NCT02971488

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
529

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 13, 2019

Completed
Last Updated

September 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

October 13, 2016

Results QC Date

May 12, 2019

Last Update Submit

August 9, 2019

Conditions

Hepatitis CDrug UsersHarm ReductionHIV

Keywords

Hepatitis CPWIDLinkage-to-care

Outcome Measures

Primary Outcomes (4)

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

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

    2 years

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

    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).

    2 years

  • Percentage of Participants Who Started HCV Antiviral Therapy.

    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).

    2 years

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

    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).

    2 years

Secondary Outcomes (2)

  • Percentage of Participants With Active HCV in Screened Population

    2 years

  • Prevalence of Other Chronic Viral Infections in the Population Screened

    2 years

Study Arms (1)

Persons who inject drugs (PWID)

The study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed.

Other: Screening for HCV in PWID and Linkage-To-Care

Interventions

Screening for HCV in PWID and Linkage-To-CareOTHER

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.

Persons who inject drugs (PWID)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed. It is estimated that between 4000 and 6000 people per day visit the shantytown for their dose. The regional government's Anti-Drug Agency has a mobile HRU operating daily in the area. The unit provides screening tests to anyone who is willing to take them, regardless of whether they are already aware of their serological status or not. Screening includes education on prevention of HCV infection and other transmissible diseases.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Samples were collected in DBS and sent to National Centre of Microbiology

MeSH Terms

Conditions

Hepatitis CDrug MisuseHarm Reduction

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Results Point of Contact

Title
Pablo Ryan
Organization
Hospital Universitario Infanta Leonor
pablo.ryan@salud.madrid.org
0034616832148

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2016

First Posted

November 23, 2016

Study Start

January 15, 2017

Primary Completion

December 31, 2018

Study Completion

May 10, 2019

Last Updated

September 13, 2019

Results First Posted

September 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

not shared in public