3ACP Malawi: Enhancing access to COVID-19 tests. Africa, Asia, Americas COVID-19 Preparedness (3ACP)
| ISRCTN | ISRCTN17596113 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17596113 |
- Submission date
- 16/05/2023
- Registration date
- 26/05/2023
- Last edited
- 28/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The World Health Organization (WHO) has released guidelines supporting the use of rapid antigen tests for diagnosing SARS-CoV-2, including self-testing. These tests are commonly used in wealthy countries. However, the policies and practices regarding the use of antigen rapid diagnostic tests (Ag-RDTs) are not well-defined in most African countries, including Malawi. It is important to incorporate affordable rapid testing into regular healthcare services in order to promptly diagnose individuals at high risk of COVID-19 and make them eligible for oral antiviral treatments. While self-testing strategies using Ag-RDTs are already implemented in many COVID-19 testing approaches funded by governments in wealthy countries, self-test kits that can be purchased over the counter are not yet supported by policies in low- and middle-income countries for COVID-19 self-testing.
In this study, we aim to compare the number of confirmed COVID-19 cases diagnosed within five days of experiencing symptoms between two groups: one group receiving twice-weekly COVID-19 self-test kits and the other group receiving the standard of care. The standard of care includes considering the number of days off work due to suspected or confirmed COVID-19. All positive results from the COVID-19 self-tests will then undergo confirmation through polymerase chain reaction (PCR) testing and/or testing by a provider using Ag-RDTs (standard of care group). The goal is to detect infections early and enable effective infection prevention and care.
Who can participate?
Health care workers (HCWs) in Blantyre District i.e. both urban and rural public primary health centres. There will be six intervention health facilities under and six facilities under the standard of care arm.
What does the study involve?
For this study, we will conduct a controlled study with two groups, but the assignment to each group will not be random. In the standard of care group, we expect an average count of 20 and 35 confirmed cases of COVID-19 diagnosed within three months, with a standard deviation of 12. In the intervention group, the confirmed cases will be determined either by PCR testing or by repeating the antigen rapid diagnostic test (Ag-RDT) with the help of a professional. There will be a total of six clusters in each group, and each cluster will consist of 100 healthcare workers (HCWs).
What are the possible benefits and risks of participating?
-Potential direct benefits to you for participation in the study include easy access to COVID 19 testing, early detection COVID, and prevention of spread to high risk individuals you closely associate with.
-During participation in this study you may experience discomfort in your nose as the nasal swab is inserted. It is expected that this discomfort will go away soon after sample collection. If correct sampling technique is followed, the risk of complications from the procedure is low. Though rare, expected complications may be nasal bleeding or broken swab if excess pressure was applied. If you experience any of these problems, please report to study staff and you will be referred for appropriate treatment.
-You may also obtain a positive COVID-19 from your self-test, which may worry you. The researcher will discuss the meaning of the results with you and refer you to the national COVID-19 program where you will get help.
-On a more unlikely note, although we will conduct the study activities in private, it is possible that some people may know of your study participation and assume that you have COVID-19. This may affect your social or business relationships.
Where is the study run from?
Unitaid (Switzerland)
When is the study starting and how long is it expected to run for?
August 2022 to May 2023
Who is funding the study?
Unitaid (Switzerland)
Who is the main contact?
Dr Augustine Talumba Choko, achoko@mlw.mw
Contact information
Principal Investigator
Chipatala Rd
Box 30096
Blantyre
-
Malawi
 ORCID ID |
0000-0001-6095-9430 |
|---|---|
| Phone | +265 999577452 |
| achoko@mlw.mw |
Study information
| Study design | Non randomized cluster trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Screening |
| Participant information sheet | 43665 PIS_Consent _HCW v3.0 1June 2022.pdf |
| Scientific title | Evaluating the acceptability and feasibility of COVID-19 testing and linkage including self-testing: linked prospective studies in Malawi |
| Study acronym | 3ACP Malawi |
| Study objectives | There will be higher numbers of early COVID-19 diagnosed in the arm offering twice-weekly COVID-19 self-test kits to health care workers compared to the standard of care arm |
| Ethics approval(s) |
1. Approved 21/06/2022, College of Medicine Research and Ethics Committtee ; ), ref: (Private Bag 360, Chichiri, Blantyre 3, -, Malawi; +265 888 118 993; comrec@medcol.mw), ref: P.05/22/3649 2. Approved 31/05/2022, London School of Hygiene and Tropical Medicine (Keppel Street, London, WC1E 7HT, United Kingdom; +44 (0)20 7636 8636; ethics@lshtm.ac.uk), ref: 26874 3. Approved 08/11/2022, World Health Organization COVID Ethics Review Committee (20, Avenue Appia, Geneva 27, CH-1211, Switzerland; +41 22 791 21 11; ct_ethics@who.int), ref: CERC.0163 |
| Health condition(s) or problem(s) studied | SARS-COV-2 |
| Intervention | Standard of care (SOC) arm with professional-use rapid diagnostic tests (C19RDTs) for diagnostic testing of symptomatic HCWs. Intervention arm with SOC plus twice-weekly COVID-19 Ag-RDT self-testing (C19ST) for all health workers (HCWs). |
| Intervention type | Device |
| Pharmaceutical study type(s) | Self-test kit |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | ACON Flowflex™ COVID-19 Antigen Home Test |
| Primary outcome measure | Harmonic mean number of HCWs with confirmed COVID-19 measured through a count of number of HCWs with confirmed COVID-19 by PCR or rapid testing. |
| Secondary outcome measures | Measured by self-report at one month follow-up face-to-face interview: 1. Health care workers reporting any illness in the last 28 days 2. Health care workers taking time off work in the last 28 days 3. Health care workers having cough and fever in the last 28 days |
| Overall study start date | 01/08/2022 |
| Completion date | 30/05/2023 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 1,200 |
| Total final enrolment | 1081 |
| Key inclusion criteria | Healthcare workers shall be eligible to participate if they are: 1. Aged 18 years and above 2. All health workers employed by the above facilities, including nurses, doctors, clinic assistants, health surveillance assistants, clinical officers, community health workers and lay counsellors, administrators and support staff such as receptionists and porters. 3. Willing and able to give written informed consent |
| Key exclusion criteria | A healthcare worker shall be ineligible to participate if they: 1. Have tested positive for COVID-19 and are still within the isolation period 2. Have any medical contraindication to anterior nasal swab (e.g. bleeding disorders, recent facial trauma) |
| Date of first enrolment | 28/12/2022 |
| Date of final enrolment | 30/05/2023 |
Locations
Countries of recruitment
- Malawi
Study participating centres
265
Malawi
265
Malawi
265
Malawi
265
Malawi
265
Malawi
265
Malawi
265
Malawi
265
Malawi
265
Malawi
265
Malawi
Sponsor information
Charity
Unitaid – Global Health Campus
Chemin du Pommier 40, 5th floor
1218 Grand-Saconnex
Geneva
1218
Switzerland
| Phone | +41 22 791 12 00 |
|---|---|
| unitaid@who.int | |
| Website | https://unitaid.org/ |
"ROR" |
https://ror.org/05t99je22 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The results will be used to inform MoH on COVID-19 scale-up plans and will also be disseminated through Kamuzu University of Health Sciences, and through conference presentations and publication in peer-reviewed journals. The results will also be shared with participants and stake holders through the District Executive Committees (DEC), Health and Environment Committees (HEC), and the District Health Management Teams (DHMT) of Blantyre |
| IPD sharing plan | Data will be shared after anonymization and de-identification via https://datacompass.lshtm.ac.uk/ |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 01/06/2022 | 17/05/2023 | No | Yes |
| Protocol file | version 4.0 | 11/11/2022 | 17/05/2023 | No | No |
Additional files
Editorial Notes
28/06/2024: The intention to publish date was changed from 30/10/2023 to 30/10/2024.
29/04/2024: Total final enrolment was changed from 1080 to 1081.
08/06/2023: The overall end date was changed from 30/06/2023 to 30/05/2023.
17/05/2023: Trial's existence confirmed by WHO REC
