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OpenTrials
Completed

NCT Number: NCT02971488

The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID

Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. More frequent diagnosis, new methods that prevent loss of tracking, and access to antiviral treatment are all strategies that must be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.

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Key information

Conditions

Hepatitis C Behavior Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Drug Misuse Drug Users Flaviviridae Infections HIV Harm Reduction Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • PWID
  • >18 years of age
  • Signed consent form

Exclusion criteria

Treatment and study plan

Screening for HCV in PWID and Linkage-To-Care

Other

Screening, diagnosis and treatment of HCV in PWID, will be part of a harm reduction strategy.

Treatment of HCV infected PWID will be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population.

Primary outcomes

  1. Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to

    Time frame: 2 years

    Percentage of participants who had a positive HCV test and results of the test was delivered to them.

  2. Percentage of Participants Who Were Evaluated at a HCV Clinic.

    Time frame: 2 years

    Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).

  3. Percentage of Participants Who Started HCV Antiviral Therapy.

    Time frame: 2 years

    Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).

  4. Percentage of Participants Who Achieved a Sustained Virological Response (SVR)

    Time frame: 2 years

    Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).

Secondary outcomes

  1. Percentage of Participants With Active HCV in Screened Population

    Time frame: 2 years

    Screening for HCV using dried blood samples on WhatmanTM cards in subjects from Cañada Real based on the results of the laboratory tests performed in phase I. The percentage of active HCV infections will be calculated from the total population of active drug addicts screened.

  2. Prevalence of Other Chronic Viral Infections in the Population Screened

    Time frame: 2 years

    Other viruses (HIV, HBV, HDV) using dried blood samples on WhatmanTM cards in subjects from Cañada Real based will be analysed. The prevalence of these infections will be calculated base on the total screened population.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Infanta Leonor

Other

Collaborators

  • Fundacion SEIMC-GESIDA
  • Instituto de Salud Carlos III

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 23, 2016
Registry last updated
Sep 13, 2019

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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