Acceptance of Hepatitis C Screening by Self-testing in High Risk and General Population

December 2, 2023 updated by: Manuel Hernandez-Guerra, MD, University of La Laguna
The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing assisted by center of origin or referral hospital, as a strategy for screening for hepatitis C virus (HCV) in high risk population (ex-users of drug dependence centers) compared to the general population assisted by primary care centers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized clinical trial involving patients who between 2013 and 2017 have contacted the drug dependence center and patients from general population.

After selecting those who do not meet any exclusion criteria, a letter will be sent to them inviting them to participate in this study. This letter will contain the study information sheet and informed consent, and a self-testing kit with an explanatory leaflet so that each person can carry out the test in a simple and easy way.

The main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (DBS) testing, to study whether support improves participation and to identify predictors of participation.

For the present study, assuming an increase of 18% participation (from 18% to 28% offering support by the patient's referral center, and based on a previous study in our environment of self-testing in the general population), taking into account a power of 80%, alpha error of 5%, and losses of 20%, will require 346 patients per group.

Study Type

Interventional

Enrollment (Estimated)

1384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Recruiting
        • Complejo Hospitalario Universitario de Canarias
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • All subjects who have contacted a drug dependence center between 2013 and 2017, as well as patients from a group of a primary care center.
  • Signed informed consent.

Exclusion criteria:

  • Patient's refusal to participate in the study.
  • Negative HCV serology or viral load in the last year.
  • Death.
  • Belonging to another health area
  • Not having the patient's address in the hospital's computer system.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HR-HOSPITAL
Patients assigned to the strategy HR-HOSPITAL, who are high risk population (HR), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital.
Behavioral: Screening HCV. HR-HOSPITAL
Screening HCV in high risk population by themselves or at referral hospital.
Experimental: HR-DDP
Patients assigned to the strategy HR-DDP, who are high risk population, will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the drug dependence center (DDP) the participants used to attend.
Behavioral: Screening HCV. HR-DDP
Screening HCV in high risk population by themselves or at drug dependence center.
Experimental: GP-HOSPITAL
Patients assigned to the strategy GP-HOSPITAL, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the referral hospital.
Behavioral: Screening HCV. GP-HOSPITAL
Screening HCV in general population by themselves or at referral hospital.
Experimental: GP-PCC
Patients assigned to the strategy GP-PCC, who are general population (GP), will receive an invitation letter for HCV screening with DBS to be performed by themselves or at the primary care center (PCC) to be performed by the general practitioner.
Behavioral: Screening HCV. GP-PCC
Screening HCV in general population by themselves or at primary care center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance of the intervention
Time Frame: 12 months
Overall screening rate
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viability
Time Frame: 12 months
The investigators will measure and report the amount of DBS received from the participants, taking into account the group to which the participants belong.
12 months
Participation
Time Frame: 12 months
Number of participants by sending their DBS and different possible factors associated to a higher rate of participation.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of La Laguna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 2, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGSS_EXCAD_AP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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