2025-524823-34-00招募中3 期
Doxycycline post-exposure prophylaxis: Weekly versus event-driven Intake for STI prevention among MSM and TGW taking PrEP (Doxy-WISE study)
Institute Of Tropical Medicine1 个研究点 分布在 1 个国家目标入组 556 人开始时间: 2026年5月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- Incidence rate ratio of NG, CT, and TP infections in the W-DoxyPEP vs ED-DoxyPEP arms
研究概览
简要总结
Assess if Weekly-DoxyPEP is non-inferior to Event-Driven-DoxyPEP in terms of the incidence rate of Neisseria gonorrhoeae (NG)/ Chlamydia trachomatis (CT) and Treponema pallidum (TP) infections among MSM and TGW taking HIV-PrEP in Belgium
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide informed consent in Dutch or English and adhere to the study procedures
- •Aged 18 years or older
- •Assigned male sex at birth
- •Identifying as gay, bisexual or other men who have sex with men or transgender women
- •Enrolled in PrEP care
- •Being HIV negative
- •Reporting having had condomless anal sex with at least one non-steady partner in the preceding year
排除标准
- •Hypersensitivity to doxycycline or any substance used in the IMP
- •Concomitant use of medication interacting with doxycycline
- •Any contra-indication to the use of doxycycline, as mentioned in the summary of product characteristics
研究组 & 干预措施
Doxycycline Sandoz 100 mg tabletten, Doxycycline EG 200 mg Tabletten
Test
干预措施: Doxycycline Sandoz 100 mg tabletten (Drug)
Doxycycline Sandoz 100 mg tabletten, Doxycycline EG 200 mg Tabletten
Test
干预措施: Doxycycline EG 200 mg Tabletten (Drug)
结局指标
主要结局
Incidence rate ratio of NG, CT, and TP infections in the W-DoxyPEP vs ED-DoxyPEP arms
Incidence rate ratio of NG, CT, and TP infections in the W-DoxyPEP vs ED-DoxyPEP arms
次要结局
- Rate ratio of tetracyclines, macrolides, cephalosporins, and penicillins in the W-DoxyPEP vs ED-DoxyPEP arms
- MIC distribution (doxycycline/cefixime/ciprofloxacin) of commensal Neisseria spp., oral streptococci and E. coli in the W-DoxyPEP vs ED-DoxyPEP arms
- Incidence rate ratio of symptomatic NG infections in the W-DoxyPEP vs ED-DoxyPEP arms
- Incidence rate ratio of symptomatic CT infections in the W-DoxyPEP vs ED-DoxyPEP arms
- Incidence rate ratio of symptomatic TP infections in the W-DoxyPEP vs ED-DoxyPEP arms
- Incidence rate ratio of all NG infections in the W-DoxyPEP vs ED-DoxyPEP arms
- Incidence rate ratio of all CT infections in the W-DoxyPEP vs ED-DoxyPEP arms
- Incidence rate ratio of all TP infections in the W-DoxyPEP vs ED-DoxyPEP arms
- Tetracycline MIC distribution of NG isolates in the W-DoxyPEP vs ED-DoxyPEP arms
- participants' perception/experience, preference, and acceptability in using doxyPEP
- Cost of integrating W-DoxyPEP vs ED-DoxyPEP in routine HIV-PrEP follow-up, if the strategy is proved to be effective, incremental cost per STI avoided/Quality of life Adjusted Life Years (QALY) gained
研究者
Chris Kenyon
Scientific
Institute Of Tropical Medicine
研究点 (1)
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