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

University of La Laguna

Status: Enrolling

Conditions: Hepatitis C

Treatments: Behavioral: Screening HCV. GP-HOSPITAL; Behavioral: Screening HCV. GP-PCC; Behavioral: Screening HCV. HR-DDP; Behavioral: Screening HCV. HR-HOSPITAL

Study type: Interventional

Funder types: Other

Identifiers

NCT05146609

TGSS_EXCAD_AP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,384 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,384 participants in 4 patient groups

HR-HOSPITAL

Experimental group

Description:

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.

Treatment:

Behavioral: Screening HCV. HR-HOSPITAL

HR-DDP

Experimental group

Description:

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.

Treatment:

Behavioral: Screening HCV. HR-DDP

GP-HOSPITAL

Experimental group

Description:

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.

Treatment:

Behavioral: Screening HCV. GP-HOSPITAL

GP-PCC

Experimental group

Description:

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.

Treatment:

Behavioral: Screening HCV. GP-PCC