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The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID
trial testing Screening for HCV in PWID and Linkage-To-Care in Hepatitis C in 529 participants. Completed in 10 May 2019.
| Lead sponsor | Hospital Universitario Infanta Leonor |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 529 |
| Start date | 15 January 2017 |
| Primary completion | 31 December 2018 |
| Estimated completion | 10 May 2019 |
Hospital Universitario Infanta Leonor
18 and older, any sex, with Hepatitis C or Drug Users. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of participants who had a positive HCV test and results of the test was delivered to them.
| Group | Value | 95% CI |
|---|---|---|
| Participatnts With an Active HCV Infection | 101 |
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).
| Group | Value | 95% CI |
|---|---|---|
| HCV Infected Patients | 63 |
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).
| Group | Value | 95% CI |
|---|---|---|
| HCV Infected Patients | 52 |
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).
| Group | Value | 95% CI |
|---|---|---|
| HCV Infected Patients | 38 | |
| Patients Who Started HCV Therapy | 38 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Total Patients | 122 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Total Patients | 35 |
| Group | Value | 95% CI |
|---|---|---|
| Total Patients | 23 |
| Group | Value | 95% CI |
|---|---|---|
| Total Patients | 2 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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