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| Name | Class |
|---|---|
| Swiss HIV Cohort Study | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of the intervention | 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 | From enrolment assessed up to 96 weeks |
| Safety and adherence |
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Inclusion Criteria:
≥ 18 years of age
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique L Braun, MD | Contact | 0041442559196 | dominique.braun@usz.ch | |
| David Wimmersberger, MD | Contact | david.wimmersberger@usz.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Recruiting | Zurich | 8091 | Switzerland |
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STI swabs (urethra, throat, rectal), stool sample
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) |
| From enrolment assessed up to 96 weeks |
| Genotypic resistance testing of STIs | Genotypic resistance testing for STIs either by whole genome sequencing or "SureSelect" approach performed at the time of detection of each STI | From enrolment assessed up to 96 weeks |
| Microbiome of the urethra and the rectum | Genotypic resistance testing for STIs either by whole genome sequencing or "SureSelect" approach performed at every SHCS visit (i.e. every six months) | From enrolment assessed up to 96 weeks |