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临床试验/NCT06188442
NCT06188442进行中(未招募)4 期

Superiority of On-demand Pre-exposure Prophylaxis Versus Post-exposure Prophylaxis on Using Doxycycline for Preventing Sexually Transmitted Infections in Men Who Have Sex With Men

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年3月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
300
试验地点
2
主要终点
Time to the first episode of gonorrhoea after the enrolment visit

研究概览

简要总结

The goal of this clinical trial is to compare the effectiveness of doxycycline taken for on-demand pre-exposure prophylaxis (DoxyODPrEP) and its post-exposure use (DoxyPEP) in preventing bacterial sexually transmitted infections (STI), including chlamydia, gonorrhoea, and syphilis among men who have sex with men (MSM). The main questions it aims to answer are:

  1. Is DoxyODPrEP superior to DoxyPEP?
  2. Are both regimens safe?
  3. Does the MSM community accept the use of doxycycline to prevent bacterial STI?

Participants will be asked to take doxycycline according to the study arm they are randomly assigned to, and attend regular clinical follow-ups during the 2-year observation period. Researchers will compare the bacterial STI incidences between the two groups to see if DoxyODPrEP is superior to DoxyPEP.

详细描述

Participants would be randomly assigned to either DoxyODPrEP or DoxyPEP arm, and be instructed to take doxycycline with the respective dosing schedule. They would be followed up for 24 months for nucleic acid amplification test (NAAT) and antibody tests against bacterial STI, namely chlamydia, gonorrhoea, and syphilis. The subjects and investigators would not be blinded due to its open-label nature, as the two arms' dosing schedules are different. Participants in the DoxyODPrEP arm would be instructed to take two doxycycline hyclate 100mg capsules orally 2-24 hours before sex, and one 100mg capsule each 24 and 48 hours after loading dose. If they have sex within 48 hours after the loading dose, they would be asked to continue a daily 100mg until two days after the last sex. Participants in the DoxyPEP arm would be instructed to take two doxycycline hyclate 100mg capsules orally within 24 hours and up to 72 hours after each sex. At each clinic visit, urine, and pharyngeal and rectal swabs would be self-collected on-site by the participants following instructions. Pill count would be performed for each follow-up visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • has had sex with another male in the past six months
  • normally reside in Hong Kong
  • can communicate in written and spoken Chinese or English
  • willing and able to give written informed consent
  • being willing and able to attend scheduled study clinic visits
  • at risk of STI (had condomless sex with more than one man in the past 12 months, history of STI diagnosis in the past 12 months, inclination to have condomless sex, and other HIV-PrEP-eligible criteria)

排除标准

  • Being allergic to tetracycline class medicines
  • Currently taking medications that are contraindicated with doxycycline
  • Using antibiotics for more than 14 days in the month preceding enrolment

研究组 & 干预措施

DoxyPEP

Active Comparator

Participants in the DoxyPEP arm would be instructed to take two doxycycline hyclate 100mg capsules orally within 24 hours and up to 72 hours after each sex.

干预措施: DoxyPEP (Drug)

DoxyODPrEP

Active Comparator

Participants in the DoxyODPrEP arm would be instructed to take two doxycycline hyclate 100mg capsules orally 2-24 hours before sex, and one 100mg capsule each 24 and 48 hours after loading dose. If they have sex within 48 hours after the loading dose, they would be asked to continue a daily 100mg until two days after the last sex.

干预措施: DoxyODPrEP (Drug)

结局指标

主要结局

Time to the first episode of gonorrhoea after the enrolment visit

时间窗: Months 1 to 24

Time to the first episode of gonorrhoea after the enrolment visit

Time to the first episode of syphilis after the enrolment visit

时间窗: Months 1 to 24

Time to the first episode of syphilis after the enrolment visit

Time to the first episode of chlamydia after the enrolment visit

时间窗: Months 1 to 24

Time to the first episode of chlamydia after the enrolment visit

次要结局

  • Safety profile(Months 1 to 24)
  • Acceptability of regimens(Months 1 to 24)
  • Retention(Months 1 to 24)
  • Time to the first episode of HIV after the enrolment visit(Months 1 to 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tsz Ho Kwan

Research Assistant Professor

Chinese University of Hong Kong

研究点 (2)

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