COVID-19 PandemicsNCT05188456
The Impact Evaluation of the COVID-19 Prevention on Risk Factors of HIV and Sexually Transmitted Comorbidity
An observational study of COVID-19 Pandemics and Human Immunodeficiency Virus, run by National Taiwan University at 1 site in Taiwan.
Trial summary
This is a cross-sectional research. The Protection Motivation Theory (PMT) was applied as theoretical framework to analyze correlation of prevention knowledge, prevention intentions and anxiety, and prevention behavior of COVID-19 and HIV risk feature and behavior and stigma of people living with HIV/AIDS (PLWHA), and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemics, Human Immunodeficiency Virus
- How many people
- 2,200 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jan 2022to 31 Jul 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two study populations will be incruited in this research: 1. Those who had been diagnosed with HIV/AIDS. 2. Those who self-idenftified as HIV high risk group, such as having unsafe sex experience or injecting drug user.
Who may be able to join
- Participants who diagnosed with HIV/AIDS.
- Age over 18 years old.
- Participants who can read and communicate.
- Participants who have experienced unsafe sex, regardless of their gender orientation, such as those who describe themselves as men who have sex with men (MSM), heterosexuals, transgender, sex workers, etc.
- Injecting Drug User(IDU)
- Age over 18 years old.
- Participants who can read and communicate.
Who cannot join
- 1. Participants who can't read and communicate.
- 1. Participants who can't read and communicate.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
School of Nursing of National Taiwan University
Taipei, 100
PIAO-YI CHIOU, doctoral, +886-2-23123456 ext. 88427, piaoyi@ntu.edu.tw
About this study
Official title: The Impact Evaluation of the COVID-19 Prevention Knowledge, Attitude, and Practice on Risk Factors of HIV and Sexually Transmitted Comorbidity: Application of Protection Motivation Theory
This is a cross-sectional research. The Protection Motivation Theory (PMT) was applied as theoretical framework to analyze correlation of prevention knowledge, prevention intentions and anxiety, and prevention behavior of COVID-19 and HIV risk feature and behavior and stigma of people living with HIV/AIDS (PLWHA), and HIV high-risk groups. Purposive and snowball sampling will be applied to recruit participant who visit hospital, HIV/AIDS related institutions, and social media platforms. The investigators expect that the outcome could reveal the relationship of cognition and attitude of COVID-19 to HIV prevention and treatment.
Read the detailed description
The prevention strategies can effectively block the spread of Coronavirus disease (Coronavirus disease 19; COVID-19), and at the same time may indirectly reduce or increase the risk behaviors and factors of Human Immunodeficiency Virus (HIV) and sexually transmitted comorbidities. The main purpose of this research is to apply the Protection Motivation Theory (PMT) as the framework to analyze COVID-19 prevention knowledge, COVID-19 prevention intentions and anxiety level, and COVID-19 prevention behavior and HIV risk behavior and risk factors of people living with HIV/AIDS (PLWHA) and HIV high-risk groups. The cross-sectional research method was adopted, and the subjects included the northern, central, southern, and eastern regions of Taiwan.About 1100 PLWHA and 1100 high-risk groups will be recruited. The information of recruitment will be disseminated through the AIDS designated medical institutions and related institutions, and social media, Snowball recruitment of interviewees will also be used. After completing the online questionnaire, the structural equation modeling (SEM) will be applied to test the good of fit of the theory model and to explain the structural relationship between COVID-19 prevention knowledge, attitudes, behaviors and HIV risk factors. The relationship with the above variables and stigma also been discussed. In addition to verifying the theories proposition of PMT, the research results also contribute to the prevention and treatment of HIV high-risk groups, and provide important references for prevention strategies for susceptible groups during the epidemic of emerging infectious diseases in the future.
- Conditions
- COVID-19 Pandemics, Human Immunodeficiency Virus
- Keywords
- Attitude, Behavior, Coronavirus disease 19 (COVID-19), HIV high risk group, Knowledge, People living with HIV/AIDS (PLWHA), Protection Motivation Theory (PMT), Stigma
- Medical subject headings
- COVID-19, Acquired Immunodeficiency Syndrome, Behavior, Social Stigma
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 prevention knowledge
The questionnaire of COVID-19 prevention knowledge will be used to measure the knowledge level.
Measured: Through study completion, an average of one and half year
COVID-19 prevention intention and anxiety
The questionnaire of COVID-19 prevention intention and anxiety will be used to measure the attitude level.
Measured: Through study completion, an average of one and half year
COVID-19 prevention behavior
The questionnaire of COVID-19 prevention behavior will be used to measure the behavior level.
Measured: Through study completion, an average of one and half year
Stigma
The questionnaire of stigma will be used to measure the stigma level of HIV infected people.
Measured: Through study completion, an average of one and half year
HIV risk factor and behavior
The questionnaire of HIV risk factor and behavior will be used to measure the risk condition during COVID-19 era.
Measured: Through study completion, an average of one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start13 Jan 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Piao-Yi Chiou, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188456
- Sponsor's protocol ID
- 202012HM041
- Status last verified
- Apr 2023
- First submitted
- 10 Jan 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Evaluation of the COVID-19 Prevention Knowledge, Attitude, and Practice on Risk Factors of HIV and Sexually Transmitted Comorbidity: Application of Protection Motivation Theory
- ClinicalTrials.gov ID
- NCT05188456
- Acronym / sponsor ID
- 202012HM041
- Conditions
- COVID-19 Pandemics, Human Immunodeficiency Virus
- Keywords
- Attitude, Behavior, Coronavirus disease 19 (COVID-19), HIV high risk group, Knowledge, People living with HIV/AIDS (PLWHA), Protection Motivation Theory (PMT), Stigma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 12 Jan 2022 (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.
This is a cross-sectional research. The Protection Motivation Theory (PMT) was applied as theoretical framework to analyze correlation of prevention knowledge, prevention intentions and anxiety, and prevention behavior of COVID-19 and HIV risk feature and behavior and stigma of people living with HIV/AIDS (PLWHA), and HIV high-risk groups. Purposive and snowball sampling will be applied to recruit participant who visit hospital, HIV/AIDS related institutions, and social media platforms. The investigators expect that the outcome could reveal the relationship of cognition and attitude of COVID-19 to HIV prevention and treatment.
Detailed description
The prevention strategies can effectively block the spread of Coronavirus disease (Coronavirus disease 19; COVID-19), and at the same time may indirectly reduce or increase the risk behaviors and factors of Human Immunodeficiency Virus (HIV) and sexually transmitted comorbidities. The main purpose of this research is to apply the Protection Motivation Theory (PMT) as the framework to analyze COVID-19 prevention knowledge, COVID-19 prevention intentions and anxiety level, and COVID-19 prevention behavior and HIV risk behavior and risk factors of people living with HIV/AIDS (PLWHA) and HIV high-risk groups. The cross-sectional research method was adopted, and the subjects included the northern, central, southern, and eastern regions of Taiwan.About 1100 PLWHA and 1100 high-risk groups will be recruited. The information of recruitment will be disseminated through the AIDS designated medical institutions and related institutions, and social media, Snowball recruitment of interviewees will also be used. After completing the online questionnaire, the structural equation modeling (SEM) will be applied to test the good of fit of the theory model and to explain the structural relationship between COVID-19 prevention knowledge, attitudes, behaviors and HIV risk factors. The relationship with the above variables and stigma also been discussed. In addition to verifying the theories proposition of PMT, the research results also contribute to the prevention and treatment of HIV high-risk groups, and provide important references for prevention strategies for susceptible groups during the epidemic of emerging infectious diseases in the future.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two study populations will be incruited in this research: 1. Those who had been diagnosed with HIV/AIDS. 2. Those who self-idenftified as HIV high risk group, such as having unsafe sex experience or injecting drug user.
Key inclusion criteria (7 listed)
- Participants who diagnosed with HIV/AIDS.
- Age over 18 years old.
- Participants who can read and communicate.
- Participants who have experienced unsafe sex, regardless of their gender orientation, such as those who describe themselves as men who have sex with men (MSM), heterosexuals, transgender, sex workers, etc.
- Injecting Drug User(IDU)
Key exclusion criteria (2 listed)
- 1. Participants who can't read and communicate.
- 1. Participants who can't read and communicate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COVID-19 prevention knowledge
Time frame: Through study completion, an average of one and half year
The questionnaire of COVID-19 prevention knowledge will be used to measure the knowledge level.
COVID-19 prevention intention and anxiety
Time frame: Through study completion, an average of one and half year
The questionnaire of COVID-19 prevention intention and anxiety will be used to measure the attitude level.
COVID-19 prevention behavior
Time frame: Through study completion, an average of one and half year
The questionnaire of COVID-19 prevention behavior will be used to measure the behavior level.
Stigma
Time frame: Through study completion, an average of one and half year
The questionnaire of stigma will be used to measure the stigma level of HIV infected people.
HIV risk factor and behavior
Time frame: Through study completion, an average of one and half year
The questionnaire of HIV risk factor and behavior will be used to measure the risk condition during COVID-19 era.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemics and Human Immunodeficiency Virus, run by National Taiwan University at 1 site in Taiwan.
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 7 inclusion and 2 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 24 Apr 2023. 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 Taiwan. 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 PIAO-YI CHIOU, doctoral (+886-2-23123456 ext. 88427, piaoyi@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 prevention knowledge (time frame: Through study completion, an average of one and half year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.