Knowledge, Attitudes, PracticeNCT06441981
Public Perception and Policy for SARS-CoV-2 Whole Genome Sequencing and Genomics for All
A study testing Education in people with Knowledge, Attitudes, Practice, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living or working in Jakarta
- Young adult
- Adult
- Elderly
- Health workers
- Public Policy
Who cannot join
- Living or working outside Jakarta
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Rina Agustina, 0213912477
Rina Agustina, MD, PhD
About this study
Official title: 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.
Read the 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
- Conditions
- Knowledge, Attitudes, Practice
- Being tested
- Education
- Keywords
- Genome Sequencing, Public Perception, Public Policy, COVID-19
- Medical subject headings
- Behavior, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Education | Other | Educational material is provided via WhatsApp chatbot. After being educated, respondents were given a test to determine the increase in understanding of the material. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
Assessment of respondents' knowledge regarding the educational material provided, calculated based on the number of questions answered correctly.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Oct 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The questionnaire in whatsapp chatbot format will be given to 100 and up to 200 persons from each targeted population. There Four targeted population namely, The public overall (comprised mostly of 18-29 years old adults whom have the most cases), Vulnerable groups (including the elderly between 50-80 years old, parents of children 0-12 years, and pregnant women), Doctors and other frontline health workers, and Program implementers and policy makers.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Clinical Research Unit
- Responsible party
- Principal investigator, Rina Agustina, Universitas Indonesia
- Investigators
- Rina Agustina, Principal investigator, https://imeri.fk.ui.ac.id
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441981
- Sponsor's protocol ID
- WGS Project
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schumann S, Gschmeidler B, Pellegrini G. Knowing, relationships and trust-citizens' perceptions of whole genome sequencing for the Genetics Clinic of the Future. J Community Genet. 2021 Jan;12(1):67-80. doi: 10.1007/s12687-020-00486-0. Epub 2020 Sep 30.
PubMed 32997319Lewis KL, Han PK, Hooker GW, Klein WM, Biesecker LG, Biesecker BB. Characterizing Participants in the ClinSeq Genome Sequencing Cohort as Early Adopters of a New Health Technology. PLoS One. 2015 Jul 17;10(7):e0132690. doi: 10.1371/journal.pone.0132690. eCollection 2015.
PubMed 26186621
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closing the Gap in Public Perception and Policy for SARS-CoV-2 Whole Genome Sequencing and Genomics for All
- ClinicalTrials.gov ID
- NCT06441981
- Acronym / sponsor ID
- WGS Project
- Conditions
- Knowledge, Attitudes, Practice
- Keywords
- Genome Sequencing, Public Perception, Public Policy, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Oxford University Clinical Research Unit
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The questionnaire in whatsapp chatbot format will be given to 100 and up to 200 persons from each targeted population. There Four targeted population namely, The public overall (comprised mostly of 18-29 years old adults whom have the most cases), Vulnerable groups (including the elderly between 50-80 years old, parents of children 0-12 years, and pregnant women), Doctors and other frontline health workers, and Program implementers and policy makers.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Education | Other | Behavioral: EducationEducational material is provided via WhatsApp chatbot. After being educated, respondents were given a test to determine the increase in understanding of the material. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Living or working in Jakarta
- Young adult
- Adult
- Elderly
- Health workers
Key exclusion criteria (1 listed)
- Living or working outside Jakarta
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationEducational 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. | Behavioural | Behavioral Education |
Primary outcome
Knowledge
Time frame: 2 months
Assessment of respondents' knowledge regarding the educational material provided, calculated based on the number of questions answered correctly.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 32997319Schumann S, Gschmeidler B, Pellegrini G. Knowing, relationships and trust-citizens' perceptions of whole genome sequencing for the Genetics Clinic of the Future. J Community Genet. 2021 Jan;12(1):67-80. doi: 10.1007/s12687-020-00486-0. Epub 2020 Sep 30.
- Background: PubMed 26186621Lewis KL, Han PK, Hooker GW, Klein WM, Biesecker LG, Biesecker BB. Characterizing Participants in the ClinSeq Genome Sequencing Cohort as Early Adopters of a New Health Technology. PLoS One. 2015 Jul 17;10(7):e0132690. doi: 10.1371/journal.pone.0132690. eCollection 2015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rina Agustina principal investigator
https://imeri.fk.ui.ac.id
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Knowledge, Attitudes, Practice, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rina Agustina (+622129189160 ext. 201052, r.agustina@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06441981, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.