Drug Users, Harm Reduction, Hepatitis C, HIV
Conditions
Keywords
Hepatitis C, PWID, Linkage-to-care
Brief summary
Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. More frequent diagnosis, new methods that prevent loss of tracking, and access to antiviral treatment are all strategies that must be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.
Interventions
OTHERScreening for HCV in PWID and Linkage-To-Care
Screening, diagnosis and treatment of HCV in PWID, will be part of a harm reduction strategy. Treatment of HCV infected PWID will be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population.
Sponsors
Instituto de Salud Carlos III
Fundacion SEIMC-GESIDA
Hospital Universitario Infanta Leonor
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* PWID * \>18 years of age * Signed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to | 2 years | Percentage of participants who had a positive HCV test and results of the test was delivered to them. |
| Percentage of Participants Who Were Evaluated at a HCV Clinic. | 2 years | Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response). |
| Percentage of Participants Who Started HCV Antiviral Therapy. | 2 years | Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response). |
| Percentage of Participants Who Achieved a Sustained Virological Response (SVR) | 2 years | Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Active HCV in Screened Population | 2 years | Screening for HCV using dried blood samples on WhatmanTM cards in subjects from Cañada Real based on the results of the laboratory tests performed in phase I. The percentage of active HCV infections will be calculated from the total population of active drug addicts screened. |
| Prevalence of Other Chronic Viral Infections in the Population Screened | 2 years | Other viruses (HIV, HBV, HDV) using dried blood samples on WhatmanTM cards in subjects from Cañada Real based will be analysed. The prevalence of these infections will be calculated base on the total screened population. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Persons Who Inject Drugs (PWID) The study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed.
Screening for hepatitis C virus (HCV) in PWID and Linkage-To-Care: Screening, diagnosis and treatment of HCV in PWID, will be part of a harm reduction strategy.
Treatment of HCV infected PWID will be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. | 529 |
| Total | 529 |
Baseline characteristics
| Characteristic | Persons Who Inject Drugs (PWID) | — |
|---|---|---|
| Age, Continuous | 42 years | — |
| Current way of administration of drug Injected | 177 Participants | — |
| Current way of administration of drug Smoked | 432 Participants | — |
| Current way of administration of drug Snorted | 135 Participants | — |
| Homelessness | 105 Participants | — |
| Never tested Never tested for HCV | 55 Participants | — |
| Never tested Never tested for HIV | 57 Participants | — |
| Participants with Opioid Substitute Treatment (OST) | 142 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Spain | 529 participants | — |
| Retained in care | 449 Participants | — |
| Sex: Female, Male Female | 109 Participants | — |
| Sex: Female, Male Male | 420 Participants | — |
| Spanish born | 419 Participants | — |
| Stable partner | 204 Participants | — |
| Type of drug used Alcohol | 50 Participants | — |
| Type of drug used Cocaine | 476 Participants | — |
| Type of drug used Heroine | 412 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 529 |
| other Total, other adverse events | 0 / 529 |
| serious Total, serious adverse events | 0 / 529 |
Outcome results
Primary
Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to
Percentage of participants who had a positive HCV test and results of the test was delivered to them.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participatnts With an Active HCV Infection | Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to | 101 Participants |
Primary
Percentage of Participants Who Achieved a Sustained Virological Response (SVR)
Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participatnts With an Active HCV Infection | Percentage of Participants Who Achieved a Sustained Virological Response (SVR) | 38 Participants |
| Patients Who Started HCV Therapy | Percentage of Participants Who Achieved a Sustained Virological Response (SVR) | 38 Participants |
Primary
Percentage of Participants Who Started HCV Antiviral Therapy.
Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participatnts With an Active HCV Infection | Percentage of Participants Who Started HCV Antiviral Therapy. | 52 Participants |
Primary
Percentage of Participants Who Were Evaluated at a HCV Clinic.
Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participatnts With an Active HCV Infection | Percentage of Participants Who Were Evaluated at a HCV Clinic. | 63 Participants |
Secondary
Percentage of Participants With Active HCV in Screened Population
Screening for HCV using dried blood samples on WhatmanTM cards in subjects from Cañada Real based on the results of the laboratory tests performed in phase I. The percentage of active HCV infections will be calculated from the total population of active drug addicts screened.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participatnts With an Active HCV Infection | Percentage of Participants With Active HCV in Screened Population | 122 Participants |
Secondary
Prevalence of Other Chronic Viral Infections in the Population Screened
Other viruses (HIV, HBV, HDV) using dried blood samples on WhatmanTM cards in subjects from Cañada Real based will be analysed. The prevalence of these infections will be calculated base on the total screened population.
Time frame: 2 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participatnts With an Active HCV Infection | Prevalence of Other Chronic Viral Infections in the Population Screened | HIV infection | 35 Participants |
| Participatnts With an Active HCV Infection | Prevalence of Other Chronic Viral Infections in the Population Screened | Hepatitis B Antigen | 23 Participants |
| Participatnts With an Active HCV Infection | Prevalence of Other Chronic Viral Infections in the Population Screened | Hepatitis D | 2 Participants |