INTEGrating Ag-RDTs for COVID-19 in MNCH,HIV and TB Services in Cameroon and Kenya
INTEGRATE
INTEGrating Rapid Antigen TEsting for SARS-CoV-2 in Maternal, Neonatal and Child Health, HIV and Tuberculosis Services in Cameroon and Kenya: A Cluster Randomized Trial of Two Models
1 other identifier
interventional
152,082
2 countries
2
Brief Summary
Integration of antigen-detecting rapid diagnostic tests (Ag-RDT) for COVID-19 into services that provide care for vulnerable populations such as pregnant women, children, people with HIV infection, and patients with tuberculosis (TB) will identify more people with Coronavirus infection. This will allow for earlier treatment and tracing of contacts to decrease the spread of the coronavirus. This study is looking at two models for providing the testing in Maternal, Newborn and Child Health (MNCH), Tuberculosis (TB) and HIV clinics in Cameroon and Kenya. In some clinics, attendees with be screened for Coronavirus symptoms and history of exposure and if positive they will receive the rapid coronavirus test right in the clinic. In other facilities, all people attending the clinic with be provided with the coronavirus testing even if they screen negative to see how many people are infected but do not show any symptoms. Hospitalized and non-hospitalized patients with the coronavirus infection will be followed to document their illness and health outcomes. We will also ask health care workers about how well the testing in these clinics is working and what are some of their challenges, and collect information about the costs associated with both the models of testing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started May 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2022
CompletedStudy Start
First participant enrolled
May 17, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedJanuary 11, 2024
January 1, 2024
11 months
May 17, 2022
January 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
SARS-CoV-2 case detection rate
Number of SARS-CoV-2 infections detected per 100 clinic attendees
6 months
Proportion of contacts tested for SARS-CoV2 infection
Number of contacts tested per 100 clinic attendees
6 months
Proportion of contacts identified with SARS-CoV-2 infection
Number of contacts testing positive for SARS-CoV2 infection as a proportion of the number contacts tested
6 months
Secondary Outcomes (4)
Testing rates, linkage to care, disease progression, treatment and final outcome for SARS-CoV-2 infected patients
6 months
Linkage to care for SARS-CoV-2 infected patients
6 months
Disease progression, treatment and final outcome for SARS-CoV-2 infected patients
6 months
Feasibility and acceptability of integrating the model and the cost of the test-all versus screen-and-test models
6 months
Study Arms (2)
Test All
EXPERIMENTALMNCH, HIV, and TB clinic attendees are offered SARS-CoV-2 testing regardless of symptoms.
Screen and Test
NO INTERVENTIONPopulations are screened and tested for SARS-CoV-2 according to the MOH testing guidelines model.
Interventions
In the "test all" arm, SARS-CoV-2 infection screening questions will be administered to all clinic attendees followed by SARS-CoV-2 Ag-RDT testing irrespective of screening results.
Eligibility Criteria
You may qualify if:
- Age ≥ 2 years.
- Identified as SARS-CoV-2 positive during the study.
- Willing and able to provide informed consent or parental consent +/- assent for the study participation according to the national guidelines
You may not qualify if:
- Significant medical or psychological condition that would preclude active study participation or ability to provide informed consent.
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 (2)
Bhatt N, Masaba RO, Tchounga B, Yemaneberhan A, Simo L, Katcho TD, Ndimbii J, Siamba S, Mwancha-Kwasa C, Epee E, Zoung-Kanyi Bissek AC, Pearson S, Tiam A, Guay L, Machekano R. Integrating SARS-CoV-2 rapid antigen testing in maternal, neonatal and child health, HIV and tuberculosis services in Cameroon and Kenya: a cluster randomised trial of two testing models. BMJ Public Health. 2025 Jul 13;2(Suppl 1):e000873. doi: 10.1136/bmjph-2023-000873. eCollection 2024 Jul.
PMID: 41190341DERIVEDNdimbii J, Djikeussi T, Kana R, Siamba S, Machekano R, Bhatt N, Yemaneberhan A, Pearson S, Wanyama E, Mwancha-Kwasa C, Epee E, Tchounga B, Tiam A, Masaba RO. Assessing time requirements of two models of SARS-CoV-2 screening and testing in routine healthcare services in Kenya and Cameroon: a descriptive study. BMJ Public Health. 2025 Mar 22;2(Suppl 1):e001154. doi: 10.1136/bmjph-2024-001154. eCollection 2024 Jul.
PMID: 40599610DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nilesh Bhatt, MD,MMed,PhD
Elizabeth Glaser Pediatric AIDS Foundation
- PRINCIPAL INVESTIGATOR
Boris Tchounga, MD, PhD
Elizabeth Glaser Pediatric AIDS Foundation
- PRINCIPAL INVESTIGATOR
Rose Otieno Masaba, MD, MSc
Elizabeth Glaser Pediatric AIDS Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2022
First Posted
May 19, 2022
Study Start
May 17, 2022
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
January 11, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- All data will be made available for a minimum of 3 years from the end of the trial.
- Access Criteria
- Contact the 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.