Evaluation of the Integration of Ag-RDTs for COVID-19 in MNCH, HIV and TB Services in Cameroon and Kenya

September 8, 2026 updated by: Elizabeth Glaser Pediatric AIDS Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

527184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Yaoundé, Cameroon
        • Health facilities in Cameroon
  • Kenya
      • Nairobi, Kenya
        • Health facilities in Kenya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Clinic attendees from MNCH, HIV and TB clinics who tested positive for SARS-CoV-2 within the past two weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Maternal Newborn and Child Health (MNCH) Clinics
Clients attending for routine service delivery at MNCH clinics.
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.
HIV Clinics
Patients attending for HIV 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.
Tuberculosis (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Study evaluation period (9 months)
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).
Study evaluation period (9 months)
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
Study evaluation period (9 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Facility-level factors; facility level (hospital/health center/service entry points), location (region), support type, associated with screening and testing
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)
Distribution of client/patient demographic and clinical characteristics will be examined stratified by infection status using frequencies and proportion or means/medians as appropriate
Study evaluation period (9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Collaborators

UNITAID
Kenya Ministry of Health
Ministry of Public Health, Cameroon

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EG0276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

All data will be made available for a minimum of 3 years from the end of the trial.

IPD Sharing Access Criteria

For any data request reach out the study protocol Principal Investigator (nbhatt@pedaids.org)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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