Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-20 @ 1:20 PM
Study NCT ID:
NCT07236268
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2025-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of HIV and Sexually Transmitted Infections in Migrant Communities in Slovakia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV, syphilis, hepatitis B, hepatitis C reactivity rates', 'timeFrame': 'From enrolment to 9 months after enrolment', 'description': 'Reactive result on rapid screening'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STI rapid screening', 'HIV screening', 'Hepatitis C screening', 'Syphilis screening', 'Hepatitis B screening'], 'conditions': ['STIs', 'HIV', 'Rapid Detection']}, 'descriptionModule': {'briefSummary': 'Before project launch, key materials were prepared, including informed consents, posters, informational leaflets, patient cards, social media posts, standard operating procedures, patient management plans and patient registries. Necessary medical supplies (rapid tests for HIV, syphilis, hepatitis B and C, lancets, sterile pads, gloves and personal protective equipment) were secured.\n\nThe main field activity took place at the Health Care Centre for Ukrainian refugees in Bratislava (Rovniankova 1), operated by EQUITA and the Bratislava Administrative Region. The screening offer was promoted through posters, leaflets distributed to patients, and social media channels (Facebook, Instagram, Telegram). Testing was provided during regular operating hours to all patients.\n\nA psychologist was available throughout the project to support patients with reactive results, help arrange appointments for laboratory confirmation and specialist care, and accompany patients if requested. Confirmatory diagnostics and treatment pathways were pre-arranged with University Hospital Bratislava (Dermatovenerology Clinic for syphilis; Infectious Diseases Clinic for HIV and viral hepatitis).\n\nRapid testing using capillary blood was conducted. Participants signed informed consent before testing. Four drops of finger-prick blood were applied to rapid test plates, with results available after 10 minutes. Patient IDs, anonymized codes and results were recorded. Regardless of results, all patients received basic counselling on the screened diseases and prevention. In reactive cases, patients were informed immediately, referred for confirmation, and provided psychological support. Confirmed patients received clinical evaluation and treatment covered by state health insurance. Medical and administrative supplies at the facility were replenished weekly.\n\nA second field activity, "Health Day," was implemented at the Assistance Centre on Bottova Street, operated by the Municipality of Bratislava. Partners included the Regional Public Health Authority, the Bratislava Association of Medical Students and SCORA, and EQUITA. The event was promoted through posters and social media. Participants were offered rapid testing for HIV, syphilis, hepatitis B and C, as well as basic cardiovascular screening and stool tests for occult bleeding. Informational brochures, condoms, menstrual aids and patient cards were distributed.', 'detailedDescription': 'Before launching the project, all required materials were prepared, including informed consents, posters, informational leaflets, patient cards, social media posts, standard operating procedures, patient management plans and registries. Medical supplies (rapid tests for HIV, syphilis, hepatitis B and C, lancets, sterile pads, gloves and PPE) were secured.\n\nThe main field activity took place at the Health Care Centre for Ukrainian refugees in Bratislava (Rovniankova 1), operated by EQUITA and the Bratislava Administrative Region. Screening was promoted through posters in waiting areas, printed leaflets, and social media (Facebook, Instagram, Telegram). Testing was provided during regular operating hours to any patient. A psychologist was present to support reactive cases and assist with referral and follow-up. Prior agreements ensured laboratory confirmation and specialist care at University Hospital Bratislava (Dermatovenerology for syphilis; Infectious Diseases Clinic for HIV, hepatitis B and C).\n\nRapid screening using capillary finger-prick blood was conducted. After informed consent, four blood drops were applied to rapid tests, with results available in 10 minutes. Patient identifiers, anonymized codes and results were recorded. All patients received basic prevention counselling. Reactive patients were immediately informed, referred for confirmatory testing, and guided to specialist care; therapy was covered by state health insurance. Supplies at the Centre were replenished weekly.\n\nA second field activity, "Health Day," was implemented at the Assistance Centre on Bottova Street in cooperation with multiple partners. The event offered rapid testing for HIV, syphilis, hepatitis B and C, basic cardiovascular screening, and colorectal cancer stool tests. Informational materials, condoms and menstrual aids were distributed, and participants received patient cards documenting results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ukrainian war refugees residing temporarily in Bratislava region, 18 years and older, that after signing the informed consent underwent rapid screening test for HIV, syphilis, hepatitis B and C. All participants with reactive results were offered consultation with a psychologist and were referred to specialist for laboratory diagnosis and treatment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ukrainian war refugees residing temporarily in Bratislava region, 18 years and older, signing the informed consent\n\nExclusion Criteria:\n\n* non Ukrainian war refugees, age less than 18 years, not signing the informed consent'}, 'identificationModule': {'nctId': 'NCT07236268', 'briefTitle': 'Prevalence of HIV and Sexually Transmitted Infections in Migrant Communities in Slovakia', 'organization': {'class': 'OTHER', 'fullName': 'Comenius University'}, 'officialTitle': 'Prevalence of HIV and Sexually Transmitted Infections in Migrant Communities in Slovakia With a Special Emphasis on Refugees From Ukraine', 'orgStudyIdInfo': {'id': '2023/1338156-0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 - volunteers at outpatient healthcare facility', 'description': 'Patients coming to visit general practitioner or gynaecologist (at outpatient healthcare facility serving Ukrainian war refugees residing temporarily in Bratislava region) who underwent voluntary free-of-charge screening for HIV, syphilis, hepatitis B and C by rapid test based on a capillary blood drop from a fingerpick.'}, {'label': 'Group 2 - volunteers at health screening event', 'description': 'Persons participating at community health screening one day event for Ukrainian war refugees residing temporarily in Bratislava region.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81108', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Comenius University, Faculty of Medicine in Bratislava', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], 'overallOfficials': [{'name': 'Alexandra Bražinová, prof. MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Comenius University, Faculty of Medicine, Institute of Epidemiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Comenius University', 'class': 'OTHER'}, 'collaborators': [{'name': 'World Health Organization', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of Institute of Epidemiology, Faculty of Medicine', 'investigatorFullName': 'Alexandra Brazinova', 'investigatorAffiliation': 'Comenius University'}}}}