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

Plain English summary of protocol

Background and study aims
Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). As many as 43 million people globally do not know their HCV status and of those that are diagnosed, only about one-quarter have been treated. Vietnam faces a high burden of HCV disease, with the highest prevalence observed among people living with HIV (PLHIV) and key populations (KPs) including gay men, transgender women, drug users and sex workers. HCV self-testing (HCVST) has been identified as an innovative approach to increase uptake and diagnosis among people at high risk of HCV and link them to care and treatment to achieve the elimination of HCV by 2030. This study aims to add to the evidence base on optimal approaches for delivering HCVST and priority populations for HCVST programs by evaluating the relative effectiveness of three types of HCVST models in reaching first-time HCV testers as compared to routine provider-led testing.

Who can participate?
Key populations (people who inject drugs, gay men and other men who have sex with men, transgender women, and female sex workers) and PLHIV who are 18 years or older and of any gender. Participants must have an unknown HCV status or have not been tested for HCV within the last 6 months.

What does the study involve?
Participants are asked to join this study when seeking HCV testing services at a health facility, community-based organization (CBO) or online. The study will offer participants a choice of (1) HCV testing options, i.e., provider-led or self-testing; (2) HCV self-test type, i.e., a fingerprick blood test or oral test using a mouth swab, and (3) support in using the test, i.e., with assistance from a healthcare provider or without direct assistance from a healthcare provider. These options will be offered through three models: (1) facility-based distribution (i.e., at clinics and health facilities); (2) community-based primary and secondary distribution at CBOs; and (3) virtual distribution via an online ordering platform. Data will be collected through a cross-sectional survey, programmatic monitoring, cost records, focus group discussions and in-depth interviews with clients, service providers, and program leaders to assess the effectiveness, acceptability, preferences, feasibility, and willingness to pay for HCVST; measure linkage to care; and analyze cost-benefit of an HCVST intervention in Vietnam.

What are the possible benefits and risks of participating?
There are no direct benefits to study participants when they participate in this study. However, participants will have the chance to learn if they are infected with HCV, and infected individuals will be able to receive free confirmatory testing and treatment services. In terms of risks, study participants may feel discomfort when using the finger prick as it may cause a little pain and bleeding or may feel discomfort when swabbing themselves for saliva. The participants may also feel uncomfortable with some of the questions that will be asked. Finally, there is a risk that participants' involvement in the study could become known to others and that social harm may result (i.e., because participants could become known as HIV- or HCV- infected or at "high risk" for HIV/HCV infection).

Where is the study run from?
PATH (Viet Nam)

When is the study starting and how long is it expected to run for?
July 2022 to January 2024

Who is funding the study?
Unitaid (Viet Nam)

Who is the main contact?
Dr Bao Ngoc Vu, bvu@path.org

Contact information

Dr Bao Ngoc Vu
Principal Investigator

#1101, 11th Floor
Hanoi Towers
49 Hai Ba Trung Street
Hoan Kiem District
Hanoi
-
Viet Nam

ORCID ID	0000-0002-5529-5411
Phone	+84 (0)97231 9562
Email	bvu@path.org

Study information

Eligibility

Locations

Countries of recruitment

• Viet Nam

Study participating centres

Sponsor information

Funders

Funder type

Other

Results and Publications

Study outputs

Additional files

ISRCTN16503177 Plain English results HCVST Study Factsheet.pdf

Editorial Notes

05/02/2025: A file of plain English results was uploaded as an additional file.
12/08/2024: The intention to publish date was changed from 01/08/2024 to 01/12/2024.
03/01/2024: The following changes were made to the study record:
1. First Response® HCV card test kit, Premier Medical Corps Ltd was removed from Drug/device/biological/vaccine name(s).
2. The recruitment start date was changed from 20/07/2023 to 01/09/2023.
3. The recruitment end date was changed from 30/01/2024 to 14/11/2023.
4. The target number of participants was changed from 10,000 to 2882.
5. Total final enrolment added.
02/06/2023: The following changes were made to the trial record:
1. The overall end date was changed from 30/10/2023 to 30/01/2024.
2. The recruitment start date was changed from 15/06/2023 to 20/07/2023.
3. The recruitment end date was changed from 30/10/2023 to 30/01/2024.
4. The plain English summary was updated to reflect these changes.
04/05/2023: The following updates have been made to the study record and the plain English summary updated accordingly:
1. The recruitment start date was changed from 15/05/2023 to 15/06/2023.
2. The recruitment end date was changed from 30/09/2023 to 30/10/2023.
07/03/2023: The following updates have been made to the study record and the plain English summary updated accordingly:
1. The recruitment start date was changed from 15/03/2023 to 15/05/2023.
2. The recruitment end date was changed from 30/06/2023 to 30/09/2023.
3. The overall trial end date was changed from 30/09/2023 to 30/10/2023.
06/02/2023: The recruitment start date was changed from 01/02/2023 to 15/03/2023.
11/01/2023: Ethics approval details amended.
10/01/2023: Ethics approval details added.
04/10/2022: The recruitment start date was changed from 25/10/2022 to 01/02/2023. Ethics approval details added.
07/09/2022: Trial's existence confirmed by Population Services International (PSI).