Doxycycline PEP and 4CMenB as a Comprehensive Prevention Strategy in MSM and TGW at High Risk for Bacterial STIs Within the Swiss HIV Cohort Study

University of Zurich400 enrolled

Overview

The study aims at assessing effectiveness of offering event-driven Doxy PEP and 4CMenB immunization in MSM/TGW at high STI risk. It plans to offer this STI prevention package to all MSM/TGW in the SHCS who are at risk of STI and then comparing 12-months STI incidence between those accepting and those not accepting the prevention package. The proposal further hosts two interesting sub-studies: One assessing potential effect of Doxy PEP on the microbiome and the other one assessing potential impact of Doxy PEP on TP, MG and CT resistance.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Doxycycline STI PEP

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: ≥ 18 years of age * Participant in the SHCS * On antiretroviral therapy with suppressed viral load for ≥ 3 months * MSM or TGW * ≥ 1 bacterial STI (syphilis, CT, MG, or NG) within the past 3 years and/or reporting condomless sex with ≥ 1 occasional partner within the last 6 months * Consenting for off-label use of doxycycline as PEP and/or 4CMenB for the prevention of bacterial STIs * No allergy or intolerance to doxycycline or 4CMenB * No other contraindication for doxycycline (e. g. co-medication) Exclusion Criteria: * Not participating in the SHCS

Locations (1)

University Hospital Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Overall incidence of bacterial STIs

Overall incidence of bacterial STIs (including syphilis, CT, NG and MG)

Time frame: From enrolment until the date of first event, assessed up to 96 weeks

Overall prevalence of bacterial STIs

Overall period prevalence of bacterial STIs (including syphilis, CT, NG and MG)

Time frame: From enrolment to end of study, i.e. up to 96 weeks

STI incidence by individual infectious agent

STI incidence by individual infectious agent (syphilis, CT, NG; and MG if it is included in the local multiplex PCR panel)

Time frame: From enrolment until the date of first event, assessed up to 96 weeks

STI period prevalence by individual infectious agent

STI period prevalence by individual infectious agent (syphilis, CT, NG; and MG if it is included in the local multiplex PCR panel)

Time frame: From enrolment to end of study, i.e. up to 96 weeks

Secondary Outcomes

Acceptance of the intervention

Web-based online questionnaire on acceptance of the intervention implemented in the SHCS DJANGO tool assessed once for every participant during the whole study period

Time frame: From enrolment assessed up to 96 weeks

Safety and adherence

Web-based online questionnaire on safety and adherence of the intervention implemented in the SHCS DJANGO tool, assessed at every SHCS visit (i.e. every six months)

Time frame: From enrolment assessed up to 96 weeks

Genotypic resistance testing of STIs

Genotypic resistance testing for STIs either by whole genome sequencing or "SureSelect" approach performed at the time of detection of each STI

Time frame: From enrolment assessed up to 96 weeks

Microbiome of the urethra and the rectum

Genotypic resistance testing for STIs either by whole genome sequencing or "SureSelect" approach performed at every SHCS visit (i.e. every six months)

Time frame: From enrolment assessed up to 96 weeks

Doxycycline PEP and 4CMenB as a Comprehensive Prevention Strategy in MSM and TGW at High Risk for Bacterial STIs Within the Swiss HIV Cohort Study

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts