Retrieval of Hepatitis C Patients Lost to Follow-up

NCT04153708 | Unknown

• 1 other identifier: CHUC_2019 23
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

hepatitis C; lost to follow-up; microelimination

Outcome Measures

Primary Outcomes (1)

• Acceptance of the intervention

  Number of patients and % attending the clinic (linkage to care rate)

  One month after the intervention

Secondary Outcomes (3)

• Effectiveness of the intervention

  6 months after starting treatment

• Viability of the intervention

  1 week

• Factors associated with viability of the strategies

  6 months

Study Arms (2)

Retrieval by phone call.

EXPERIMENTAL

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.

Retrieval by mail letter

ACTIVE COMPARATOR

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

Interventions

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

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

Retrieval by phone call.

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

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

Retrieval by mail letter

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• 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)
• Patients a valid sanitary card in our public health system
• Patients with available data for contact)

You may not qualify if:

• Belong to another catchment area. Current surveillance by any HCV specialist and/or record of sustained virological response.
• Severe comorbidity with an expected survival lower than 1 year.

Sponsors & Collaborators

• University of La Laguna: lead

Study Sites (1)

Manuel Hernandez-Guerra

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Enrique Quintero Carrion, MD

  Hospital Universitario de Canarias

  STUDY CHAIR

Central Study Contacts

Manuel Hernandez-guerra, MD

CONTACT

666866237; mhernand@ull.edu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized to either call or mail invitation

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 6, 2019
• Study Start: November 3, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)