- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05188456
The Impact Evaluation of the COVID-19 Prevention on Risk Factors of HIV and Sexually Transmitted Comorbidity
April 20, 2023 updated by: Piao-Yi Chiou, National Taiwan University
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
2200
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
- Name: PIAO-YI CHIOU, doctoral
- Phone Number: 88427 +886-2-23123456
- Email: piaoyi@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- School of Nursing of National Taiwan University
-
Contact:
- PIAO-YI CHIOU, doctoral
- Phone Number: 88427 +886-2-23123456
- Email: piaoyi@ntu.edu.tw
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Two study populations will be incruited in this research:
- Those who had been diagnosed with HIV/AIDS.
- Those who self-idenftified as HIV high risk group, such as having unsafe sex experience or injecting drug user.
Description
Inclusion Criteria for HIV/AIDS participants:
- Participants who diagnosed with HIV/AIDS.
- Age over 18 years old.
- Participants who can read and communicate.
Exclusion Criteria for HIV/AIDS participants:
1. Participants who can't read and communicate.
Inclusion Criteria for HIV high risk group:
- 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.
Exclusion Criteria for HIV high risk group:
1. Participants who can't read and communicate.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, an average of one and half year
|
|
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.
|
Through study completion, an average of one and half year
|
|
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.
|
Through study completion, an average of one and half year
|
|
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.
|
Through study completion, an average of one and half year
|
|
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.
|
Through study completion, an average of one and half year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
January 13, 2022
Primary Completion (Anticipated)
June 30, 2023
Study Completion (Anticipated)
July 31, 2023
Study Registration Dates
First Submitted
January 10, 2022
First Submitted That Met QC Criteria
January 11, 2022
First Posted (Actual)
January 12, 2022
Study Record Updates
Last Update Posted (Actual)
April 24, 2023
Last Update Submitted That Met QC Criteria
April 20, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Slow Virus Diseases
- HIV Infections
- COVID-19
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 202012HM041
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.
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