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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatitis C

Intervention / Treatment
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* Behavioral: Screening HCV. HR-HOSPITAL
* Behavioral: Screening HCV. HR-DDP
* Behavioral: Screening HCV. GP-HOSPITAL
* Behavioral: Screening HCV. GP-PCC


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR-HOSPITAL<br>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<br>* Screening HCV in high risk population by themselves or at referral hospital.<br>|
| Experimental: HR-DDP<br>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<br>* Screening HCV in high risk population by themselves or at drug dependence center.<br>|
| Experimental: GP-HOSPITAL<br>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<br>* Screening HCV in general population by themselves or at referral hospital.<br>|
| Experimental: GP-PCC<br>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<br>* Screening HCV in general population by themselves or at primary care center.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viability | 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 | Number of participants by sending their DBS and different possible factors associated to a higher rate of participation. | 12 months |