Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008485004797 Date of Approval: 06/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title TRACE - Transmission of Covid-19 in Crowded Environments
Official scientific title TRACE - Transmission of Covid-19 in Crowded Environments
Brief summary describing the background and objectives of the trial The overarching objective of this protocol is to understand and mitigate household transmission of SARs-CoV-2 infection in a low income, high density South African community setting. Data over an 8-month period will be used to determine the Ro for SARS-CoV-2 infection, rate of symptomatic disease, and impact of a community healthcare worker (CHW) administered household infection mitigation intervention (STOPCOV intervention). • Aim 1: To measure incidence and timing of transmission of SARS-CoV-2 to household contacts (HHC). SARS-CoV-2 transmission will be monitored using nasopharyngeal swabs for PCR and serology (IgM/IgG) assays in all Household Contacts (HHC) weekly for 1 month. Symptom checklists will be completed daily and collated weekly for each HHC. The proportion of patients and HHC who have symptoms vs asymptomatic disease will also be measured. • Aim 2: To investigate the effect of an intensive infection mitigation intervention (STOPCOV) administered by lay health care workers on SARS-CoV-2 household transmission. The proportion of transmissions to HHC of COVID19 cases assigned to the infection mitigation intervention arm compared with the households in the Enhanced Usual Care (EUC) arm will be measured. In addition, we will evaluate the effectiveness of the STOPCOV intervention on uptake of infection mitigation strategies, loneliness, stigma and social impact among households. Setting and population: The Klipfontein sub-district is a resource-limited, densely populated, high HIV disease burden areas in Cape Town. Newly diagnosed COVID19 cases will be identified from two sources: screening conducted in DTHF mobile screening units and local public sector clinics. Consecutive cases (n=120 and households) will be invited to participate. After enrolment, the household will be randomised to the STOPCOV intervention or enhanced usual care messaging.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TRACE
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 03/08/2020
Actual trial start date 14/09/2020
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date 31/08/2021
Anticipated target sample size (number of participants) 720
Actual target sample size (number of participants) 359
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group STOPCOV 3 times a week for 14 days 4 weeks. Intensified COVID19 infection mitigation intervention. Printed copies of PACK Home Volume 1 and 2. WhatsApp optimised versions of content delivered daily. Additional one off household assessment to establish relationship at baseline. Masks, hand sanitiser, bleach, gloves (to wear when using bleach). Plus on demand during follow-up. Scheduled support: Active phase (until 14 days after last person in household diagnosed): daily. Follow-up phase: 3 times a week for 7-14 days. Close-out: 5 days (to facilitate full integration into usual services). 60
Control Group Enhanced usual care On demand hotline service. On demand hotline service. Printed copies of PACK Home Volume 1 (Be coronavirus safe) and Volume 2 (COVID-19 Caring at home). 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligibility of index case inclusion: Individual >12 years Able to give assent if <18 years with parental/guardian consent Able to give consent> 18 years Self-isolating at home at the time of COVID diagnosis Eligibility of household contact inclusion: Living in the same household as index case Able to give assent if 12-17 years with parental/guardian consent Able to give consent≥ 18 years Index case exclusion: <12 years Unable to give consent household contact exclusion: Unable to give consent 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/07/2020 UCT human research ethics committee
Ethics Committee Address
Street address City Postal code Country
Main Rd, Observatory, Cape Town, 7925 Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome SARS-CoV-2 transmission will be monitored using nasopharyngeal swabs for SARS- CoV-2 PCR and serology (IgM/IgG) assays in all household contact weekly for 1 month. Symptom checklists will be completed daily and collated weekly for each household contact. Weeks 0, 1, 2, 3, 4.
Secondary Outcome The proportion of transmissions to HHC in the households of COVID cases assigned to the infection mitigation intervention arm compared with the households in the enhanced usual care (EUC) arm. Weeks 0, 1, 2, 3, 4.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Crossroads 1 clinic Klipfontein Road, Lower Crossroads Cape Town 7750 South Africa
Crossroads 2 Lansdowne Rd, Browns Farms Cape Town 7785 South Africa
Crossroads CDC Gwayi St, Crossroads Cape Town 7750 South Africa
Guguletu CHC NY3 and Ny 77, Guguletu Cape Town 7750 South Africa
Masincedani Clinic E Mjodo St, KTC Cape Town 7750 South Africa
Mzamomhle clinic 1679 Sagwityi St, Browns Farms Cape Town 7750 South Africa
Nyanga CDC Sithandathu Avenue, Nyanga Cape Town 7750 South Africa
Phumlani clinic Ngqabe Rd, Lower Crossroad Cape Town 7750 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Anna van Saksenlaan 51, 2593 HW Den Haag, Netherlands The Hague 2593 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Desmond Tutu Health Foundation Anzio Rd, Observatory Cape Town 7925 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Lara Fairall UCT, Woolsack Drive, Rondebosch Cape Town 7701 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator LindaGail Bekker Linda-Gail.Bekker@hiv-research.org.za 0832662876 Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa COO
Role Name Email Phone Street address
Public Enquiries Philip Smith Philip.Smith@hiv-research.org.za 0838602289 Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Scientist
Role Name Email Phone Street address
Scientific Enquiries Catherine Orrell Catherine.Orrell@hiv-research.org.za 0834561969 Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Medical Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We plan to share the de-identified individual participant data set to the Cape Town City Department of Health, the Western Cape Province Department of Health, and the South African National Department of Health. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol August 2021-July 2022 There will be controlled access to the data/documents with the gatekeepers being the Principal Investigator (PI) and the scientific protocol team, who will be responsible for deciding who may have access. Access to the data/documents must include prior ethical approval for secondary data analysis and the statistical methods for secondary data analysis must be vetted by a statistician. If access is requested during the conduct of the trial, it must be directed to all the members of the scientific protocol team.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 17/02/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 17/02/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information