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Completed

NCT Number: NCT04363411

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

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)

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Key information

Conditions

Hepatitis B Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepadnaviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Free Clinic Antwerp, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

finger prick screening for BBV infections and questionnaires by outreaching methodology

Other

Screening by fingerprick for HCV Ab, HBsAg and HIV Ab and a questionnaire will be performed at sites outside of the regular treatment facilities.

Primary outcomes

  1. HCV Ab+ (Hepatitis C Virus antibody)

    Time frame: day 1

    test using whole capillary blood (finger prick testing)

  2. HBsAg+ (Hepatitis B surface Antigen)

    Time frame: day 1

    test using whole capillary blood (finger prick testing)

  3. HIV Ab+ (human immunodeficiency virus) antibody

    Time frame: day 1

    test using whole capillary blood (finger prick testing)

Secondary outcomes

  1. 4. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV)

    Time frame: day 1

    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.

  2. Analysis of uptake of anti(retro)viral treatment

    Time frame: Day 1

    percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment

  3. Analysis of treatment adherence

    Time frame: up to one year

    percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment

  4. Analysis of treatment outcome

    Time frame: month 18

    total number of cured or virally suppressed patients/total number of treated patients

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Ziekenhuis Oost-Limburg

Registry information

Acronym: RUNtoBBV

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2020
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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