Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Facilities "Outside the Walls" Using the Dual Screening Method TROD (Rapid Diagnostic Tests) and FibroScan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Number of RTDs performed compared to the number proposed
研究概览
简要总结
The principle is to propose dedicated monthly screening days bringing together the health personnel involved (hepatologist, addictologist, nurse in charge of the program, addictology nurse and social worker) and to propose appropriate management for each situation assessed.
详细描述
- Information on screening, the days are announced by :
- Mailing to health professionals in the Haute-Vienne Department,
- Announcement to the different professional orders concerned (doctors, pharmacists, midwives, nurses, etc.),
- Flyers and posters in health care facilities,
- Distribution in the AddictLim network newsletter (pharmacists, nurses, social workers members),
- Various: Liaison team, health delegate of the network, intranet site of the hospital, CCAS, AMPA, day care centers.
- Conduct of a SCANVIR day in the non-conventional structure " Hors les murs " :
Each patient presenting during the screening day will have an individualized welcome.
Addictological and hepatological data will be collected throughout the process by the various workers on the individual Scanvir form (attached).
- The patient accepts one or more of the examinations proposed as part of the routine care. After information, he/she does not object to the collection of his/her personal data.
- One or more TRODs and a FibroScan® are performed by the nurse in charge of the care pathway and/or the facility.
- Performing, by the biologist or the authorized person, the delocalized PCR in case of positive HCV TROD
- Consultation with the hepatologist, who gives the results of the TROD and FibroScan® in a closed and dedicated place where the confidentiality of exchanges is guaranteed.
- A written document with the results of the TROD and FibroScan® and GeneXpert is given to the patient.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult 18 and over
- •Patient frequenting an unconventional structure "outside the walls" or referred by a professional in the care sector
- •Patient who agreed to participate to the research
排除标准
- •Patient doesn't agree to participate to the research
结局指标
主要结局
Number of RTDs performed compared to the number proposed
时间窗: up to 10 years
Evaluate the acceptability of simultaneous screening for viral hepatitis B, C and HIV among drug users in non-conventional structures using a dual method by RTDs and FibroScan®
Number of FibroScan® performed compared to the number proposed
时间窗: up to 10 years
Evaluate the acceptability of simultaneous screening for viral hepatitis B, C and HIV among drug users in non-conventional structures using a dual method by RTDs and FibroScan®
次要结局
- Therapeutic compliance with anti-HCV treatments and sustained virological response rate in treated patients,(up to 10 years)
- The absolute number and proportion of patients treated or not maintained in the care pathway in treated patients(up to 10 years)
- Number of days actually completed and the number of participants per session(up to 10 years)
- Number and proportion of patients having accepted the immediate consultation with the hepatologist and/or with an addictologist(up to 10 years)
- Number of patients who had social care(up to 10 years)
- Number of anti-viral B vaccinations offered and carried out(up to 10 years)
- The number and proportion of HCV or HBV antiviral treatments initiated in patients screened positive and having a therapeutic indication(up to 10 years)
- Number of GeneXperts performed compared to the number proposed(up to 10 years)