NCT07397403招募中4 期
The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing Sexually Transmitted Diseases (Gonorrhea, Chlamydia, Syphilis) Among Men Who Have Sex With Men in Bangkok, Thailand.
Bangrak STIs Center1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年10月6日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of doxycycline in preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) among men who have sex with men in Thailand.
研究概览
简要总结
The objective of this research is to evaluate the efficacy and safety of doxycycline in MSM for preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) in Thailand
Participation in this study will last approximately 12 weeks and will include 2-3 clinic visits, along with 10-11 follow-up phone contacts over a period of 11 weeks.
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
盲法说明
Labotatory staffs
入排标准
- 年龄范围
- 18 Days 至 60 Days（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Biological male, aged not over 60 years
- •Thai nationality
- •Able to read, communicate, and understand the Thai language
- •Men who have sex with men (MSM), aged 18 years or older and not over 60 years
- •Having at least one of the following risk factors:
- •A history of condomless sex, or condom failure (breakage, leakage, or slippage), via any sexual route with at least two sexual partners within the past 3 months
- •A diagnosis of gonorrhea, chlamydia, or syphilis within the past 6 months
- •Current use of HIV pre-exposure prophylaxis (PrEP)
- •Willing and able to participate in study procedures (e.g., able to return to the clinic for scheduled testing for gonorrhea, chlamydia, and syphilis; able to complete doxycycline use records; and able to receive follow-up phone calls from the research team)
- •Willing and able to provide written informed consent to participate in the study
排除标准
- •History of allergy to tetracycline-class antibiotics
- •Diagnosed with syphilis and not yet treated, or currently receiving treatment with benzathine penicillin G or doxycycline
- •Receipt of benzathine penicillin G within the past 12 weeks
- •Prior receipt of a gonorrhea vaccine
- •Current use of medications or products that may interact with doxycycline, including:
- •Vitamin A derivatives (e.g., isotretinoin, acitretin)
- •Antiepileptic drugs (e.g., phenytoin, carbamazepine, phenobarbital)
- •Immunosuppressive agents (e.g., methotrexate)
- •Medications for heart failure or cardiac arrhythmias (e.g., digoxin)
- •Anticoagulants (e.g., warfarin)
- •Use of oral or injectable medications that affect blood cells, such as anticancer drugs, chemotherapy, systemic corticosteroids, or targeted therapies
- •History of renal impairment (eGFR < 60 mL/min/1.73 m²) or hepatic impairment (AST or ALT > 3 times the upper limit of normal)
- •Uncontrolled or unstable underlying diseases, such as hematologic disorders, cancer, autoimmune diseases, or neurological disorders
- •Severe medical or psychiatric conditions that, in the investigator's judgment, may increase study-related risk or impair the participant's ability to provide informed consent
- •Alcohol dependence (inability to control alcohol consumption, withdrawal symptoms upon reduction or cessation, or continued use despite harm) or illicit drug dependence (regular, uncontrolled use) within the past 12 months prior to enrollment, which may affect doxycycline use for STI prevention
- •Previous participation in this study with prior randomization
研究组 & 干预措施
DoxyPEP arm
Experimental
Participants will receive DoxyPEP for STIs prophylaxis in this arm
干预措施: Doxycycline (200mg/day) (Drug)
Control arm
No Intervention
Participants will receive standard STIs prevention
结局指标
主要结局
To evaluate the efficacy of doxycycline in preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) among men who have sex with men in Thailand.
时间窗: 12 weeks
Measure the proportion of participants who test positive by NAAT for gonorrhea or chlamydia at any anatomical site (genital, pharyngeal, or rectal), or who are diagnosed with syphilis during the study period.
次要结局
未报告次要终点
研究者
Rossaphorn Kittiyaowamarn
Chief of Bangrak STIs Center
Bangrak STIs Center
研究点 (1)
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