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Summary

Therefore, despite numerous studies, the clinical and laboratory signs of syphilis, changes in the syphilis morbidity structure among HIV-infected patients, as well as the impact of medical and social factors on the development of concurrent syphilis and HIV infection are open to discussion, mostly due to clear inter-temporal changes. A deeper review of the problem of the concurrent infection and data update is required, also in the Russian Federation where growing prevalence of HIV infection has been steadily recorded in the recent years with a high incidence of syphilis. So, this research aims at solving these tasks.

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A total of 686 hospital records were selected during the study. The patients were split into three observation groups (Tables 2.1.2 and 2.1.3): the main one and the first and second comparison groups.

Table 2.1.2 – Comparison Groups (by Gender and Age).

The main observation group consisted of 272 in-patients with syphilis concurrent with HIV infection who were treated at SPb SBHCI City DV Clinic from 2018 through 2020.

The first comparison group consisted of 139 in-patients with syphilis and HIV infection who were treated at SPb SBHCI City DV Clinic from 2008 through 2010. Patients in the main group and the first comparison group were selected through nonrepeated sampling and processing of the patients’ hospital records.

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ampicillin) for the patients subject to the test of cure in their neighbourhood clinics. All selected patients received ART. Patients in both groups were distributed by the diagnosis of syphilis as follows (Table 2.1.4): Patients were evenly distributed by the diagnosis of syphilis across the comparison groups.

Table 2.1.4 – Patients in Three Observation Groups by Form of Syphilis

Study enrolment criteria:

3.Clinical and laboratory evidence of syphilis in patients with a history of confirmed HIV infection

4.Clinical and laboratory evidence of syphilis in patients with HIV infection newly diagnosed while on in-patient treatment at SPb SBHCI City DV Clinic

Additional enrolment criteria for therapy efficacy evaluation:

4.Patients with early forms of syphilis

5.Patients’ visits for test of cure (after the end of the main period of treatment)

6.Patients on ART

Study exclusion criteria:

4.Pregnant women hospitalised for preventive therapy

5.Patients with equivocal syphilis and/or HIV serological test results

6.Patients with seroresistance

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the ratio of syphilis forms between the patients from the main group and the patients from the first comparison group was compared.

2.2.2. Assessment of Risk Factors for Concurrent Infection

In order to assess risk factors for concurrent syphilis and HIV infection, epidemiological, medical and social characteristics were studied (age structure, gender breakdown, marital status, education, employment, use of alcohol, substances, and specific features of sexual behaviour). The analysis was based on the methodology guidelines, Analysis of the Epidemiological Situation with HIV Infection and Comorbid Conditions, 2017. The probability of an outcome and its correlation with present risk factors was assessed using the odds ratio (OR) method.

A questionnaire for an anonymous survey (Appendix А) was developed based on the Social Adaptation Self-Evaluation Scale (SASS) [35] and Psychometric Sexual Behaviour Evaluation Scale [47]. The questionnaire had 23 items that could be split into two groups. Questionnaire items helped to obtain comprehensive understanding of the patients’ social status, including their employment, education, marital status, relations with their friends and family, and criminal record. The second part of the questionnaire evaluated the patients’ behaviour, including risky sexual behaviour, age of sexual debut, homosexual relations, availability of a permanent partner, number of partners, experience of group contacts and unprotected sex, use of pre-exposure prophylaxis (PrEP) for HIV, and impact of addictions (alcohol or substances) on their lifestyle and sexual behaviour.

2.2.3. Evaluation of Clinical and Laboratory Data

In order to evaluate the clinical and laboratory data in the study groups, the patients’ clinical status and laboratory test results for all forms of syphilis were compared (Table 2.2.2).

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The laboratory tests of CSF taken from the patients undergoing cerebrospinal puncture during in-patient treatment included microprecipitation test (MPT); enzymelinked immunoassay (ELISA) with a cutoff index (IgМCOI; IgGCOI, titre; IgM+IgG); immunofluorescence test with whole CSF (IFAw), passive hemagglutination assay (PHA), and CSF assay for protein, glucose and cytosis. All these tests were done at the specialised laboratory at SPb SBHCI City DV Clinic.

Syphilis was diagnosed based on the patient’s clinical status and laboratory test results.

For the purpose of blood serum tests, national tests systems were primarily used: SyphilisAGKLMRP and ECOLAB (Russia) for MPT, LuisRPGAtest and NiarMedicPlus (Russia) for PHA and Recombi-Best-antipalladium and Vektor-Best (Russia) for ELISA.

Registration and performance of laboratory serological tests were based on Order of the Ministry of Healthcare of the Russian Federation No. 87 dated 26 March 2011 On Improvement of Serological Diagnosis of Syphilis.

In order to confirm the syphilitic lesions of different organs and systems, patients were examined by medical specialists (ophthalmologist, otolaryngologist, neuropathologist, and general internist) in accordance with Order of the Ministry of Healthcare of the Russian Federation No. 924n dated 15 November 2012 On Approval of the Procedure for Dermatovenerology Medical Care of the Population.

In order to diagnose the syphilitic lesions in the nervous system, CSF samples were examined serologically and clinically.

Abnormal CSF results included cytosis of over five cells per mm3 and protein above 0.45 g/L (in accordance with the clinical recommendations of the Russian Society of Dermatovenerologists and Cosmetologists, 2008 to 2020).

Serological tests with CSF were done using national test systems: SyphilisAGKLMRP and ECOLAB (Russia) for MPT, LuisRPGAtest and NiarMedicPlus (Russia) for PHA, Recombi-Best-antipalladium and VEKTOR-BEST (Russia) for ELISA, and LUMIBEST-antipalladium and VEKTOR-BEST (Russia) for IFAw. The registration and performance of laboratory serological CSF tests were based on the Order of the