Retrieval of Hepatitis C Patients Lost to Follow-up

NCT ID: NCT04153708

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-03
• Study Completion Date: 2021-09-01

Brief Summary

The main purpose of the study is to compare the efficacy of two strategies aimed to rescue patients lost to follow-up with active infection or with positive HCV antibodies without RNA request to complete evaluation and prescription of treatment in cases of chronic infection. After patient identification from data files of laboratory and microbiology charts, patients will be randomized to: a) phone call, and b) invitation letter, both of two strategies including a scheduled appointment with the hepatologist.

Detailed Description

This is a prospective, randomized study in which subjects lost to follow-up with positive HCV antibodies without RNA request or positive RNA will be proposed to be brought back into care.

After patients identification from data files of laboratory and microbiology charts using three different cohorts in time (2005-07, 2011-11 and 2015-17), eligible patients (18 years of age or older, patients positive for HCV antibodies without RNA request or positive RNA lost to follow-up, with a valid sanitary card in our public health system and with available data for contact) will be randomized to: a) phone call (Strategy 1), and b) invitation letter (Strategy 2), both of two strategies including a scheduled appointment with the hepatologist.

Strategy 1 includes until three phone calls to contact patients and provide them with an appointment with the hepatologist (tertiary care center) over a period of 14 days according to patient availability. Instead, strategy 2 includes an invitation letter providing patients with the appointment with the hepatologist over a same period of time than strategy 1. If there is no response to calls or no attendance to the appointment after the letter (randomized strategy), the strategy will be switched to the another one.

Epidemiological, clinical, and laboratory variables will be registered.

The hypothesis of the study is that phone calls will improve the rate of linkage to care among HCV patients lost to follow-up compared to the invitation letter shipment. Therefore, call would be an effective strategy to rescue these patients.

For the present study, a 15% of improvement in linkage to care was hypothesized in the group of patients receiving the strategy 1 compared with the strategy 2. Taking into account a power of 80%, alpha error of 5% and losses of 10% will require 176 patients per strategy.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Retrieval by phone call.

Patients assigned to strategy 1 will be called to schedule an appointment with the hepatologist over a period of 14 days.

Group Type: EXPERIMENTAL

Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call.

Intervention Type: BEHAVIORAL

Patients assigned to strategy 1 will be called to schedule an appointment with the hepatologist over a period of 14 days.

Retrieval by mail letter

Patients assigned to strategy 2 will receive an invitation letter with an appointment with the hepatologist over a period of 14 days.

Group Type: ACTIVE_COMPARATOR

Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letter

Intervention Type: BEHAVIORAL

Patients assigned to strategy 2 will receive an invitation letter with an appointment with the hepatologist over a period of 14 days.

Interventions

Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call.

Patients assigned to strategy 1 will be called to schedule an appointment with the hepatologist over a period of 14 days.

Intervention Type: BEHAVIORAL

Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letter

Patients assigned to strategy 2 will receive an invitation letter with an appointment with the hepatologist over a period of 14 days.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 18 years of age or older

2. Record of positive HCV antibodies without RNA request or positive RNA lost to follow-up (non-treated patients with an active infection, without surveillance by any HCV specialist)

3. Patients a valid sanitary card in our public health system

4. Patients with available data for contact)

Exclusion Criteria

1. Belong to another catchment area. Current surveillance by any HCV specialist and/or record of sustained virological response.

2. Severe comorbidity with an expected survival lower than 1 year.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of La Laguna

OTHER

Sponsor Role: lead

Responsible Party

Manuel Hernandez-Guerra, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrique Quintero Carrion, MD

Role: STUDY_CHAIR

Hospital Universitario de Canarias

Locations

Manuel Hernandez-Guerra

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Manuel Hernandez-guerra, MD

Role: CONTACT

mhernand@ull.edu.es

666866237

Facility Contacts

Manuel Hernandez-guerra, MD

Role: primary

mhernand@ull.edu.es

666866237

Other Identifiers

CHUC_2019 23

Identifier Type: -

Identifier Source: org_study_id