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

Not Applicable

Recruiting

• Conditions: Hepatitis C
• Interventions: Behavioral: Screening HCV. HR-HOSPITAL; Behavioral: Screening HCV. HR-DDP; Behavioral: Screening HCV. GP-PCC; Behavioral: Screening HCV. GP-HOSPITAL

• Registration Number: NCT05146609
• Lead Sponsor: University of La Laguna

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.

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 Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-07
• Study Start: 2022-02-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-02
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1384

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HR-HOSPITAL	Screening HCV. 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.
HR-DDP	Screening HCV. 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.
GP-PCC	Screening HCV. 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.
GP-HOSPITAL	Screening HCV. 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.

Primary Outcome Measures

Name	Time	Method
Acceptance of the intervention	12 months	Overall screening rate

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Complejo Hospitalario Universitario de Canarias; 🇪🇸 La Laguna, Santa Cruz De Tenerife, Spain