Doxycycline STI PEP
Conditions
Keywords
Docycycline, Postexposure Propylaxis, Bacterial sexaully tarnsmitted diseases, Sexuylly transmitted diseases, People living with HIV
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.
Interventions
None listed
Sponsors
Swiss HIV Cohort Study
University of Zurich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| STI period prevalence by individual infectious agent | From enrolment to end of study, i.e. up to 96 weeks | STI period prevalence by individual infectious agent (syphilis, CT, NG; and MG if it is included in the local multiplex PCR panel) |
| Overall incidence of bacterial STIs | From enrolment until the date of first event, assessed up to 96 weeks | Overall incidence of bacterial STIs (including syphilis, CT, NG and MG) |
| Overall prevalence of bacterial STIs | From enrolment to end of study, i.e. up to 96 weeks | Overall period prevalence of bacterial STIs (including syphilis, CT, NG and MG) |
| STI incidence by individual infectious agent | From enrolment until the date of first event, assessed up to 96 weeks | STI incidence by individual infectious agent (syphilis, CT, NG; and MG if it is included in the local multiplex PCR panel) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of the intervention | From enrolment assessed up to 96 weeks | 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 |
| Safety and adherence | From enrolment assessed up to 96 weeks | 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) |
| Genotypic resistance testing of STIs | From enrolment assessed up to 96 weeks | Genotypic resistance testing for STIs either by whole genome sequencing or SureSelect approach performed at the time of detection of each STI |
| Microbiome of the urethra and the rectum | From enrolment assessed up to 96 weeks | Genotypic resistance testing for STIs either by whole genome sequencing or SureSelect approach performed at every SHCS visit (i.e. every six months) |
Countries
Switzerland
Contacts
Primary ContactDominique L Braun, MD
Backup ContactDavid Wimmersberger, MD
Outcome results
None listed