Retrieval of Hepatitis C Patients Lost to Follow-up

A Clinical Trial to Evaluate the Efficacy of Two Strategies to Linkage to Care Patients With Hepatitis C Lost to Follow-up

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C
• Intervention / Treatment: Behavioral: Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call.; Behavioral: Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letter

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.

• Study Type: Interventional
• Enrollment (Anticipated): 352
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Hernandez-guerra, MD; Phone Number: 666866237; Email: mhernand@ull.edu.es

Study Locations

• Spain
  • Santa Cruz De Tenerife
    • La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Recruiting
      • Manuel Hernandez-Guerra
      • Contact: Manuel Hernandez-guerra, MD; Phone Number: 666866237; Email: mhernand@ull.edu.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance of the intervention	Number of patients and % attending the clinic (linkage to care rate)	One month after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the intervention	Number of patients and % that cure the infection due to intervention (complete assessment and treatment rate).	6 months after starting treatment
Viability of the intervention	Number of patients with unavailable or inaccurate data for contact	1 week
Factors associated with viability of the strategies	Rate of patients with predictive factors associated to outcome 1	6 months

Collaborators and Investigators

• Sponsor: University of La Laguna
• Investigators: Study Chair: Enrique Quintero Carrion, MD, Hospital Universitario de Canarias

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: hepatitis C; lost to follow-up; microelimination
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Hepatitis C Antibodies
• Other Study ID Numbers: CHUC_2019 23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No