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

NCT ID: NCT06242730

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Doxycycline STI PEP

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss HIV Cohort Study

NETWORK

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dominique L Braun, MD

Role: CONTACT

0041442559196

David Wimmersberger, MD

Role: CONTACT

Facility Contacts

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Dominique L Braun, MD

Role: primary

+41442559196

David Wimmersberger, MD

Role: backup

Other Identifiers

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BASEC-Nr. 2023-01057

Identifier Type: -

Identifier Source: org_study_id

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