Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604182
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Innovate Involve Inspire
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Community-based HCV Testing and Treatment of People Who Inject Drugs Innovate Involve Inspire
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sofosbuvirdaclatasvir
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
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 sofosbuvirdaclatasvir
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 WHOs 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 sofosbuvirdaclatasvir 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
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 WHOs 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 sofosbuvirdaclatasvir 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None