STIsNCT07236268
Prevalence of HIV and Sexually Transmitted Infections in Migrant Communities in Slovakia
An observational study of STIs and HIV, run by Comenius University at 1 site in Slovakia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- STIs, HIV, Rapid Detection
- How many people
- 660 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Mar 2023to 30 Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Ukrainian war refugees residing temporarily in Bratislava region
- 18 years and older
- signed the informed consent
Who cannot join
- non Ukrainian war refugees
- age less than 18 years
- not signing the informed consent
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Comenius University, Faculty of Medicine in Bratislava
Bratislava, 81108
About this study
Official title: Prevalence of HIV and Sexually Transmitted Infections in Migrant Communities in Slovakia With a Special Emphasis on Refugees From Ukraine
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.
The 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.
Read more
A 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).
Rapid 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.
A 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.
Read the detailed description
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.
The 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).
Rapid 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.
A 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.
- Conditions
- STIs, HIV, Rapid Detection
- Keywords
- STI rapid screening, HIV screening, Hepatitis C screening, Syphilis screening, Hepatitis B screening
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - volunteers at outpatient healthcare facility | 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. | |
| Group 2 - volunteers at health screening event | Persons participating at community health screening one day event for Ukrainian war refugees residing temporarily in Bratislava region. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV, syphilis, hepatitis B, hepatitis C reactivity rates
Reactive result on rapid screening
Measured: From enrolment to 9 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Mar 2023
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STIsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Alexandra Brazinova, Comenius University
- Investigators
- Alexandra Bražinová, prof. MD, PhD, Principal investigator, Comenius University, Faculty of Medicine, Institute of Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236268
- Sponsor's protocol ID
- 2023/1338156-0
- Other IDs
- 2023
- Status last verified
- Feb 2026
- First submitted
- 15 Nov 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of HIV and Sexually Transmitted Infections in Migrant Communities in Slovakia With a Special Emphasis on Refugees From Ukraine
- ClinicalTrials.gov ID
- NCT07236268
- Acronym / sponsor ID
- 2023/1338156-0
- Conditions
- STIs, HIV, Rapid Detection
- Keywords
- STI rapid screening, HIV screening, Hepatitis C screening, Syphilis screening, Hepatitis B screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Nov 2025 (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.
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.
The 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.
A 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).
Rapid 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.
A 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.
Detailed description
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.
The 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).
Rapid 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.
A 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - volunteers at outpatient healthcare facility | – | –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. |
| Group 2 - volunteers at health screening event | – | –Persons participating at community health screening one day event for Ukrainian war refugees residing temporarily in Bratislava region. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Ukrainian war refugees residing temporarily in Bratislava region
- 18 years and older
- signed the informed consent
Key exclusion criteria (3 listed)
- non Ukrainian war refugees
- age less than 18 years
- not signing the informed consent
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
HIV, syphilis, hepatitis B, hepatitis C reactivity rates
Time frame: From enrolment to 9 months after enrolment
Reactive result on rapid screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Alexandra Bražinová, prof. MD, PhD principal investigator
Comenius University, Faculty of Medicine, Institute of Epidemiology
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 STIs and HIV, run by Comenius University at 1 site in Slovakia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 18 Feb 2026. 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 Slovakia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV, syphilis, hepatitis B, hepatitis C reactivity rates (time frame: From enrolment to 9 months after enrolment). 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 18 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.