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Active, Not Recruiting

NCT Number: NCT07150871

Impact of Covid-19 on Syphilis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients for whom the data required for the study are not available in medical records or electronic filing systems

Treatment and study plan

Patients diagnosed with syphilis

Other

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.

Primary outcomes

  1. Trend of syphilis

    Time frame: Baseline

    Analyze the trend of syphilis before and after the COVID-19 pandemic

Secondary outcomes

  1. Characteristics of affected patients

    Time frame: Baseline

    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.

  2. Interaction between syphilis and HIV

    Time frame: Baseline

    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.

  3. Infection Recurrence Rate

    Time frame: Baseline

    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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Official study title

Impact of the COVID-19 Pandemic on Syphilis: Epidemiological Changes and Interaction With HIV

Acronym: SIPAND

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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