SyphilisSIPANDNCT07150871
Impact of Covid-19 on Syphilis
An observational study of Syphilis and COVID - 19, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
Sexually transmitted infections (STIs) represent a significant challenge to global public health. Although many of these infections are treatable, failure to diagnose and delayed treatment can lead to serious complications, including infertility, chronic inflammatory diseases, and an increased risk of HIV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syphilis, COVID - 19, HIV (Human Immunodeficiency Virus)
- What is being tested?
- Patients diagnosed with syphilis
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2025to 28 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥18 years with a microbiological and/or clinical diagnosis of syphilis, treated by the Infectious Diseases Department of the University Hospital of Alessandria from 2017 to 2025
Who may be able to join
- Patients aged ≥18 years
- Patients with microbiological and/or clinical diagnosis of syphilis
- Patients treated by the Infectious Diseases Department of the University Hospital of Alessandria
- Signature of informed consent form
Who cannot join
- Patients for whom the data required for the study are not available in medical records or electronic filing systems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the COVID-19 Pandemic on Syphilis: Epidemiological Changes and Interaction With HIV
Sexually transmitted infections (STIs) represent a significant challenge to global public health. Although many of these infections are treatable, failure to diagnose and delayed treatment can lead to serious complications, including infertility, chronic inflammatory diseases, and an increased risk of HIV transmission. The COVID-19 pandemic has had a significant impact on healthcare management, the economy, and citizens' lifestyles. The first lockdown in the spring of 2020 affected the entire country, while in the following months, government measures were differentiated on a regional basis, with varying restrictions on activities and mobility. Physical distancing, the use of personal protective equipment, fear of contagion, and health restrictions contributed to a delay in STI diagnoses, resulting in an increase in transmission and severity of cases diagnosed after 2022.
Read the detailed description
Syphilis is a chronic infectious disease with a prolonged course, characterized by considerable clinical variability, so much so that it is referred to as the great imitator, due to its ability to manifest itself with symptoms that can mimic numerous other diseases. The clinical picture develops through alternating phases of activity, with obvious symptomatic manifestations, and latency, in which the infection remains silent in the body. It is a globally widespread infection, transmitted mainly through sexual contact, although it can also be transmitted congenitally or through direct contact with infected lesions. The relationship between syphilis and HIV is of growing clinical importance due to increasing rates of co-infection and the particular interaction between these two STIs. Syphilis facilitates the transmission and acquisition of HIV, while HIV infection accelerates the natural progression of syphilis. In addition, HIV has been associated with false positive and false negative results in serological tests for syphilis, complicating the diagnosis and management of the disease. A study conducted by the Department of Medicine in Toronto and the Ministry of Health showed that, in individuals with latent syphilis, the prevalence of HIV remained stable between 1991 and 2012, but increased approximately fivefold from 2012 to 2020, reaching a peak of 52.6%. In 2022, the Ministry of Health reported that syphilis cases had doubled compared to 2018, with incidence rising from 2.5 to 4.3 cases per 100,000 inhabitants. Gonorrhea increased from 1.5 to 3.3 cases per 100,000 inhabitants during the same period. Chlamydia, although less documented than in other European countries, also showed an upward trend, with 1,396 cases per 100,000 inhabitants in 2022. The COVID-19 pandemic has had a significant impact on healthcare management, the economy, and citizens' lifestyles. The first lockdown in the spring of 2020 affected the entire country, while in the following months, government measures were differentiated on a regional basis, with varying restrictions on activities and mobility. Physical distancing, the use of personal protective equipment, fear of contagion, and health restrictions contributed to a delay in STI diagnoses, resulting in an increase in transmission and severity of cases diagnosed after 2022. A study published in BMJ Open in 2021 analyzed the impact of the pandemic on healthcare services compared to previous years. The systematic review highlighted a 37% reduction in access to care, with decreases of 42% for outpatient visits, 28% for hospitalizations, 31% for diagnostics, and 30% for therapies. The pandemic has therefore significantly reduced the use of healthcare services, with a greater impact on people with non-serious conditions.
- Being tested
- Patients diagnosed with syphilis
- Medical subject headings
- Syphilis, COVID-19, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients diagnosed with syphilisOther
Collection of clinical data from patients aged ≥18 years with a microbiological and/or clinical diagnosis of syphilis, treated by the Infectious Diseases Department of the University Hospital of Alessandria from 2017 to 2025.
What is being measured
The primary outcome is the main question the study is designed to answer.
Trend of syphilis
Analyze the trend of syphilis before and after the COVID-19 pandemic
Measured: Baseline
Secondary outcomes (3)
Characteristics of affected patients
Describe the characteristics of patients with syphilis referred to the Infectious Diseases Unit of the SS Antonio e Biagio e Cesare Arrigo University Hospital in Alessandria between 2017 and 2025.
Measured: Baseline
Interaction between syphilis and HIV
Examine the interaction between syphilis and HIV in a post-pandemic context, identifying how the pandemic has affected co-infection between syphilis and HIV, monitoring any changes in co-infection rates.
Measured: Baseline
Infection Recurrence Rate
Evaluate the infection recurrence rate, calculated by taking the date of recovery from the original infection as the baseline and the onset of the same infection as the event of interest
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start28 May 2025
- Primary completion16 Jun 2025
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150871
- Sponsor's protocol ID
- ASO.Minf.25.01
- Acronym
- SIPAND
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 2 Sep 2025
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the COVID-19 Pandemic on Syphilis: Epidemiological Changes and Interaction With HIV
- ClinicalTrials.gov ID
- NCT07150871
- Acronym / sponsor ID
- SIPAND / ASO.Minf.25.01
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 2 Sep 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.
Sexually transmitted infections (STIs) represent a significant challenge to global public health. Although many of these infections are treatable, failure to diagnose and delayed treatment can lead to serious complications, including infertility, chronic inflammatory diseases, and an increased risk of HIV transmission. The COVID-19 pandemic has had a significant impact on healthcare management, the economy, and citizens' lifestyles. The first lockdown in the spring of 2020 affected the entire country, while in the following months, government measures were differentiated on a regional basis, with varying restrictions on activities and mobility. Physical distancing, the use of personal protective equipment, fear of contagion, and health restrictions contributed to a delay in STI diagnoses, resulting in an increase in transmission and severity of cases diagnosed after 2022.
Detailed description
Syphilis is a chronic infectious disease with a prolonged course, characterized by considerable clinical variability, so much so that it is referred to as the great imitator, due to its ability to manifest itself with symptoms that can mimic numerous other diseases. The clinical picture develops through alternating phases of activity, with obvious symptomatic manifestations, and latency, in which the infection remains silent in the body. It is a globally widespread infection, transmitted mainly through sexual contact, although it can also be transmitted congenitally or through direct contact with infected lesions. The relationship between syphilis and HIV is of growing clinical importance due to increasing rates of co-infection and the particular interaction between these two STIs. Syphilis facilitates the transmission and acquisition of HIV, while HIV infection accelerates the natural progression of syphilis. In addition, HIV has been associated with false positive and false negative results in serological tests for syphilis, complicating the diagnosis and management of the disease. A study conducted by the Department of Medicine in Toronto and the Ministry of Health showed that, in individuals with latent syphilis, the prevalence of HIV remained stable between 1991 and 2012, but increased approximately fivefold from 2012 to 2020, reaching a peak of 52.6%. In 2022, the Ministry of Health reported that syphilis cases had doubled compared to 2018, with incidence rising from 2.5 to 4.3 cases per 100,000 inhabitants. Gonorrhea increased from 1.5 to 3.3 cases per 100,000 inhabitants during the same period. Chlamydia, although less documented than in other European countries, also showed an upward trend, with 1,396 cases per 100,000 inhabitants in 2022. The COVID-19 pandemic has had a significant impact on healthcare management, the economy, and citizens' lifestyles. The first lockdown in the spring of 2020 affected the entire country, while in the following months, government measures were differentiated on a regional basis, with varying restrictions on activities and mobility. Physical distancing, the use of personal protective equipment, fear of contagion, and health restrictions contributed to a delay in STI diagnoses, resulting in an increase in transmission and severity of cases diagnosed after 2022. A study published in BMJ Open in 2021 analyzed the impact of the pandemic on healthcare services compared to previous years. The systematic review highlighted a 37% reduction in access to care, with decreases of 42% for outpatient visits, 28% for hospitalizations, 31% for diagnostics, and 30% for therapies. The pandemic has therefore significantly reduced the use of healthcare services, with a greater impact on people with non-serious conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years with a microbiological and/or clinical diagnosis of syphilis, treated by the Infectious Diseases Department of the University Hospital of Alessandria from 2017 to 2025
Key inclusion criteria (4 listed)
- Patients aged ≥18 years
- Patients with microbiological and/or clinical diagnosis of syphilis
- Patients treated by the Infectious Diseases Department of the University Hospital of Alessandria
- Signature of informed consent form
Key exclusion criteria (1 listed)
- Patients for whom the data required for the study are not available in medical records or electronic filing systems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients diagnosed with syphilisCollection of clinical data from patients aged ≥18 years with a microbiological and/or clinical diagnosis of syphilis, treated by the Infectious Diseases Department of the University Hospital of Alessandria from 2017 to 2025. | Other | – |
Primary outcome
Trend of syphilis
Time frame: Baseline
Analyze the trend of syphilis before and after the COVID-19 pandemic
3 secondary outcomes
Characteristics of affected patients
Time frame: Baseline
Interaction between syphilis and HIV
Time frame: Baseline
Infection Recurrence Rate
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Syphilis and COVID - 19, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Trend of syphilis (time frame: Baseline). 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 2 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.