A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx
NCT04991467
COVID-19, Coronaviridae Infections
The Bronx, New York, United States
View Trial DetailsNCT Number: NCT07337382
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
The Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, Victoria, Australia
This is a mixed methods longitudinal study of a cohort of 1000 participants for a 12 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.
Oversampling 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. To assess the feasibility, acceptability and implementation of new interventions designed to support a reduction in disease transmission, including testing strategies, we will recruit a small sub-sample of participants into a sub-studies that will assess implementation outcomes.
Objectives of the study are:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Community participants -
Exclusion criteria
Unable to provide consent -
Time frame: 18 months
Participants will complete behavioural questionnaires and diaries as binary daily measure of outcomes of compliance/non-adherence for each individual, determined by their ability to adhere to government regulations
Time frame: 18 months
Participants will complete behavioural questionnaires and diaries. e.g. Anxiety (using GAD scale: https://patient.info/doctor/generalised-anxiety-disorder-assessment-gad-7).
Time frame: 18 months
The behavioural questionnaire participants will be ask to complete include nominating the number of social network contacts per day.
Time frame: 18 months
The questionnaire participants will be ask to complete will include nominating the relationship with their contacts per day(i.e. partner, child, friend), and individuals COVID test status, providing detailed specifics of the projects social network data.
Time frame: 18 months
Participants responses to behavioural questionnaires and focus group discussions will be used as binary measurers; including but not limited to the number/proportion of participants who receive a score indicating accurate knowledge of government recommendations, receive a score of using COVID-19 prevention measures as recommended by the government.
Time frame: 18 months
The COVID 19 data will be analysed to determine the cases reported and if there are social contacts nominated in the questionnaires showing any linkage of cases. The social mixing patterns nominated of COVID19 cases, will be used to develop and refine mathematical models to improve precision and timeliness of dynamic transmission estimates.
Time frame: 18 months
Including but not limited to the number/proportion of participants with accurate knowledge of government recommendations and the number/proportion of participants using COVID-19 prevention measures as recommended by the government.
Time frame: 18 months
Participants of the Optimise main study who are diagnosed with COVID-19 and their contacts will be invited to participate in a sub study of saliva testing compared with deep nasal/throat swab testing for the diagnosis of COVID-19 using RT-PCR
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Other
Acronym: Optimise
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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