Innovate, Involve, Inspire
Community-based HCV Testing and Treatment of People Who Inject Drugs: Innovate, Involve, Inspire
1 other identifier
interventional
1,454
0 countries
N/A
Brief Summary
The study will test a Community-based Simplified HCV Testing and Treatment Algorithm (CBSA), implemented at community harm reduction fixed or mobile sites. All potential participants with positive anti-HCV test will undergo diagnostic procedures including HCV-RNA testing. Those eligible for CBSA will be prescribed a fixed dose combination tablet: sofosbuvir/daclatasvir. Sustained virologic response (SVR) will be assessed 12 weeks after treatment completion. All those who achieve SVR will be tested for HCV\_RNA at six and 12 months after SVR12.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
September 19, 2024
September 1, 2024
1.4 years
July 8, 2024
September 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants successfully completing HCV treatment
Hepatitis C screening, confirmation and treatment will be monitored for the number of confirmed positive participants that enroll and complete treatment. Suppression of the virus will be recorded per participant as well as re-infection rates up to 1 year after treatment was completed.
15 months
Secondary Outcomes (1)
The percentage of participants with treatment satisfaction using a tool called: Health seeking behavior and health service utilization
15 months
Study Arms (1)
HCV positive
EXPERIMENTALEligible participants that are HCV infected.
Interventions
The distinctive features of CBSA are: (i) community-based service provision, substantially lowering the threshold for HCV services and eliminating the need to visit health care facilities for the majority of patients; (ii) the use of simple, once-daily, pan-genotypic HCV treatment regimens; (iii) a minimum of required laboratory tests and assessments; (iv) task sharing of essential functions from physicians to the case-managers; (v) integration of HCV testing and treatment with existing harm reduction services, addressing multiple health needs and facilitating patient-centered care.
Eligibility Criteria
You may qualify if:
- Drug use in the past 90 days
- Age 18 and above
- Positive for HCV RNA
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Frontline AIDSlead
- Alliance for the Public's Healthcollaborator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2024
First Posted
September 19, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share