Innovate, Involve, Inspire

NCT ID: NCT06604182

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1454 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-07-31

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.

Detailed Description

People who inject drugs (PWID) bear the highest burden of the disease and due to multiple individual and structural barriers suffer from suboptimal access to accessing life-saving treatments. A range of interventions in the continuum of HCV testing and treatment have been suggested to address the specific needs of PWID. However, despite these advances, there is insufficient evidence on HCV integration in harm reduction from low-middle income countries, where the burden of HCV among people who inject drugs is the most significant.

This study seeks to contribute evidence to the global efforts in combating HCV among PWID, by identifying effective strategies to overcome barriers to testing and treatment, and ultimately advancing the goals of the WHO's global hepatitis strategy to eliminate HCV as a public health threat.

This is a mixed-methods observational cohort followed longitudinally with the core of the study intervention being the Community-Based Simplified HCV Testing and Treatment Algorithm (CBSA), described in detail below. CBSA is based on the latest WHO recommendations on HCV simplified service delivery, and clinical guidelines for non-specialized care settings. 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. 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.

The primary outcomes are based on the HCV treatment cascade: (a) Completing the pretreatment evaluation; (b) Initiating and completing the full DAA course; (c) Achieving SVR12; (d) Re-infection rate at six and 12 months after SVR12. Secondary outcomes include treatment motivation, adherence, quality of life, and treatment satisfaction. The qualitative component will explore client-level, provider-level, organizational, community-level, and structural factors influencing the integration of CBSA into harm reduction programs.

Conditions

HCV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HCV positive

Eligible participants that are HCV infected.

Group Type: EXPERIMENTAL

Community-based Simplified HCV Testing and Treatment Algorithm

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

CBSA

Eligibility Criteria

Inclusion Criteria

• Drug use in the past 90 days
• Age 18 and above
• Positive for HCV RNA

• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alliance for the Public's Health

OTHER

Sponsor Role: collaborator

Frontline AIDS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Anna Meteliuk, PhD

Role: CONTACT

meteliuk@aph.org.ua

+380988220510

Abraham J Olivier, PhD

Role: CONTACT

colivier@frontlineaids.org

+447775912022

Other Identifiers

ERC.0004133

Identifier Type: -

Identifier Source: org_study_id