Doxycycline Prophylaxis or Incentive Payments to Reduce Incident Syphilis Among HIV- Infected Men Who Have Sex With Men Who Continue to Engage in High Risk Sex: A Randomized, Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Measure changes in the incidence of Syphilis, Gonorrhea and Chlamydia at 12 weeks, 24 weeks, 26 weeks and 48 weeks in the Doxycycline Arm and Contingency Management Arms
研究概览
简要总结
This pilot study will investigate the feasibility of conducting a large, randomized trial comparing a structural intervention to contingency management to reduce incident syphilis infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free. The investigators will : 1) measure adherence to study visits in both arms; 2) measure adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study participants and 4) to the extent possible in a small pilot study of short duration, compare effectiveness of doxycycline with that of a monetary incentive for remaining STI free.
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
- 是
入选标准
- •HIV-infected MSM or transgender women who have sex with men
- •At least two documented and adequately treated episodes of syphilis since HIV diagnosis
排除标准
- •Had a known allergy or intolerance to doxycycline
- •Abused alcohol or other substances which in the opinion of the investigators would jeopardize adherence to study procedures
研究组 & 干预措施
Doxycycline
Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.
干预措施: Doxycycyline (Drug)
Incentive
Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.
干预措施: Incentive (Behavioral)
结局指标
主要结局
Measure changes in the incidence of Syphilis, Gonorrhea and Chlamydia at 12 weeks, 24 weeks, 26 weeks and 48 weeks in the Doxycycline Arm and Contingency Management Arms
时间窗: 12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks
次要结局
- Measure adherence to study visits in the Doxycycline and Contingency Management Arms at Weeks 12, 24, 36 and 48(12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks)
- Measure adherence to daily Doxycycline Use using Blood Samples in the Doxycycline Arm at Weeks 12, 24 and 36(12 Weeks, 24 Weeks and 36 Weeks)
- Measure changes in self-report sexual risk behaviors (e.g., condom use, drug use and number of partners) in the Doxycycline and Contingency Management Arms at Weeks 12, 24 and 36(12 Weeks, 24 Weeks and 36 Weeks)
研究者
Matthew Beymer
Epidemiologist, Health and Mental Health Services
Los Angeles LGBT Center