Public Perception and Policy for SARS-CoV-2 Whole Genome Sequencing and Genomics for All

May 31, 2024 updated by: Rina Agustina, Indonesia University

Closing the Gap in Public Perception and Policy for SARS-CoV-2 Whole Genome Sequencing and Genomics for All

Gap in understanding undermines government and public support for SC2-WGS, and other wide-scale genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing) as a routine part of the pandemic response, especially in low- and middle-income countries. However, such gaps can be closed with systematic efforts to define and measure specific misperceptions, and subsequently design and use targeted messages and promotional materials. We propose here in the following specific aims to first determine the entire set of beliefs and emotions regarding SC2-WGS and other genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing), then identify and measure limiting belief constructs, and then create social media and communication media to address and overcome limiting beliefs strategically. The goal is to increase public and policymaker support for SC2-WGS and other genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing) resources and actions for pandemic control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Implementing WGS, it is advisable to involve a variety of relevant actors and to consider the opinions of various stakeholders, including those who are not professionals in the field. This might resolve the implementation problem that could occur if psychological and social dimensions or, in other words, not strictly scientific criteria are not adequately integrated in decision making concerning complex issues such as innovations in genetics. In most cases, the reaction towards genetic information corresponds with a specific personal view of how to handle medical information and thus amplifies already existing mental phenomena (fear, stress, worries, etc.), tendencies of self-improvement and self-care and curiosity and playfulness.38 In the Study from Lewis et al, investigated in this relation the specific personality traits of participants of the first implementations of WGS, who were characterized as optimistic and resilient. This is a phenomenon often found in the group of early adopters of new technologies in general as described in the dimension knowing as empowerment to act, for some people, the willingness to know is caused by an attitude of openness towards the unknown and the desire to open new scenarios that could activate new opportunities for research as well as for themselves. This perspective highly reflects the currently dominant societal goal of health prevention and the main health policy discourse and practice of precaution. People have different perceptions of WGS and its imaginable integration into our health care system or our daily lives, and various approaches to decision-making regarding the potential use of WGS could be observed.

There are suboptimal national resources, inadequate specimen sampling strategies, to optimize epidemiological and clinical inference. There is a gap in the meta-data to interpret SC2-WGS information and other genomic sequencing (Gut microbiome, Genome Wide Sequencing for Prenatal Detection, Tuberculosis Metagenomic sequencing, Nutrigenetics and Cancer Next Generation Sequencing) in a complete and rapid manner. This understanding gap can undermine broad-scale government and public support as a routine part of the pandemic response, especially in low- and middle-income countries.

Therefore an intervention is needed in the form of genomic sequencing education. Before the intervention stage, there will be taking survey data which will be collected using the themes from the FGD results and will focus on assessing public perceptions regarding SC2-WGS and other genomic sequencing. These themes will be formulated into short statements and answered by respondents using a Likert scale. The survey will involve 100-200 respondents via WhatsApp chat bot. Subjects will be asked to express their reactions to short statements on a 4-point Likert scale. The subject will also be asked to express his emotional reaction to the statement with a series of binary questions related to positive or negative feelings. The survey results will be analyzed quantitatively to see the total score and distribution of each statement.

The next stage in this research is to develop social media and communication media. At this stage we will formulate public messages and strategies to improve perceptions based on the survey results. The public message formulated will be useful for educating the public using various social media platforms.

The intervention stage will be carried out by distributing information regarding genome sequencing via bots. After the intervention is carried out, changes in perception will be assessed before and after the intervention through pre-test and post-test questionnaires

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia
        • Contact:
          • Rina Agustina
          • Phone Number: 0213912477
        • Principal Investigator:
          • Rina Agustina, MD, PhD
        • Principal Investigator:
          • Anuraj H Shankar, PhD
        • Sub-Investigator:
          • Erfi Prafiantini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Living or working in Jakarta
  • Young adult
  • Adult
  • Elderly
  • Health workers
  • Public Policy

Exclusion Criteria:

- Living or working outside Jakarta

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Behavioral Education
Educational material is provided via WhatsApp chatbot. After being educated, respondents were given a test to determine the increase in understanding of the material.
Behavioral: Education
Educational material brochures will be given to 800 respondents. Educational material is provided via WhatsApp chatbot. After being educated, respondents were given a test to determine the increase in understanding of the material.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knowledge
Time Frame: 2 months
Assessment of respondents' knowledge regarding the educational material provided, calculated based on the number of questions answered correctly.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oxford University Clinical Research Unit

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rina Agustina, https://imeri.fk.ui.ac.id

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WGS Project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knowledge, Attitudes, Practice

Clinical Trials on Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings