COVID-19NCT05498727
Evaluation of the Integration of Ag-RDTs for COVID-19 in MNCH, HIV and TB Services in Cameroon and Kenya
An observational study of COVID-19, run by Elizabeth Glaser Pediatric AIDS Foundation at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Integration of SARS-CoV 2 Testing in HIV, MNCH and TB Clinics
- How many people
- 527,184 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 May 2022to 30 Sep 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- Clinic attendees from MNCH, HIV and TB clinics who tested positive for SARS-CoV-2 within the past two weeks.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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)
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.
Read the detailed description
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.
- Conditions
- COVID-19
- Being tested
- Integration of SARS-CoV 2 Testing in HIV, MNCH and TB Clinics
- Keywords
- Antigen rapid diagnostic test, Integration, COVID-19, Health Facilities, Africa, Effectiveness
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integration of SARS-CoV 2 Testing in HIV, MNCH and TB ClinicsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Newborn and Child Health (MNCH) Clinics | Clients attending for routine service delivery at MNCH clinics. Receives: Diagnostic Test: Integration of SARS-CoV 2 Testing in HIV, MNCH and TB Clinics | |
| HIV Clinics | Patients attending for HIV clinic services Receives: Diagnostic Test: Integration of SARS-CoV 2 Testing in HIV, MNCH and TB Clinics | |
| Tuberculosis (TB) Clinics | Patients attending TB clinic services. Receives: Diagnostic Test: Integration of SARS-CoV 2 Testing in HIV, MNCH and TB Clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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
Measured: 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.
Facility-level factors; facility level (hospital/health center/service entry points), location (region), support type, associated with screening and testing
Measured: 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
Measured: Study evaluation period (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start2 May 2022
- Primary completion31 Oct 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 527,184 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID, Kenya Ministry of Health, Ministry of Public Health, Cameroon
- Responsible party
- Sponsor
- Investigators
- Nilesh Bhatt, MD, PhD, Principal investigator, Elizabeth Glaser Pediatric AIDS FoundationRose Otieno Masaba, MD, MSc, Principal investigator, Elizabeth Glaser Pediatric AIDS FoundationBoris Tchounga, MD, PhD, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498727
- Sponsor's protocol ID
- EG0276
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 41221322
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05498727
- Acronym / sponsor ID
- EG0276
- Conditions
- COVID-19
- Keywords
- Antigen rapid diagnostic test, Integration, COVID-19, Health Facilities, Africa, Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527,184 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- UNITAID, Kenya Ministry of Health, Ministry of Public Health, Cameroon
- Study start
- 2 May 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maternal Newborn and Child Health (MNCH) Clinics | – | Diagnostic Test: Integration of SARS-CoV 2 Testing in HIV, MNCH and TB ClinicsClients attending for routine service delivery at MNCH clinics. |
| HIV Clinics | – | Diagnostic Test: Integration of SARS-CoV 2 Testing in HIV, MNCH and TB ClinicsPatients attending for HIV clinic services |
| Tuberculosis (TB) Clinics | – | Diagnostic Test: Integration of SARS-CoV 2 Testing in HIV, MNCH and TB ClinicsPatients attending TB clinic services. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Clinic attendees from MNCH, HIV and TB clinics who tested positive for SARS-CoV-2 within the past two weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integration of SARS-CoV 2 Testing in HIV, MNCH and TB ClinicsThis 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. | Diagnostic test | HIV Clinics, Maternal Newborn and Child Health (MNCH) Clinics, Tuberculosis (TB) Clinics |
Primary outcome
Proportion of pediatric and adult clinic attendees tested for SARS-CoV-2
Time frame: Study evaluation period (9 months)
Total number of clinic attendees tested with Ag-RDTs divided by the total number of clinic attendees
SARS-CoV-2 detection rate
Time frame: Study evaluation period (9 months)
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).
Effect of integrated SARS-CoV-2 Ag-RDT testing on routine service delivery indicators
Time frame: Study evaluation period (9 months)
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
2 secondary outcomes
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.
Time frame: Study evaluation period (9 months)
Individual-level factors associated with SARS-CoV-2 infection, disease status, and outcomes
Time frame: Study evaluation period (9 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 41221322Tchounga 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilesh Bhatt, MD, PhD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
Rose Otieno Masaba, MD, MSc principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
Boris Tchounga, MD, PhD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Elizabeth Glaser Pediatric AIDS Foundation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cameroon, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of pediatric and adult clinic attendees tested for SARS-CoV-2 (time frame: Study evaluation period (9 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05498727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.