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)

University of Zurich (UZH)

Status: Enrolling

Conditions: Doxycycline STI PEP

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT06242730

BASEC-Nr. 2023-01057

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

People living with HIV participating in the Swiss HIV Cohort Study on doxycycline STI PEP

Description:

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