Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments (TRACE)

Transmission of COVID19 in Crowded Environments

South Africa recorded it's first coronavirus disease 2019 (COVID19) case on March 5, 2020. In response to the COVID19 outbreak World Health Organisation recommendations, South Africa implemented non-pharmaceutical recommendations. The major risk mitigation factors recommended by World Health Organisation and others - physical distancing and hygiene - are extremely difficult to implement in much of Africa. The investigators will conduct a randomised controlled trial to investigate the effect of an infection mitigation intervention to assess the effect on household transmission of severe acute respiratory syndrome (SARS) coronavirus (CoV) 2 in household settings with an index patient diagnosed SARS-CoV-2 positive.

Study Overview

• Status: Completed
• Conditions: Covid19; Sars-CoV-2 Infection
• Intervention / Treatment: Other: STOPCOV

Detailed Description

The major risk mitigation factors recommended by World Health Organisation and others - physical distancing and hygiene - are extremely difficult to implement in much of Africa. Newly diagnosed SARS-CoV-2 index patients will be identified and recruited from a mobile clinic and local community clinics conducting SARS-CoV-2 testing. Index cases and their households will be invited to enroll. The study design is a type 2 hybrid cluster (household) randomised controlled trial, with outcomes assessed on index patients and their household contacts. 120 consecutively newly diagnosed index patients (GeneXpert severe acute respiratory syndrome coronavirus 2 PCR) and up to 6- 8 household contacts will be invited to participate in the trial as part of the prospective observational study evaluating transmission and symptoms. After completing consent, households will be randomised in a 1:1 ratio in blocks of 10 (60 households per group). Klipfontein is a resource-limited, densely populated, high HIV/tuberculosis disease burden areas in Cape Town. Newly diagnosed COVID19 cases will be identified from two sources: screening conducted in Desmond Tutu Health Foundation mobile screening units and local public sector clinics working closely with Desmond Tutu Health Foundation. Consecutive cases (n=120 cases and households) will be invited to participate in the randomised trial and prospective longitudinal follow up of up to 6- 8 household contacts. The contacts will be followed up after informed consent to SARS-CoV-2 screening, symptomatic questionnaires weekly up to 1 month. After enrolment, the household will be randomised to the infection mitigation intervention or enhanced usual care messaging. Baseline demographic, household characteristics questionnaire will be administered, and each household occupant invited to participate. Following consent procedures, household contacts (HHC) will be screened at baseline and weekly for 4 weeks for evidence of COVID19 infection. Specifically, the research team will conduct SARS-CoV-2 GeneXpert PCR testing and antibody serology. They will collate self- administered daily symptom checks on a weekly basis. The investigators will recruit 120 households over 1-11 months. The investigators will initiate a prospective longitudinal follow up of the household contacts of each case for 4 weeks in each case.

The investigators will calculate proportion of SARS-CoV-2 transmission from index cases in each household over 4- week period and describe the proportion of symptomatic and asymptomatic SARS-CoV-2 infection in a high density, low resourced community. Investigate the impact of the infection mitigation intervention by comparing incidence in households randomised to intervention versus standard of care. Secondary outcomes for the trial will include clinical outcomes (hospitalisations, death), linkages to care for people, psychosocial functioning, and stigma.

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • WC
    • Cape Town, WC, South Africa, 7925
      • Desmond Tutu Health Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• recently diagnosed SARS-CoV-2 positive
• 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

Exclusion Criteria:

• <12 years
• Unable to give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stop coronavirus (STOPCOV); A fieldworker will deliver the STOPCOV pack and personal protective equipment at baseline. The fieldworker will communicate with intervention households daily, delivering STOPCOV hygiene information.	Other: STOPCOV; Fieldworkers delivered an infection mitigation intervention which consisted of personal protective equipment and messaging on managing COVID19 and reducing onward transmission of SARS-CoV-2 infection.
No Intervention: Control; Participants received no additional messaging about managing COVID19 in the household.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 Infection	Number of participants with positive SARS-CoV-2 PCR result	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID19 Symptoms	Number of participants with SARS-CoV-2 serology antibody positive result	4 weeks

Collaborators and Investigators

• Sponsor: Desmond Tutu HIV Foundation
• Collaborators: Amsterdam Institute for Global Health and Development; University of Cape Town; European and Developing Countries Clinical Trials Partnership (EDCTP)
• Investigators: Principal Investigator: Linda-Gail Bekker, MBChB, PhD, Desmond Tutu Health Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): August 4, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: HREC 284 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No