Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections

Study Overview
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Brief Summary
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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)

Official Title
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Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections

Conditions
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Hepatitis B, Hepatitis c, Human Immunodeficiency Virus

Intervention / Treatment
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* Other: finger prick screening for BBV infections and questionnaires by outreaching methodology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age History of drug use Active drug use Written informed consent obtained Exclusion Criteria: Currently enrolled in OST program of Free Clinic or CAD Limburg (centralized OST provision)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drug use<br> | Other: finger prick screening for BBV infections and questionnaires by outreaching methodology<br>* Screening by fingerprick for HCV Ab, HBsAg and HIV Ab and a questionnaire will be performed at sites outside of the regular treatment facilities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV Ab+ (Hepatitis C Virus antibody) | test using whole capillary blood (finger prick testing) | day 1 | 
| HBsAg+ (Hepatitis B surface Antigen) | test using whole capillary blood (finger prick testing) | day 1 | 
| HIV Ab+ (human immunodeficiency virus) antibody | test using whole capillary blood (finger prick testing) | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV) | i. Combine results from positive finger prick test with questionnaire regarding sociodemographic factors, migration, risk factors for blood born viruses (sexual contacts, incarceration, drug use). The questionaire does not include a score on scale. | day 1 | 
| Analysis of uptake of anti(retro)viral treatment | percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment | Day 1 | 
| Analysis of treatment adherence | percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment | up to one year | 
| Analysis of treatment outcome | total number of cured or virally suppressed patients/total number of treated patients | month 18 |