The Impact Evaluation of the COVID-19 Prevention on Risk Factors of HIV and Sexually Transmitted Comorbidity

Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188456
• Other study ID #: 202012HM041
• Status: Recruiting
• Start date: January 13, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2023
• Source: National Taiwan University
• Contact: PIAO-YI CHIOU, doctoral
• Phone: +886-2-23123456
• Email: piaoyi[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for HIV/AIDS participants:

1. Participants who diagnosed with HIV/AIDS.

2. Age over 18 years old.

3. 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:

1. 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.

2. Injecting Drug User(IDU)

3. Age over 18 years old.

4. Participants who can read and communicate.

Exclusion Criteria for HIV high risk group:

1. Participants who can't read and communicate.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• COVID-19
• COVID-19 Pandemics
• HIV Infections
• Human Immunodeficiency Virus

Locations

Country	Name	City	State
Taiwan	School of Nursing of National Taiwan University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 prevention knowledge	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
Primary	COVID-19 prevention intention and anxiety	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
Primary	COVID-19 prevention behavior	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
Primary	Stigma	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
Primary	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.	Through study completion, an average of one and half year