Study on end-user insights towards alternative sample types and point-of-care diagnostic for TB testing in Viet Nam for DriveDx4TB

What is the study rationale?

The DriveDx4TB project, a multi-year portfolio led by FIND, aims at overcoming existing barriers associated with current tuberculosis (TB) diagnostics. It seeks to accelerate the development and evidence generation of new near and true point-of-care TB diagnostic technologies, including alternative sample types like urine, buccal, and tongue swabs, in addition to sputum.

The main assumption is that bringing testing closer to patients, combined with non-sputum samples, will enhance accessibility for vulnerable populations and reduce patient wait times and attrition along the care continuum. However, there is still limited evidence regarding the acceptability of these novel sample types for TB diagnostics among intended recipients and end-users. Additionally, the key characteristics required in each novel sample type to ensure usability, integration, and impact on TB outcomes within national health systems remain unknown.

To fill these gaps, we conduct a sequential mixed-method, formative study to explore end-user insights on non-sputum sampling and diagnostics. The findings inform the development of patient-centered novel TB diagnostics and related materials that are user-friendly and efficient. The study is a part of a multi-country research initiative, which includes Viet Nam, India, and South Africa. This multi-country study is a component of the DriveDx4TB project.

Why are we working on it?

We recognize the significance of delivering TB diagnostic services effectively to individuals with TB symptoms. Identifying TB cases early and providing timely treatment can minimize the severity of the disease and reduce mortality. However, the existing tests for TB in Viet Nam face challenges in terms of accessibility and ease of use at healthcare clinics. Many of these tests rely on sputum samples, causing delays, especially for those unable to produce sputum. Our study aims to improve TB testing by understanding end-user perspectives, enhancing usability, and expanding access to TB diagnostics for both patients and healthcare providers.

What are its objectives?

The study aims to achieve the following specific objectives:

  • To ascertain end-user/recipient insights on key characteristics of two novel TB sample types and sampling mechanisms, and the contexts in which each sample type/mechanism would be preferred.
  • To assess the acceptability, integration and implementation of two novel TB sample types within the existing TB systems, from healthcare workers (HCW), civil society (CS) stakeholders and public health experts

What is the study design?

Using a mixed-method approach, our study explores perceptions regarding various components of novel TB sample types and to triangulate findings by study population and data type (quantitative and qualitative).

The study combined 2 component – surveys and cognitive interviews:

  • Surveys: A total of 290 surveys are conducted across all four study populations to collect insights. These includes 150 surveys with TB service recipients, 20 with civil society stakeholders, 100 with healthcare workers, and 20 with public health experts.
  • Cognitive interviews: To refine diagnostic materials and assess user comprehension, approximately 10 healthcare workers, 5 public health experts and 5 civil society stakeholders will participate in cognitive interviews.

What is the study population?

Our study includes four crucial populations – TB service recipients, civil society stakeholders, healthcare workers, and public health experts. Each population plays a vital role in the successful implementation and impact of novel TB sample types.

What is the time scale?

The project is scheduled to run from October 2022 to December 2023.

Partners and Funding

This study is a collaborative effort between FIND Viet Nam and the Health Strategy and Policy Institute, Ministry of Health, funded by Unitaid  and the Australian Department of Foreign Affairs and Trade and as part of the DriveDx4TB.