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

Sponsor

University of La Laguna (Other)

Overall Status

Recruiting

CT.gov ID

NCT05146609

Collaborator

(none)

1,384

Enrollment

Location

Arms

Anticipated Duration (Months)

139

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Behavioral: Screening HCV. HR-HOSPITAL Behavioral: Screening HCV. HR-DDP Behavioral: Screening HCV. GP-HOSPITAL Behavioral: Screening HCV. GP-PCC	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1384 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Acceptance of the intervention [12 months]
Overall screening rate

Secondary Outcome Measures

Viability [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.
Participation [12 months]
Number of participants by sending their DBS and different possible factors associated to a higher rate of participation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Complejo Hospitalario Universitario de Canarias	La Laguna	Santa Cruz De Tenerife	Spain	38320

Sponsors and Collaborators

University of La Laguna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Manuel Hernandez-Guerra, MD, Medical Doctor, University of La Laguna

ClinicalTrials.gov Identifier:

NCT05146609

Other Study ID Numbers:

TGSS_EXCAD_AP

First Posted:

Dec 7, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis A

Hepatitis C

Hepatitis

Study Results

No Results Posted as of Mar 2, 2022