Innovate, Involve, Inspire

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HCV
• Intervention / Treatment: Other: Community-based Simplified HCV Testing and Treatment Algorithm

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 Type: Interventional
• Enrollment (Estimated): 1454
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Meteliuk, PhD; Phone Number: +380988220510; Email: meteliuk@aph.org.ua
• Study Contact Backup: Name: Abraham J Olivier, PhD; Phone Number: +447775912022; Email: colivier@frontlineaids.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HCV positive; Eligible participants that are HCV infected.

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.; Other Names: CBSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of participants with treatment satisfaction using a tool called: Health seeking behavior and health service utilization	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.	15 months

Collaborators and Investigators

• Sponsor: Frontline AIDS
• Collaborators: Alliance for Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ERC.0004133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No