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 (DOXY-MEN)

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 Overview

• Status: Recruiting
• Conditions: Doxycycline STI PEP

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Dominique L Braun, MD; Phone Number: 0041442559196; Email: dominique.braun@usz.ch
• Study Contact Backup: Name: David Wimmersberger, MD; Email: david.wimmersberger@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zürich
    • Contact: Dominique L Braun, MD; Phone Number: +41442559196; Email: dominique.braun@usz.ch
    • Contact: David Wimmersberger, MD; Email: david.wimmersberger@usz.ch
    • Principal Investigator: David Wimmersberger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population for this study are MSM or TGW at high risk for a bacterial STI (≥1 occasional partners within the preceding 6 months).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
People living with HIV participating in the Swiss HIV Cohort Study on doxycycline STI PEP; The target population for this study are MSM or TGW at high risk for a bacterial STI (≥1 occasional partners within the preceding 6 months) taking teh doxycycline STI PEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall incidence of bacterial STIs	Overall incidence of bacterial STIs (including syphilis, CT, NG and MG)	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)	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)	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)	From enrolment to end of study, i.e. up to 96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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	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)	From enrolment assessed up to 96 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Swiss HIV Cohort Study

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Estimated): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: People living with HIV; Docycycline; Postexposure Propylaxis; Bacterial sexaully tarnsmitted diseases; Sexuylly transmitted diseases
• Other Study ID Numbers: BASEC-Nr. 2023-01057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No