS Foundation. Completed at 2 sites in 2 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Elizabeth Glaser Pediatric AIDS Foundation · Observational
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.
Background The use of simple and affordable rapid diagnostic antigen detection tests (Ag-RDT) to expand access to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing is being incorporated into many national Coronavirus Disease 2019 (COVID-19) response plans, including in Cameroon and Kenya. Ag-RDT are less expensive, highly sensitive, provide faster results, and require little technical support to diagnose SARS-CoV-2 infection. Targeting populations at high risk for COVID-19 and severe outcomes, and at risk of transmitting infection to other vulnerable populations has the potential to mitigate the propagation and effects of the SARS-CoV-2 pandemic. These high-risk populations include pregnant women, people living with HIV, and patients with tuberculosis. Data on SARS-CoV-2 infection in these populations in Africa and on the integration of Ag-RDT testing into Maternal Neonatal and Child Health (MNCH), HIV, and TB clinics are limited.
Objectives The main objective of this study is to evaluate the effectiveness of the integration of SARS-CoV-2 Ag-RDT in the MNCH, HIV and TB clinics in Cameroon and Kenya on SARS-CoV-2 testing and routine service delivery as compared to baseline. Investigators will also describe facility and individual factors that are associated with SARS-CoV-2 infection and the cascade of care and clinical outcomes in the post -integration period.
Methods A pre- and post-implementation evaluation design will be implemented in both countries to compare COVID-19 testing before and after the Ag-RDT integration. The study will be conducted in 61 purposively selected facilities (31 in Kenya and 30 in Cameroon). The population will include attendees at the MNCH, HIV and TB clinics at all the 61 facilities. SARS-CoV-2 screening will be performed for all attendees and testing offered to those who meet eligibility criteria as part of the MOH supported COVID-19 response. The study will consist of abstraction/extraction of routine facility service delivery records for secondary analysis of the program data only. There is no specific sample size but investigators estimate >10,000 clinic attendees will be screened.
Study Outcome The evidence generated by this evaluation will be used to support policy recommendations for improving COVID-19 testing, isolation, and treatment solutions in existing health platforms. This evaluation will allow for dissemination of results and subsequent adoption of proven models for integration and decentralization of COVID testing in multiple countries.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 527,184 is above the median of 268 across 3,208 observational 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.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clients attending for routine service delivery at MNCH clinics.
Diagnostic Test: Integration of SARS-CoV 2 Testing in HIV, MNCH and TB Clinics
Patients attending for HIV clinic services
Diagnostic Test: Integration of SARS-CoV 2 Testing in HIV, MNCH and TB Clinics
Patients attending TB clinic services.
Diagnostic Test: Integration of SARS-CoV 2 Testing in HIV, MNCH and TB Clinics
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.
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
Time frame: 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).
Time frame: 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
Time frame: Study evaluation period (9 months)
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.
Facility-level factors; facility level (hospital/health center/service entry points), location (region), support type, associated with screening and testing
Time frame: Study evaluation period (9 months)
Individual-level factors associated with SARS-CoV-2 infection, disease status, and outcomes
Distribution of client/patient demographic and clinical characteristics will be examined stratified by infection status using frequencies and proportion or means/medians as appropriate
Time frame: Study evaluation period (9 months)
Plan to share: Yes — 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.
Supporting information: 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)
Ran from May 2022 to primary completion in Oct 2022, 5 months.
Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 5 months is below that.
Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Elizabeth Glaser Pediatric AIDS Foundation