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NOT YET RECRUITING
NCT06604182
NA

Innovate, Involve, Inspire

Sponsor: Frontline AIDS

View on ClinicalTrials.gov

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.

Official title: Community-based HCV Testing and Treatment of People Who Inject Drugs: Innovate, Involve, Inspire

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

1454

Start Date

2025-01

Completion Date

2026-07

Last Updated

2024-09-19

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Community-based Simplified HCV Testing and Treatment Algorithm

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.