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Retrieval of Hepatitis C Patients Lost to Follow-up

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ClinicalTrials.gov Identifier: NCT04153708
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel Hernandez-Guerra, MD, University of La Laguna

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.

Condition or disease Intervention/treatment Phase
Hepatitis C 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to either call or mail invitation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial to Evaluate the Efficacy of Two Strategies to Linkage to Care Patients With Hepatitis C Lost to Follow-up
Actual Study Start Date : November 3, 2019
Estimated Primary Completion Date : June 3, 2020
Estimated Study Completion Date : August 3, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Acceptance of the intervention [ Time Frame: One month after the intervention ]
    Number of patients and % attending the clinic (linkage to care rate)


Secondary Outcome Measures :
  1. Effectiveness of the intervention [ Time Frame: 6 months after starting treatment ]
    Number of patients and % that cure the infection due to intervention (complete assessment and treatment rate).

  2. Viability of the intervention [ Time Frame: 1 week ]
    Number of patients with unavailable or inaccurate data for contact

  3. Factors associated with viability of the strategies [ Time Frame: 6 months ]
    Rate of patients with predictive factors associated to outcome 1



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153708


Contacts
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Contact: Manuel Hernandez-guerra, MD 666866237 mhernand@ull.edu.es

Locations
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Spain
Manuel Hernandez-Guerra Recruiting
La Laguna, Santa Cruz De Tenerife, Spain, 38320
Contact: Manuel Hernandez-guerra, MD    666866237    mhernand@ull.edu.es   
Sponsors and Collaborators
University of La Laguna
Investigators
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Study Chair: Enrique Quintero Carrion, MD Hospital Universitario de Canarias
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Responsible Party: Manuel Hernandez-Guerra, MD, Principal Investigator, University of La Laguna
ClinicalTrials.gov Identifier: NCT04153708    
Other Study ID Numbers: CHUC_2019 23
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manuel Hernandez-Guerra, MD, University of La Laguna:
hepatitis C
lost to follow-up
microelimination
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antibodies
Immunoglobulins
Hepatitis C Antibodies
Immunologic Factors
Physiological Effects of Drugs