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Assessing the effectiveness of hepatitis C self-testing distribution models in Vietnam

Assessing the relative effectiveness of three models of hepatitis C (HCV) self-testing as compared to routine provider-led testing in reaching first-time HCV testers among key populations, people living with HIV and their partners in Vietnam

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN16503177
Enrollment
2882
Registered
2022-09-08
Start date
2023-09-01
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screening for hepatitis C virus (HCV) among key populations, people living with HIV and their partners who have unknown HCV status Infections and Infestations

Interventions

The study will be implemented through two phases, i.e., Phase I (active study phase) and Phase II (routine HCVST delivery). Phase I: This phase is comprised of a cross-sectional implementation scien
uses cascade metrics and visualization to measure the relative strength of linkage from HCV antibody reactivity to confirmation testing and direct-acting antiviral enrollment among those opting for HC
and conducts focus group discussions with a key population (KP) and people living with HIV (PLHIV) HCVST users to explore the relative acceptability and preferences for HCVST. During phase I, HIV-neg

Sponsors

PATH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years of age or older 2. Unknown HCV status or not tested for HCV within the last 6 months 3. Agreed to provide consent for participation in the study 4. Have access to a reliable phone for follow-up (for those opting for unassisted HCVST)

Exclusion criteria

Exclusion criteria: Individuals who have been diagnosed with chronic HCV and are on treatment

Design outcomes

Primary

MeasureTime frame
Effectiveness of HCVST distribution models in reaching first-time HCV testers is measured using a cross-sectional survey in Phase I and an HCV testing e-log book in Phase II

Secondary

MeasureTime frame
1. Acceptability of secondary HCVST distribution among KP who seek primary HCVST as part of the community distribution model is measured using a cross-sectional survey and HCV testing e-log book in Phase I 2. Linkage of those that test HCV antibody reactive to confirmatory testing, diagnosis, and treatment is measured using an e-logbook and client FGDs in Phase I and an e-logbook and online HCV risk screener in Phase II 3. Acceptability of and preferences for HCVST models are measured using a cross-sectional survey and FGDs with clients and providers in Phase I and an e-logbook in Phase II 4. Operational feasibility of integrating HCVST into HIV and harm reduction services is measured using FGDs with clients and providers in Phase I and IDIs with decision-makers in Phase II 5. Willingness to pay for routine provider-led anti-HCV testing and HCVST tests is measured using a cross-sectional survey in Phase I 6. Relative cost of the three HCVST distribution models as compared to routine provider-led anti-HCV testing is measured using an Excel worksheet in both Phases I and II

Countries

Viet Nam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026