Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-02 @ 12:10 AM
Study NCT ID:
NCT05188456
Status:
UNKNOWN
Last Update Posted:
2023-04-24
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact Evaluation of the COVID-19 Prevention on Risk Factors of HIV and Sexually Transmitted Comorbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-07', 'releaseDate': '2023-08-10'}, {'resetDate': '2024-09-12', 'releaseDate': '2024-04-18'}, {'resetDate': '2025-08-11', 'releaseDate': '2025-07-25'}, {'resetDate': '2025-09-05', 'releaseDate': '2025-08-18'}], 'estimatedResultsFirstSubmitDate': '2023-08-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 prevention knowledge', 'timeFrame': 'Through study completion, an average of one and half year', 'description': 'The questionnaire of COVID-19 prevention knowledge will be used to measure the knowledge level.'}, {'measure': 'COVID-19 prevention intention and anxiety', 'timeFrame': 'Through study completion, an average of one and half year', 'description': 'The questionnaire of COVID-19 prevention intention and anxiety will be used to measure the attitude level.'}, {'measure': 'COVID-19 prevention behavior', 'timeFrame': 'Through study completion, an average of one and half year', 'description': 'The questionnaire of COVID-19 prevention behavior will be used to measure the behavior level.'}, {'measure': 'Stigma', 'timeFrame': 'Through study completion, an average of one and half year', 'description': 'The questionnaire of stigma will be used to measure the stigma level of HIV infected people.'}, {'measure': 'HIV risk factor and behavior', 'timeFrame': 'Through study completion, an average of one and half year', 'description': 'The questionnaire of HIV risk factor and behavior will be used to measure the risk condition during COVID-19 era.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Attitude', 'Behavior', 'Coronavirus disease 19 (COVID-19)', 'HIV high risk group', 'Knowledge', 'People living with HIV/AIDS (PLWHA)', 'Protection Motivation Theory (PMT)', 'Stigma'], 'conditions': ['COVID-19 Pandemics', 'Human Immunodeficiency Virus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Two study populations will be incruited in this research:\n\n1. Those who had been diagnosed with HIV/AIDS.\n2. Those who self-idenftified as HIV high risk group, such as having unsafe sex experience or injecting drug user.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for HIV/AIDS participants:\n\n1. Participants who diagnosed with HIV/AIDS.\n2. Age over 18 years old.\n3. Participants who can read and communicate.\n\nExclusion Criteria for HIV/AIDS participants:\n\n1\\. Participants who can't read and communicate.\n\nInclusion Criteria for HIV high risk group:\n\n1. 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.\n2. Injecting Drug User(IDU)\n3. Age over 18 years old.\n4. Participants who can read and communicate.\n\nExclusion Criteria for HIV high risk group:\n\n1\\. Participants who can't read and communicate."}, 'identificationModule': {'nctId': 'NCT05188456', 'briefTitle': 'The Impact Evaluation of the COVID-19 Prevention on Risk Factors of HIV and Sexually Transmitted Comorbidity', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '202012HM041'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'PIAO-YI CHIOU, doctoral', 'role': 'CONTACT', 'email': 'piaoyi@ntu.edu.tw', 'phone': '+886-2-23123456', 'phoneExt': '88427'}], 'facility': 'School of Nursing of National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'PIAO-YI CHIOU, doctoral', 'role': 'CONTACT', 'email': 'piaoyi@ntu.edu.tw', 'phone': '+886-2-23123456', 'phoneExt': '88427'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Piao-Yi Chiou', 'investigatorAffiliation': 'National Taiwan University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-08-10', 'type': 'RELEASE'}, {'date': '2024-03-07', 'type': 'RESET'}, {'date': '2024-04-18', 'type': 'RELEASE'}, {'date': '2024-09-12', 'type': 'RESET'}, {'date': '2025-07-25', 'type': 'RELEASE'}, {'date': '2025-08-11', 'type': 'RESET'}, {'date': '2025-08-18', 'type': 'RELEASE'}, {'date': '2025-09-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Piao-Yi Chiou, Associate Professor, National Taiwan University'}}}}