NCT06242730

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

January 9, 2024

Last Update Submit

February 1, 2024

Conditions

Doxycycline STI PEP

Keywords

DocycyclinePostexposure PropylaxisBacterial sexaully tarnsmitted diseasesSexuylly transmitted diseasesPeople living with HIV

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Acceptance of the intervention

    From enrolment assessed up to 96 weeks

  • Safety and adherence

    From enrolment assessed up to 96 weeks

  • Genotypic resistance testing of STIs

    From enrolment assessed up to 96 weeks

  • Microbiome of the urethra and the rectum

    From enrolment assessed up to 96 weeks

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • ≥ 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)

You may not qualify if:

  • Not participating in the SHCS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

STI swabs (urethra, throat, rectal), stool sample

Central Study Contacts

Dominique L Braun, MD

CONTACT

0041442559196dominique.braun@usz.ch

David Wimmersberger, MD

CONTACT

david.wimmersberger@usz.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2024

First Posted

February 5, 2024

Study Start

November 1, 2023

Primary Completion

October 31, 2024

Study Completion

October 31, 2025

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations

CH(1)