A Community-based Intervention Among Active Drug Users in Montpellier

Drug Use Clinical Trial

— ICONE  

Official title:

Towards Ending HCV Infection Among Active Drug Users: a Community-based Intervention in Montpellier.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008927
• Other study ID #: ANRS 95050 ICONE
• Status: Completed
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: September 10, 2021

Study information

• Verified date: July 2022
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to assess the effectiveness of a community-based model of HCV mass screening associated with an immediate HCV treatment on the cascade of care among active drug users (DUs) in the city of Montpellier, France.

Description:

Active DUs will be recruited using a Respondent-Driven Sampling (RDS) method. Hosted in the temporary community care facility (the research site), located outside the existing care facilities in the city, participants will benefit from HCV/HIV/HBV screening, on-site measurement of HCV-RNA and liver fibrosis, early treatment, treatment follow-up and risk and harm reduction tools related to their risk practices. Peers will be present in this unique structure and will accompany participants throughout their treatment. Participants will be referred during treatment to existing care facilities but followed up in the research up to 44 to 48 weeks after initiation of treatment to assess the rate of re-infection. The number of active DUs in the population will be estimated by using a capture/recapture method nested in the RDS survey

Secondary objectives of the research are:

• To estimate the seroprevalence of hepatitis C in active DUs in Montpellier;

• To estimate the size of the active DUs population in the city of Montpellier using a capture/recapture method;

• To estimate HCV care cascade steps in active DUs in Montpellier;

• To identify the factors associated with HCV treatment failure;

• To determine the proportion of treated and cured HCV patients who re-infect within months after end of treatment;

• To estimate the seroprevalence of hepatitis B and HIV infection in active DUs in Montpellier.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age> 18 years

• Be an active drug user defined by:

1. Report current and regular (Last uptake no more than 3 days ago and at least 10 times a month) use of illicit psychoactive substances other than cannabis (heroin, amphetamines, cocaine, MDMA/ecstasy, cathinones) or misused medications (methadone, buprenorphine, opiate drugs, methylphenidate, ketamine) AND

2. Positive urine test for a psychoactive substance other than cannabis (Heroin, amphetamines, cocaine, MDMA/ecstasy, cathinones) or a misused medication (methadone, buprenorphine, opiate drugs, methylphenidate, ketamine).

Exclusion Criteria:

• Inability to understand the study

• Be under guardianship, curatorship or future protection mandate

• Lack of informed consent

Related Conditions & MeSH terms

• Drug Use
• HCV Infection
• Hepatitis C
• Infections

Intervention

Diagnostic Test:
• HCV screening
All patients will have HCV screening using rapid tests. HIV and HBV testing will also be conducted and patients will be appropriately referred to appropriate health services.
• Diagnosis of hepatitis C
HCV-RNA assay (GeneXpert, Cepheid) will be performed for all participants with positive HCV serology to determine if patients have chronic hepatitis C (defined by HCV-RNA>10 UI/mL). In addition a measure of the liver stiffness will be performed.

Drug:
• HCV treatment
Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment.

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

France, 

References & Publications (7)

Blackburn NA, Patel RC, Zibbell JE. Improving Screening Methods for Hepatitis C Among People Who Inject Drugs: Findings from the HepTLC Initiative, 2012-2014. Public Health Rep. 2016 May-Jun;131 Suppl 2:91-7. — View Citation

Chevaliez S, Poiteau L, Rosa I, Soulier A, Roudot-Thoraval F, Laperche S, Hézode C, Pawlotsky JM. Prospective assessment of rapid diagnostic tests for the detection of antibodies to hepatitis C virus, a tool for improving access to care. Clin Microbiol Infect. 2016 May;22(5):459.e1-6. doi: 10.1016/j.cmi.2016.01.009. Epub 2016 Jan 22. — View Citation

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. — View Citation

Des Jarlais D, Duong HT, Pham Minh K, Khuat OH, Nham TT, Arasteh K, Feelemyer J, Heckathorn DD, Peries M, Moles JP, Laureillard D, Nagot N; (The Drive Study Team). Integrated respondent-driven sampling and peer support for persons who inject drugs in Haiphong, Vietnam: a case study with implications for interventions. AIDS Care. 2016 Oct;28(10):1312-5. doi: 10.1080/09540121.2016.1178698. Epub 2016 May 13. — View Citation

Des Jarlais D, Khue PM, Feelemyer J, Arasteh K, Thi Huong D, Thi Hai Oanh K, Thi Giang H, Thi Tuyet Thanh N, Vinh VH, Heckathorn DD, Moles JP, Vallo R, Quillet C, Rapoud D, Michel L, Laureillard D, Hammett T, Nagot N. Using dual capture/recapture studies to estimate the population size of persons who inject drugs (PWID) in the city of Hai Phong, Vietnam. Drug Alcohol Depend. 2018 Apr 1;185:106-111. doi: 10.1016/j.drugalcdep.2017.11.033. Epub 2018 Feb 2. — View Citation

Dore GJ, Altice F, Litwin AH, Dalgard O, Gane EJ, Shibolet O, Luetkemeyer A, Nahass R, Peng CY, Conway B, Grebely J, Howe AY, Gendrano IN, Chen E, Huang HC, Dutko FJ, Nickle DC, Nguyen BY, Wahl J, Barr E, Robertson MN, Platt HL; C-EDGE CO-STAR Study Group. Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial. Ann Intern Med. 2016 Nov 1;165(9):625-634. doi: 10.7326/M16-0816. Epub 2016 Aug 9. — View Citation

Leon L, Kasereka S, Barin F, Larsen C, Weill-Barillet L, Pascal X, Chevaliez S, Pillonel J, Jauffret-Roustide M, LE Strat Y. Age- and time-dependent prevalence and incidence of hepatitis C virus infection in drug users in France, 2004-2011: model-based estimation from two national cross-sectional serosurveys. Epidemiol Infect. 2017 Apr;145(5):895-907. doi: 10.1017/S0950268816002934. Epub 2016 Dec 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of treated and cured DU participants.	Proportion of treated and cured DU participants among those with a detectable HCV-RNA at pre-inclusion.	SVR12 (12 weeks after end of HCV treatment)
Secondary	Proportion of participants with a HCV positive serology	Proportion of participants with a HCV positive serology among all participants	Screening RDS
Secondary	Estimated number of drug users in the city of Montpellier	Estimated number of drug users in the city of Montpellier by capture/recapture survey	Screening RDS
Secondary	Proportion of participants with detectable HCV-RNA	Proportion of patients with HCV RNA > 10 IU/mL among those with positive HCV serology	Screening RDS
Secondary	Proportion of participants initiating anti-viral treatment	Proportion of patients with chronic hepatitis who initiate the treatment among patients with HCV-RNA >10 UI/mL	Day 0
Secondary	Rate of reinfection	Proportion of cured participants re-infected within months after end of treatment defined by positive HCV-RNA of different genotype at SVR12 or by positive HCV-RNA at W44/48	Week 48
Secondary	Hepatitis B infection rate	Proportion of participants with HBs antigene and positive B-DNA at baseline	Screening RDS
Secondary	HIV infection rate and ART coverage	Proportion of participants with positive HIV serology at baseline and proportion of participants with anti-viral treatment among HIV positive participants at baseline	Screening RDS

External Links

•   Combating Hepatitis B and C to reach elimination by 2030. WHO, 2016