Doxi-Rio: Pilot Implementation of Post-exposure Prophylaxis for Sexually Transmitted Infections With Doxycycline in Rio de Janeiro, Brazil
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of bacterial sexually transmitted infections (STIs)
研究概览
简要总结
The goal of this clinical trial is to learn if doxycycline post-exposure prophylaxis (doxy-PEP) can help prevent bacterial sexually transmitted infections (STIs) among sexual and gender minorities in Rio de Janeiro, Brazil, including men who have sex with men, transgender women, and travestis who are living with HIV or using HIV pre-exposure prophylaxis (PrEP). Bacterial STIs such as syphilis, gonorrhea, and chlamydia remain common in these populations, even with existing prevention strategies.
This study aims to answer the following questions: whether doxy-PEP can reduce the number of new STIs, whether it is safe and well tolerated, whether participants use it as recommended, and whether its use may contribute to antibiotic resistance or changes in the body's natural bacteria. Doxy-PEP involves taking a dose of doxycycline, an antibiotic, shortly after sexual activity to reduce the risk of acquiring STIs.
Participants will first receive information and counseling about doxy-PEP, including its possible benefits and risks, and will then choose whether or not to use this prevention strategy. Those who choose to use doxy-PEP will take doxycycline after sex as instructed and will be followed for up to 48 weeks, with clinic visits approximately every three months. During these visits, participants will be tested for STIs, monitored for side effects, and asked about medication use, sexual health, and overall well-being.
Researchers will collect information on new STI diagnoses, safety, and how consistently participants use doxy-PEP. The study will also explore participants' experiences and perceptions of this strategy. The results of this study will help determine whether doxy-PEP is a practical and acceptable approach for STI prevention in Brazil and may inform future public health strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals assigned male at birth (cisgender or transgender men), transgender women, or travestis who have sex with men
- •Age ≥18 years
- •Living with HIV or currently using HIV pre-exposure prophylaxis (PrEP) for at least 6 months
- •History of at least one bacterial sexually transmitted infection (chlamydia, gonorrhea, or syphilis) in the past 12 months (laboratory-confirmed or self-reported)
- •Willing and able to provide informed consent
排除标准
- •Known allergy or hypersensitivity to doxycycline or other tetracycline-class antibiotics
- •Current use of medications that may significantly interact with doxycycline or are contraindicated, including systemic retinoids, barbiturates, carbamazepine, or phenytoin
结局指标
主要结局
Incidence of bacterial sexually transmitted infections (STIs)
时间窗: Up to 48 weeks
Cumulative incidence of laboratory-confirmed symptomatic and asymptomatic bacterial STIs (syphilis, gonorrhea, and chlamydia).
次要结局
- Uptake of doxy-PEP(At enrollment)
- Adverse events(From enrollment to 48 weeks)
- Adherence to doxy-PEP(Up to 48 weeks)
- Incidence of symptomatic and asymptomatic bacterial STIs(Up to 48 weeks.)
- Incidence of specific STIs (chlamydia, gonorrhea, and syphilis)(Up to 48 weeks)
- Antimicrobial resistance in Neisseria gonorrhoeae(Baseline and up to 48 weeks)
- Colonization with antimicrobial-resistant bacteria(Baseline and week 48)
- Acceptability of doxy-PEP(Up to 48 weeks)