Clinical trial NCT03939013: Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar)
Official title: Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: hepatitis C
Myanmar
primary care
direct acting antivirals
Lead sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Sponsor class: OTHER
Collaborators: name: Myanmar Liver Foundation
name: Foundation for Innovative New Diagnostics, Switzerland
name: UNITAID
First posted: 2019-05-06
Enrollment: 634
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Access to point-of-care hepatitis C testing in community setting to facilitate hepatitis C treatment.
Primary purpose: DIAGNOSTIC

Brief summary: Implementation-effectiveness hybrid trial assessing acceptability, feasibility and cost-effectiveness of community-based point-of-care testing and treatment for hepatitis C. Utilises Cepheid GeneXpert HCV VL device as diagnostic tool (diagnosis of chronic infection and assessment of treatment outcome) and sofosbuvir/daclatasvir for HCV therapy (local standard of care).

Detailed description: Historically, testing and treatment for hepatitis C has been confined to centralised laboratories and tertiary hospitals respectively. Recent advancements in point-of-care testing for hepatitis C (anti-HCV antibody and HCV RNA/VL) and treatment options with the introduction of direct acting antivirals allows for testing and treatment to occur in de-centralised primary care settings.

This study is an effectiveness-implementation hybrid study to assess the feasibility, acceptability, effectiveness and cost-effectiveness of a de-centralised approach to hepatitis C testing and treatment at community-based clinics in Yangon, Myanmar. Generalist doctors trained in hepatitis C treatment will prescribe direct acting antiviral therapy to eligible participants.

The study will utilise SD Bioline HCV RDT and Cepheid GeneXpert HCV VL test; and sofosbuvir/daclatasvir to treat hepatitis C. Test of cure will be performed at 12 weeks post-treatment completion to assess sustained virological response (SVR).

Study inclusion criteria prior to recruitment into study:

* Aged ≥18 years
* Attendance at study site
* Willing and able to provide written informed consent

Study exclusion criteria prior to recruitment into study:

* Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment
* Treatment experienced (either DAA or pegylated interferon)
* Hepatitis B virus (HBV) infected
* Human Immunodeficiency Virus (HIV) infected
* estimated glomerular filtration rate (eGFR) \<30
* Active tuberculosis (if known active tuberculosis or as per symptom screening assessment)
* Pregnant women
* Serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years
* Attendance at study site
* Willing and able to provide written informed consent

Exclusion Criteria:

* Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment
* Treatment experienced (either DAA or pegylated interferon)
* Hepatitis B virus (HBV) infected
* Human Immunodeficiency Virus (HIV) infected
* estimated glomerular filtration rate (eGFR) \<30
* Active tuberculosis (if known active tuberculosis or as per symptom screening assessment)
* Pregnant women
* Serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking

Primary outcomes:
measure: Proportion of Ab positive patients who receive GeneXpert HCV VL test
timeFrame: 6-9 months of recruitment
measure: Proportion of RNA positive patients who receive direct-acting antiviral therapy for chronic hepatitis C infection
timeFrame: 9-12 months of recruitment & treatment
measure: Proportion of patients who complete direct-acting antiviral therapy for chronic hepatitis C infection
timeFrame: 9-18 months
measure: Proportion of patients who achieve SVR12 who started on direct-acting antiviral therapy for chronic hepatitis C infection
timeFrame: 9-18 months
Secondary outcomes:
measure: Satisfaction of testing and treatment pathway among patients
timeFrame: 6-18 months
measure: Costing of testing and treatment pathway at community site
timeFrame: 6-18 months
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: Myanmar Liver Foundation Than Sitt Charity Clinic
city: Yangon
country: Myanmar
facility: Thingangyun Clinic
Study officials:
affiliation: Burnet Institute
name: Margaret Hellard
role: PRINCIPAL_INVESTIGATOR
affiliation: Burnet Institute
name: Hla Htay
role: PRINCIPAL_INVESTIGATOR
References:
citation: Draper BL, Yee WL, Shilton S, Bowring A, Htay H, Nwe N, Markby J, Kyi KP, Easterbrook P, Naing W, Win TM, Aung KS, Howell J, Pedrana A, Hellard M. Feasibility of decentralised, task-shifted hepatitis C testing and treatment services in urban Myanmar: implications for scale-up. BMJ Open. 2022 May 3;12(5):e059639. doi: 10.1136/bmjopen-2021-059639.