Trial Outcomes & Findings for The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID (NCT NCT02971488)
NCT ID: NCT02971488
Last Updated: 2019-09-13
Results Overview
Percentage of participants who had a positive HCV test and results of the test was delivered to them.
COMPLETED
529 participants
2 years
2019-09-13
Participant Flow
Participant milestones
| Measure |
Total Patients
All the patients in the study
|
|---|---|
|
Overall Study
STARTED
|
529
|
|
Overall Study
COMPLETED
|
529
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Persons Who Inject Drugs (PWID)
n=529 Participants
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.
|
|---|---|
|
Age, Continuous
|
42 years
n=529 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=529 Participants
|
|
Sex: Female, Male
Male
|
420 Participants
n=529 Participants
|
|
Region of Enrollment
Spain
|
529 participants
n=529 Participants
|
|
Homelessness
|
105 Participants
n=529 Participants
|
|
Spanish born
|
419 Participants
n=529 Participants
|
|
Type of drug used
Heroine
|
412 Participants
n=529 Participants
|
|
Type of drug used
Cocaine
|
476 Participants
n=529 Participants
|
|
Type of drug used
Alcohol
|
50 Participants
n=529 Participants
|
|
Current way of administration of drug
Injected
|
177 Participants
n=529 Participants
|
|
Current way of administration of drug
Smoked
|
432 Participants
n=529 Participants
|
|
Current way of administration of drug
Snorted
|
135 Participants
n=529 Participants
|
|
Retained in care
|
449 Participants
n=529 Participants
|
|
Never tested
Never tested for HIV
|
57 Participants
n=529 Participants
|
|
Never tested
Never tested for HCV
|
55 Participants
n=529 Participants
|
|
Participants with Opioid Substitute Treatment (OST)
|
142 Participants
n=529 Participants
|
|
Stable partner
|
204 Participants
n=529 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPercentage of participants who had a positive HCV test and results of the test was delivered to them.
Outcome measures
| Measure |
Participatnts With an Active HCV Infection
n=122 Participants
Participants who had tested positive for hepatitis C (Positive PCR).
|
Patients Who Started HCV Therapy
HCV infected Patients who started treatment with antivirals
|
|---|---|---|
|
Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to
|
101 Participants
|
—
|
PRIMARY outcome
Timeframe: 2 yearsEvaluation 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).
Outcome measures
| Measure |
Participatnts With an Active HCV Infection
n=122 Participants
Participants who had tested positive for hepatitis C (Positive PCR).
|
Patients Who Started HCV Therapy
HCV infected Patients who started treatment with antivirals
|
|---|---|---|
|
Percentage of Participants Who Were Evaluated at a HCV Clinic.
|
63 Participants
|
—
|
PRIMARY outcome
Timeframe: 2 yearsEvaluation 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).
Outcome measures
| Measure |
Participatnts With an Active HCV Infection
n=122 Participants
Participants who had tested positive for hepatitis C (Positive PCR).
|
Patients Who Started HCV Therapy
HCV infected Patients who started treatment with antivirals
|
|---|---|---|
|
Percentage of Participants Who Started HCV Antiviral Therapy.
|
52 Participants
|
—
|
PRIMARY outcome
Timeframe: 2 yearsEvaluation 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).
Outcome measures
| Measure |
Participatnts With an Active HCV Infection
n=122 Participants
Participants who had tested positive for hepatitis C (Positive PCR).
|
Patients Who Started HCV Therapy
n=52 Participants
HCV infected Patients who started treatment with antivirals
|
|---|---|---|
|
Percentage of Participants Who Achieved a Sustained Virological Response (SVR)
|
38 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 2 yearsScreening 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.
Outcome measures
| Measure |
Participatnts With an Active HCV Infection
n=529 Participants
Participants who had tested positive for hepatitis C (Positive PCR).
|
Patients Who Started HCV Therapy
HCV infected Patients who started treatment with antivirals
|
|---|---|---|
|
Percentage of Participants With Active HCV in Screened Population
|
122 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsOther 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.
Outcome measures
| Measure |
Participatnts With an Active HCV Infection
n=529 Participants
Participants who had tested positive for hepatitis C (Positive PCR).
|
Patients Who Started HCV Therapy
HCV infected Patients who started treatment with antivirals
|
|---|---|---|
|
Prevalence of Other Chronic Viral Infections in the Population Screened
HIV infection
|
35 Participants
|
—
|
|
Prevalence of Other Chronic Viral Infections in the Population Screened
Hepatitis B Antigen
|
23 Participants
|
—
|
|
Prevalence of Other Chronic Viral Infections in the Population Screened
Hepatitis D
|
2 Participants
|
—
|
Adverse Events
Total Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place