Innovate, Involve, Inspire

Not Applicable

Not yet recruiting

• Conditions: HCV
• Interventions: Other: Community-based Simplified HCV Testing and Treatment Algorithm

• Registration Number: NCT06604182
• Lead Sponsor: Frontline AIDS

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.

Study Timeline

• Study First Submitted: 2024-07-08
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2025-01
• Primary Completion: 2026-06
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1454

Inclusion Criteria

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

Exclusion Criteria

• No meeting inclusion criteria
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCV positive	Community-based Simplified HCV Testing and Treatment Algorithm	Eligible participants that are HCV infected.

Primary Outcome Measures

Name	Time	Method
Number of participants successfully completing HCV treatment	15 months	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.

Secondary Outcome Measures

Name	Time	Method
The percentage of participants with treatment satisfaction using a tool called: Health seeking behavior and health service utilization	15 months	The tool will measure, in the last 6 months, the number of times participants 1. seeked medical assistance, 2. if assistance was provided, 3. the reason for not seeking assistance (if relevant) and 4. treatment satisfaction (if assistance was provided). These multiple measurements will be aggregated to give a score per participant used to classify participants into percentage with and without treatment satisfaction.