Clinical trial NCT06242730: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Doxycycline STI PEP
Keywords: Docycycline
Postexposure Propylaxis
Bacterial sexaully tarnsmitted diseases
Sexuylly transmitted diseases
People living with HIV
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss HIV Cohort Study
First posted: 2024-02-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall incidence of bacterial STIs
timeFrame: From enrolment until the date of first event, assessed up to 96 weeks
measure: Overall prevalence of bacterial STIs
timeFrame: From enrolment to end of study, i.e. up to 96 weeks
measure: STI incidence by individual infectious agent
timeFrame: From enrolment until the date of first event, assessed up to 96 weeks
measure: STI period prevalence by individual infectious agent
timeFrame: From enrolment to end of study, i.e. up to 96 weeks
Secondary outcomes:
measure: Acceptance of the intervention
timeFrame: From enrolment assessed up to 96 weeks
measure: Safety and adherence
timeFrame: From enrolment assessed up to 96 weeks
measure: Genotypic resistance testing of STIs
timeFrame: From enrolment assessed up to 96 weeks
measure: Microbiome of the urethra and the rectum
timeFrame: From enrolment assessed up to 96 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References: