Evaluation of serial self-testing supported contact tracing for COVID-19 in Brazil
| ISRCTN | ISRCTN91602092 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91602092 |
| Secondary identifying numbers | 1889025-1 |
- Submission date
- 06/10/2022
- Registration date
- 11/10/2022
- Last edited
- 07/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and Study Aims
Equitable access to quality, affordable diagnostics for COVID-19 is critical to health systems' abilities to identify infections early, isolate cases of active infection, and provide effective case management. Self-testing for COVID-19 may reduce the demand on health facilities while addressing many of the usual barriers to uptake of services, leading to timely testing of infectious individuals. It can also enable earlier diagnosis, which may affect peoples' behavior to minimize onward transmission and seek earlier clinical intervention, improving outcomes. Self-testing has been shown to be accurate with minimal user errors with the potential to increase equity by providing more testing options. However, many questions must be answered before a recommendation can be made for widespread implementation of this testing modality. This study aims to generate evidence about integrating self-testing into public health system programs and strategies, including evaluating the operational feasibility of using self-tests within the public health contact tracing system, evaluating the concordance of supervised self-tests with professionally-administered tests, and exploring barriers and facilitators patients and healthcare providers face when using self-tests for COVID-19.
Who can participate?
People aged 7 or older living in Porto Velho or Curitiba and testing positive for COVID-19 may enroll in the study. People aged 7 or older living in Porto Velho or Curitiba who have had close contact with someone testing positive for COVID-19 may enroll in the study.
What does the study involve?
Patients testing positive for COVID-19 will complete a contact elicitation interview. Contacts will be invited to participate in the study and randomized to intervention or control. Participants in the control group will complete a daily questionnaire for 10 days. Participants in the intervention group will perform a self-test daily and complete a daily questionnaire for 10 days.
What are the possible benefits and risks of participating?
The study does not pose any significant risk to participants beyond potential pain, discomfort, or nosebleed associated with a nasal swab. There is a risk participant information may become known to someone outside the study team, though all efforts are made to maintain confidentiality and data security. Participants in this study may benefit from convenient access to COVID-19 testing following an exposure.
Where is the study run from?
The primary enrollment center is CEPEM in Porto Velho, Rondonia, Brazil. PATH is headquartered in Seattle, Washington, USA.
When is the study starting and how long is it expected to run for?
December 2021 to July 2023
Who is funding the study?
PATH (USA) is sponsoring the study under an award from Unitaid (Switzerland)
Who is the main contact?
Dhelio Pereira, MD PhD, dbpfall@gmail.com
Emily Gerth-Guyette, MPH, egerthguyette@path.org
Contact information
Principal Investigator
Avenida Guaporé
215 Bairro Lagoa
Porto Velho
76812-329
Brazil
| Phone | +55 69-3219-6049 |
|---|---|
| dbpfall@gmail.com |
Public
2201 Westlake Ave
Seattle
98121
United States of America
| Phone | +1 (206) 285-3500 |
|---|---|
| egerthguyette@path.org |
Study information
| Study design | Multicenter two-arm 1:1 randomized pragmatic trial of a COVID-19 contact tracing program with and without serial self-testing |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Integration of serial self-testing into public health contact tracing programs: a pragmatic trial to assess the operational feasibility and impact of COVID-19 self-testing among exposed individuals in Brazil |
| Study objectives | Contact-tracing facilitated by serial self-testing identifies more positive COVID-19 cases among exposed close contacts than standard contact tracing over an approximately six-month period in Porto Velho, Brazil and Curitiba, Brazil. |
| Ethics approval(s) | 1. Approved 03/07/2022, The National Commission for Research Ethics (SRTV 701, Via W 5 Norte, lote D -Edifício PO 700, 3º andar –Asa Norte Brasília, Brazil; +55 (61) 3315-2951; conep@saude.gov.br), ref: 59179922.9.1001.0011 2. Approved 06/09/2022, World Health Organization Ethics Committee (Avenue Appia 201211 Geneva, Switzerland; +41 22 791 21 11; no email provided), ref: CERC.0167 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | The intervention will use SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDT) approved for self-testing by ANVISA in Brazil at the time of study start. Close contacts of confirmed positive cases of COVID-19 will be freely offered up to 10 self-tests and their use will be monitored through remote data collection. Close contacts will be randomized 1:1 within each site to intervention or control by index case using a sealed envelope. Arm 1 (Control) will proceed with contact tracing per standard practices, receiving a professionally-administered COVID-19 Ag-RDT following their notification of exposure. They will be followed up for 10 days and asked to complete a short survey each day. In addition to completing a supervised self-test and receiving a professionally-administered COVID-19 Ag-RDT following their notification of exposure, Arm 2 (Intervention) will receive 10 self-tests to self-administer for 10 days of follow up and asked to complete a short survey each day. Arm 2 participants will also be given up to 3 additional self-tests per household member to give to each household member (considered secondary exposures) to use as they see fit. Secondary exposures may opt to anonymously complete a short survey each time they use a self-test. Index cases may be considered an additional arm of this study; after completing the contact elicitation interview, index cases will be followed up for 10 days and asked to complete a short survey each day. |
| Intervention type | Behavioural |
| Primary outcome measure | Proportion of primary exposure close contacts who test positive per index case measured using COVID-19 Ag-RDT result reported on daily follow-up questionnaire Days 1-10. Self-reported COVID-19 self-test result reporting to a public health authority on daily follow-up questionnaire Days 1-10. Use of COVID-19 self-test by secondary exposures reported on optional anonymous survey upon use of self-test. Number of critical errors incurred during supervised self-test, measured per manufacturer instructions for use at baseline visit. Supervised self-test result and professionally-administered self-test result at baseline visit. |
| Secondary outcome measures | Measured as per the primary outcome measure: 1. Proportion of Ag-RDT positive contacts per index case who report adhering to recommended treatment, quarantine, or isolation guidelines at the time study is running 2. Proportion of exposed contacts in the self-testing group (Arm 2) who report test results as per local guidelines 3. Number of self-tests used by individuals with secondary exposures 4. Proportion of exposed contacts who perform a self-test per manufacturer instructions without critical errors, under supervision 5. Concordance of self-test result with professional use Ag-RDT test result |
| Overall study start date | 01/12/2021 |
| Completion date | 14/07/2023 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | All |
| Lower age limit | 7 Years |
| Sex | Both |
| Target number of participants | 750 |
| Total final enrolment | 793 |
| Key inclusion criteria | 1. Participants will be confirmed COVID-19 cases (index cases) and their associated close contacts. 2. Index cases will be 7 years of age or older. 3. Primary exposure close contacts will be enrolled in the main study, including children aged 7 and older. 4. Secondary exposure close contacts (household members of primary exposure close contacts enrolled in Arm 2) will be given self-tests to use in the observational sub-study. 5. A subset of patients/primary exposure close contacts, caregivers of primary exposure close contacts, health unit workers, and other key stakeholders will also have the option of participating in a usability workshop and/or focus group discussions. These participants will be aged 18 years and older |
| Key exclusion criteria | 1. Study site employee who is involved in the protocol and may have access to study-related data 2. Inappropriate to enroll 3. Previous study participant 4. Contraindication to nasal swab |
| Date of first enrolment | 05/12/2022 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- Brazil
Study participating centres
215 Bairro Lagoa
Porto Velho
76812-329
Brazil
Bairro Cristo Rei
Curitiba
80.050-250
Brazil
Sponsor information
Charity
2201 Westlake Ave
Seattle
9821
United States of America
| Phone | +1 (206) 285-3500 |
|---|---|
| dxinfo@path.org | |
| Website | https://path.org |
Funders
Funder type
Charity
Government organisation / Other non-profit organizations
- Alternative name(s)
- Program for Appropriate Technology in Health
- Location
- United States of America
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Stakeholders from the local municipalitesand the Ministry of Health will be engaged during protocol development to obtain study buy-in. These channels of communication will remain open throughout the conduct of the study to ensure continued engagement, and results will be shared back with these stakeholders. In addition to local results sharing, study findingswill be disseminated through a variety of channels, including the broader project consortium with Population Services International, the World Health Organization, and peer-reviewed publications. Research results will also be shared locally, at the participating facilities and health service units through debrief meetings and short reports. At the close of their participation, participants will also be sent information about where they can find final study results and be notified of dissemination outputs and events. |
| IPD sharing plan | Current IPD sharing plan as of 17/04/2024: The dataset analysed during the current study will be published and stored in a publicly available repository (Infectious Diseases Data Observatory). Data may be accessed by applying to the Data Access Committee (https://www.iddo.org/covid19/data-sharing/accessing-data). The type of data stored is tabular demographic and follow-up data related to the intervention, consisting of continuous and categorical variables, such as age, gender, education level, professional COVID test result, COVID self-test result, masking and isolation behavior. The timing for availability is when these data have been submitted and undergone curation by the IDDO team. Consent from participants was obtained as stated in the protocol and these data were deidentified before submission in the repository. Previous IPD sharing plan: De-identified data used in published analyses will be made available in accordance with open-access data and journal policies. Additional details regarding data sharing will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 31/08/2022 | 11/10/2022 | No | No |
| Protocol article | 04/10/2023 | 05/10/2023 | Yes | No | |
| Statistical Analysis Plan | version 1.1 | 01/10/2023 | 14/11/2023 | No | No |
| Basic results | 07/05/2024 | No | No |
Additional files
Editorial Notes
07/05/2024: The basic results have been uploaded as an additional file.
17/04/2024: The individual participant data (IPD) sharing plan was changed and the summary was added.
14/11/2023: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The total final enrolment was added.
05/10/2023: Publication reference added.
06/06/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 15/06/2023 to 30/06/2023.
2. The overall study end date was changed from 30/06/2023 to 14/07/2023.
05/04/2023: The following changes have been made:
1. The recruitment start date has been changed from 21/11/2022 to 05/12/2022.
2. The recruitment end date has been changed from 30/04/2023 to 15/06/2023.
08/12/2022: The sponsor's email address was updated.
07/12/2022: The recruitment start date has been changed from 21/11/2022 to 05/12/2022.
11/10/2022: Trial's existence confirmed by WHO.
