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Innovate, Involve, Inspire

NCT06604182 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1454

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • HCV

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.

Sponsors & Collaborators

  • Alliance for the Public's Health

    collaborator OTHER

  • Frontline AIDS

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-06-30
Completion
2026-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604182 on ClinicalTrials.gov