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

Recruiting

• Conditions: Doxycycline STI PEP

• Registration Number: NCT06242730
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2024-01-09
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall incidence of bacterial STIs	From enrolment until the date of first event, assessed up to 96 weeks	Overall incidence of bacterial STIs (including syphilis, CT, NG and MG)
Overall prevalence of bacterial STIs	From enrolment to end of study, i.e. up to 96 weeks	Overall period prevalence of bacterial STIs (including syphilis, CT, NG and MG)
STI period prevalence by individual infectious agent	From enrolment to end of study, i.e. up to 96 weeks	STI period prevalence by individual infectious agent (syphilis, CT, NG; and MG if it is included in the local multiplex PCR panel)
STI incidence by individual infectious agent	From enrolment until the date of first event, assessed up to 96 weeks	STI incidence by individual infectious agent (syphilis, CT, NG; and MG if it is included in the local multiplex PCR panel)

Secondary Outcome Measures

Name	Time	Method
Acceptance of the intervention	From enrolment assessed up to 96 weeks	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
Safety and adherence	From enrolment assessed up to 96 weeks	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)
Microbiome of the urethra and the rectum	From enrolment assessed up to 96 weeks	Genotypic resistance testing for STIs either by whole genome sequencing or "SureSelect" approach performed at every SHCS visit (i.e. every six months)
Genotypic resistance testing of STIs	From enrolment assessed up to 96 weeks	Genotypic resistance testing for STIs either by whole genome sequencing or "SureSelect" approach performed at the time of detection of each STI

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland