Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 6
- 主要终点
- Questionnaire
研究概览
简要总结
Despite the implementation of a national strategy to prevent the transmission of the human immunodeficiency virus (HIV) combining prevention campaigns, condom use, early detection of HIV infections and recommendations for treatment as soon as possible, the number of new HIV-infected patients per year in France does not decrease.
New HIV prevention strategies are therefore clearly needed. Since 2009, several studies have shown that tenofovir disoproxil fumarate and emtricitabine (TDF/FTC), an antiretroviral therapy combining two nucleoside reverse transcriptase inhibitors used for the treatment of patients seropositive for HIV, has preventive activity on HIV transmission. These results enabled the TDF/FTC to obtain in France an extension of the marketing authorization in March 2017 for preexposure prophylaxis (PrEP) of HIV transmission among patients at high risk of contamination.
Since the approval, many studies around the world investigate the use of PrEP in routine practice, highlighting its effectiveness in real life. These studies describe the population of patients who benefit from PrEP in order to adapt their multidisciplinary care but also track the transmission of other sexually transmitted infections to prevent their emergence, given the observed decline in condom use. However, these studies are limited to big cities while PrEP is accessible in all territories.
The Rhône-Alpes region is one of the three French regions that has been the most involved in the implementation of PrEP, one year after the FTC/TDF approval in France. Given the geographical position of the investigators, both in province and close to Switzerland, where the FTC/TDF is not authorized for PrEP, and the non-university nature of five of the six involved hospitals, the investigators would like to determine the profile of patients consulting in this region to benefit from PrEP. This analysis will also determine if the population at risk of the "Alpine Arc" region is similar to that observed in the other cohorts in order to adapt patient care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient having initiated or wishing to initiate PrEP according to the recommendations of the French High Authority of Health in the centers involved in the collection of data
- •Patient informed of the study and having indicated his non opposition for the collection of his health data
排除标准
- •Wardship patient
- •Patient under curatorship
- •Patient unable to give his non-opposition to the use of his health data
结局指标
主要结局
Questionnaire
时间窗: one day
Characterisation of people asking for HIV prophylaxis (either implementation or follow-up) : age, gender, past medical history and risk-taking of patients consulting for PrEP
次要结局
- Incidence of HIV infections in PrEP patients and their management(up to 3 years)
- Use of post-exposure treatment(up to 3 years)
- Adherence to PrEP(one month)
- Sexually Transmitted Infections(up to 3 years)
- Tolerance of PrEP(up to 3 years)
- Impact of PrEP on the evolution of risky sexual behavior(4 weeks)
- Impact of PrEP in HIV and hepatitis screening(one day)