NCT04035980

Brief Summary

The investigators have designed a community-based intervention study to all subjects attended in drug addiction centers screened for hepatitis C virus (HCV) to evaluate the efficacy and acceptance of a telemedicine based programme versus conventional healthcare assistance

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 5, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

4.5 years

First QC Date

July 23, 2019

Last Update Submit

May 17, 2023

Conditions

Hepatitis C Virus Infection

Keywords

ScreeningTelemedicineDiagnosis

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the intervention

    Compliance rate (number of patients of the overall participants) with the programme which includes completing screening, liver disease evaluation, treatment and follow-up visit at 12 week

    12 months

Secondary Outcomes (6)

  • Acceptance of the intervention with validated satisfaction questionnaire

    12 months

  • Sustained virological response rate

    12 months

  • Time to sustained virological response rate

    12 months

  • Adherence rate to follow-up

    12 months

  • Demographic factors associated with drop-outs

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Conventional care

NO INTERVENTION

Screening HCV with dried blod spot (DBS) testing and referral to tertiary care hospital to evaluate disease stage and treatment of HCV RNA positive patients

Telemedicine care

ACTIVE COMPARATOR

Two-way videoconference to evaluate the need of screening with DBS, disease stage evaluation and treatment of HCV RNA positive patients at drug addiction centers

Behavioral: Telemedicine based healthcare programme

Interventions

Telemedicine based healthcare programmeBEHAVIORAL

Two-way videoconference to evaluate the need of screening with DBS, disease stage evaluation and treatment of HCV RNA positive patients at drug addiction centers

Telemedicine care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 18 years old or older with a valid sanitary card in our public health system
  • Signed Informed consent
  • Tested for HCV: a) no previous documented HCV antibody request or b) with a previous positive HCV antibody test without RNA result or positive result without treatment or confirmed sustained virological response or c) with a negative HCV antibody result tested more than one year ago
  • No current surveillance by any hepatitis specialized care (hepatology or internal medicine)

You may not qualify if:

  • Previous DBS testing at DAC lost to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

RECRUITING

Related Publications (3)

  • Garcia-Fulgueiras A, Garcia-Pina R, Morant C, de Larrea-Baz NF, Alvarez E. Burden of disease related to hepatitis C and hepatitis B in Spain: a methodological challenge of an unfolding health problem. J Viral Hepat. 2011 Oct;18(10):e453-60. doi: 10.1111/j.1365-2893.2011.01467.x. Epub 2011 Jun 1.

    PMID: 21914063BACKGROUND

  • Vallejo F, Barrio G, Brugal MT, Pulido J, Toro C, Sordo L, Espelt A, Bravo MJ; Itinere Project Group. High hepatitis C virus prevalence and incidence in a community cohort of young heroin injectors in a context of extensive harm reduction programmes. J Epidemiol Community Health. 2015 Jun;69(6):599-603. doi: 10.1136/jech-2014-205070. Epub 2015 Apr 13.

    PMID: 25870164BACKGROUND

  • Coats JT, Dillon JF. The effect of introducing point-of-care or dried blood spot analysis on the uptake of hepatitis C virus testing in high-risk populations: A systematic review of the literature. Int J Drug Policy. 2015 Nov;26(11):1050-5. doi: 10.1016/j.drugpo.2015.05.001. Epub 2015 Jun 4.

    PMID: 26118799BACKGROUND

MeSH Terms

Conditions

Hepatitis CDisease

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Manuel Hernandez-Guerra, MD

    MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel N Hernandez-Guerra, MD

CONTACT

34922678559mhernand@ull.edu.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 29, 2019

Study Start

July 5, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)