NCT05415930尚未招募不适用
Evaluation of an Adaptative, Multidisciplinary, Reach-out Program, Facilitating Pre Exposition
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba0 个研究点目标入组 100 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Primary endpoint is the healthcare retention rate over the 96 weeks study.
研究概览
简要总结
Evaluation of an adaptative, multidisciplinary, reach-out program, facilitating pre exposition HIV prophylaxis (PrEP) prescription and retention in care, in a group of trans womens (TW) at high risk of HIV infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Trans woman ≥ 18 years old; Negative HIV-1 and HIV-2 serology; Participant on PrEP or request to start PrEP or reporting present, past or future exposure to HIV; Participant agreed with the constraints imposed by the study (every 3 months visits); Non opposition.
排除标准
- •Subject with positive HIV serology; Subject with clinical signs suggesting a primary HIV infection; Subjects planning to travel/live abroad for more than 3 consecutive months or planning to live outside Ile-de-France region; Creatinine clearance < 60 mL/min (Cockroft's formula); History of chronic kidney disease, osteoporosis, osteopenia; Subject receiving a potentially nephrotoxic treatment (long-term nonsteroidal anti-inflammatory drugs); Ongoing post-exposure antiretroviral therapy (the participant may be tested 6 weeks after the end of treatment); Treatment under investigation; Chronic gastrointestinal illness (or chronic nausea or vomiting) interfering with intestinal absorption; HBs antigen positive or with an isolated anti-HBc antibody if participant is not ready to take continuous PrEP; Life-threatening illness (cancer) or other serious illness (cardiovascular, renal, pulmonary, unstable diabetes) which would require treatment that could interfere with treatment adherence; Hypersensitivity to one of the components of TDF / FTC.
结局指标
主要结局
Primary endpoint is the healthcare retention rate over the 96 weeks study.
时间窗: 96 weeks
Primary endpoint is the healthcare retention rate over the first 48 weeks study.
时间窗: 48 weeks
次要结局
- Epidemiological and clinical data assessment.(Week 96)
- 8. Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.(Week -4)
- Precariousness score from W-4 to W96(Week 96)
- 2. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W96.(Weeks 96)
- 3. PrEP adherence questionnaire at W-4(Week- 4)
- 3. PrEP adherence questionnaire at Week 96(Week 96)
- Questionnaire to explore PrEP barriers, difficulties and expectations of study participants from W-4 to W96.(Week 96)
- 3. PrEP adherence questionnaire at Week 4(Week 4)
- Number of HIV seroconversion from D1 to W96.(Week 96)
- Incidence of sexually transmitted infections from D1 to W96.participants(week 96)
- 3. PrEP adherence questionnaire at Week 12(Week 12)
- 3. PrEP adherence questionnaire at Week 48(Week 48)
- Incidence of clinical and laboratory adverse events or those leading to discontinuation of PrEP from W4 to W96.(Week 96)
- Multi modal intervention compliance from D1 to W96(Week 96)
- 1. Total number of TW followed-up for PrEP in the Infectious Diseases Department of Bichat Hospital at W48(Weeks 48)
- 3. PrEP adherence questionnaire at Week 24(Week 24)
- Concomitant treatment (including hormonal therapy) from W-4 to W96.(Week 96)
- Satisfaction questionnaire from D1 to W96(Week 96)
- Global quality of life questionnaire from W-4 to W96.(Week 96)
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