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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Overall incidence of bacterial STIs
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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)
排除标准
- •Not participating in the SHCS
结局指标
主要结局
Overall incidence of bacterial STIs
时间窗: 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
时间窗: 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 period prevalence by individual infectious agent
时间窗: 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)
STI incidence by individual infectious agent
时间窗: 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)
次要结局
- Acceptance of the intervention(From enrolment assessed up to 96 weeks)
- Safety and adherence(From enrolment assessed up to 96 weeks)
- Microbiome of the urethra and the rectum(From enrolment assessed up to 96 weeks)
- Genotypic resistance testing of STIs(From enrolment assessed up to 96 weeks)