Clinical trial NCT05323799: The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)
Official title: The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Lead sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteer participants over the age of 18 years in Victoria, Australia

Brief summary: The Australian government swift interventions and actions early to the COVID 19 epidemic included enforced quarantine, isolation, varying degrees of social and physical distancing measures, travel restrictions, community level testing and enhanced contact tracing models which effected the trajectory of the epidemic impact. While the search for effective therapeutics and vaccines continues, it is important to understand how to effectively implement and optimise the current public health interventions available; application of traditional contact tracing , contributions of new contact tracing mobile phone applications, community level testing and use of specific fit for purpose diagnostic tests; to screen, detect and provide evidence of infection clearance.

While the suppression measures have been effective on disease transmission rates, it has had economic, social and non COVID-19 health costs impacts. As community restrictions change it will be important to monitor and evaluate the effectiveness of these key interventions. This is a longitudinal study that will follow the experience and behaviors of 2 key risk populations impacted by COVID-19 transmission containment measures.

Detailed description: This is a mixed methods longitudinal study of a cohort of 1000 participants for a 18 month period. Victorian adults from three key risk populations will be recruited into two longitudinal cohort groups. It will follow the experiences and behaviors of the groups; Recruitment group 1/Seed set 1 - recently diagnosed 'COVID-19 cases' (Group 1) and their social network with up to 2 waves of /Key people, will be followed up for 1 month initially with specific monitoring tools before they will transition into ongoing follow up and monitoring as recruitment group 2 Recruitment group 2/Seed set 2 - people from the general community that are not currently infected with COVID19 'Group 2' that are practicing physical distancing and represent specific key risk groups, and their social network with up to 2 waves of Key people.

Over sampling of vulnerable populations including people with disabilities, single parents and people living alone will be conducted across all groups. Individuals may be invited to participate in more than one cohort when they change between risk population definitions.

The project aims to meet the following objectives using a longitudinal cohort design and a mixed method of qualitative and quantitative tools to enable us to assess changes within individuals over time and to assess the influence of social networks on their health, well-being, attitudes and perceptions.

Objectives of the study are:

1. To assess adherence to government intervention strategies (i.e. early testing, isolation and physical distancing) and identify factors that promote/inhibit compliance to intervention strategies designed to reduce transmission.
2. To better understand, assess and monitor the unintended health, social and economic consequences of the government interventions to control COVID-19 transmission
3. To collect and collate empirical data regarding transmissions dynamics, social contacts and mixing patterns of COVID19 cases , their contacts and key vulnerable groups to develop and refine mathematical models that will improve the precision and timeliness of dynamic transmission estimates.

Eligibility criteria: Inclusion Criteria:

* Community participants

Exclusion Criteria:

* Unable to provide consent

Primary outcomes:
measure: Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures
timeFrame: 18 months
measure: Change from response in baseline questionnaires depicting what are the unintended health, social and economic consequences of the government response to control COVID19 transmission
timeFrame: 18 months
measure: What are the social contacts and mixing patterns of COVID-19 cases
timeFrame: 18 months
measure: What are the types of social contacts and mixing patterns of COVID-19 cases
timeFrame: 18 months
measure: Measure of the efficacy of government interventions
timeFrame: 18 months
Secondary outcomes:
measure: Collect and collate empirical data of COVID19 cases, contacts and key vulnerable groups
timeFrame: 18 months
measure: Assess the effectiveness of government interventions to reduce COVID-19 transmission from questionnaire responses from cohort participants
timeFrame: 18 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Macfarlane Burnet Institute for Medical Research and Public Health
state: Victoria
Study officials:
affiliation: The Macfarlane Burnet Institute for Medical Research and Public Health
name: Margaret Hellard
role: PRINCIPAL_INVESTIGATOR
References: