Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 425
- 试验地点
- 19
- 主要终点
- HIV Ab+ (human immunodeficiency virus) antibody
研究概览
简要总结
Title Reaching out to the UNdiagnosed people infected with blood-borne viral infections (RUNtoBBV) Objectives 1. To study the efficacy of an outreach methodology to increase the uptake for screening, linkage to care and treatment in (active or former) people who use drugs (PWUD) Trial design Prospective multicenter interventional cohort design Number of subjects 336 inclusions (with prevalence of HCV Ab: 30%)
- 168 Antwerp
- 168 Limburg
Selection criteria Inclusion criteria:
- 18 years of age
- History of/ or active drug use
- Written informed consent obtained Exclusion criteria
- Currently enrolled in centralized OST program of Free Clinic or CAD Limburg Endpoints The following endpoints will be compared between the centers in Limburg and Antwerp: (Main outcome in bold)
Main objectives:
-
Prevalence of blood-borne viral infections in Belgian (former or active) PWUD:
-
HCV infection (number of HCV Ab+ / number of screened PWUD)
-
HBV infection (number of HBsAg+/number of screened PWUD)
-
HIV infection (number of HIV Ab+/number of screened PWUD)
-
Analysis of linkage to care to hepatologist/ infectiologist (number of patients who adhered to their consultation/number of referred patients)
Secondary objectives:
- Analysis of risk behavior/sociodemographics linked to presence of BBV infections
- Analysis of uptake of anti(retro)viral treatment (number of patients started on treatment/number of patients needing treatment)
- Analysis of treatment adherence (adherence to treatment consultations/total planned consultations)
- Analysis of treatment outcome (total number of cured or virally suppressed patients/total number of treated patients)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •18 years of age
- •History of drug use
- •Active drug use
- •Written informed consent obtained
排除标准
- •Currently enrolled in OST program of Free Clinic or CAD Limburg (centralized OST provision)
结局指标
主要结局
HIV Ab+ (human immunodeficiency virus) antibody
时间窗: day 1
test using whole capillary blood (finger prick testing)
HCV Ab+ (Hepatitis C Virus antibody)
时间窗: day 1
test using whole capillary blood (finger prick testing)
HBsAg+ (Hepatitis B surface Antigen)
时间窗: day 1
test using whole capillary blood (finger prick testing)
次要结局
- Analysis of uptake of anti(retro)viral treatment(Day 1)
- Analysis of treatment adherence(up to one year)
- Analysis of treatment outcome(month 18)
- 4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV)(day 1)
研究者
Geert Robaeys
Principal Investigator
Hasselt University