NCT04411381

Brief Summary

To achieve World Health Organization 2030 goals of hepatitis C elimination it is mandatory to document after treatment sustained virological response (SVR). Currently, patients after completing treatment do not show up for SVR assessment. The main objective of this study is to evaluate the effectiveness of a telemedicine-based model of care associated with dried blood spot testing at home to assess hepatitis C sustained virological response after treatment compared to the traditional model of care.

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
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

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

May 25, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

3.5 years

First QC Date

May 27, 2020

Last Update Submit

May 17, 2023

Conditions

Hepatitis CTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of the two models of care

    SVR record rate

    12 months

Secondary Outcomes (1)

  • Acceptance of the intervention with a validated satisfaction questionnaire

    12 months

Study Arms (2)

Telemedicine-based model of care

ACTIVE COMPARATOR

Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination

Other: Telemedicine

Traditional model of care

NO INTERVENTION

Tradiotional model of care with venipuncture for RNA test to sustained virological response determination and face-to-face consultation

Interventions

TelemedicineOTHER

Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination

Telemedicine-based model of care

Eligibility Criteria

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

You may qualify if:

  • years or older
  • have contact telephone number
  • sing the informed consent

You may not qualify if:

  • have advanced fibrosis (F3) or cirrhosis (F4)
  • are under surveillance by another specialist or drug addition center.

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 (4)

  • Gomez L, Reygosa C, Morales-Arraez DE, Ramos R, Perez A, Hernandez A, Quintero E, Gutierrez F, Diaz-Flores F, Hernandez-Guerra M. Diagnostic test accuracy of the cobas 6800 system for detection of hepatitis c virus viraemia levels from dried blood spots. Enferm Infecc Microbiol Clin (Engl Ed). 2020 Jun-Jul;38(6):267-274. doi: 10.1016/j.eimc.2019.10.009. Epub 2019 Dec 4. English, Spanish.

    PMID: 31812456BACKGROUND

  • Averhoff F, Shadaker S, Gamkrelidze A, Kuchuloria T, Gvinjilia L, Getia V, Sergeenko D, Butsashvili M, Tsertsvadze T, Sharvadze L, Zarkua J, Skaggs B, Nasrullah M. Progress and challenges of a pioneering hepatitis C elimination program in the country of Georgia. J Hepatol. 2020 Apr;72(4):680-687. doi: 10.1016/j.jhep.2019.11.019. Epub 2019 Dec 4.

    PMID: 31811882BACKGROUND

  • Cuadrado A, Llerena S, Cobo C, Pallas JR, Mateo M, Cabezas J, Fortea JI, Alvarez S, Pellon R, Crespo J, Echevarria S, Ayesa R, Setien E, Lopez-Hoyos M, Crespo-Facorro B, Aguero J, Chueca N, Garcia F, Calleja JL, Crespo J. Microenvironment Eradication of Hepatitis C: A Novel Treatment Paradigm. Am J Gastroenterol. 2018 Nov;113(11):1639-1648. doi: 10.1038/s41395-018-0157-x. Epub 2018 Jun 27.

    PMID: 29946175BACKGROUND

  • Jimenez Galan G, Alia Alia C, Vegue Gonzalez M, Garcia Berriguete RM feminine, Fernandez Gonzalez F, Fernandez Rodriguez CM, Gonzalez Fernandez M, Gutierrez Garcia ML, Losa JE, Velasco M, Moreno L, Hervas R, Delgado-Iribarren A, Palacios Garcia-Cervigon G. The contribution of telemedicine to hepatitis C elimination in a correctional facility. Rev Esp Enferm Dig. 2019 Jul;111(7):550-555. doi: 10.17235/reed.2019.6152/2018.

    PMID: 31215210BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Manuel Hernández-Guerra, PhD

CONTACT

34922678559mhernand@ull.edu.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gastroenterology and Hepatology

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 2, 2020

Study Start

May 25, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)