Adoption and uptake of the lateral flow urine LAM test in countries with high tuberculosis and HIV/AIDS burden: current landscape and barriers

Diane N Singhroy; Emily MacLean; Mikashmi Kohli; Erica Lessem; David Branigan; Kathleen England; Khairunisa Suleiman; Paul K Drain; Morten Ruhwald; Samuel Schumacher; Claudia M Denkinger; Brenda Waning; Wayne Van Gemert; Madhukar Pai

doi:10.12688/gatesopenres.13112.2

Adoption and uptake of the lateral flow urine LAM test in countries with high tuberculosis and HIV/AIDS burden: current landscape and barriers

Gates Open Res. 2020 Apr 7:4:24. doi: 10.12688/gatesopenres.13112.2. eCollection 2020.

Authors

Diane N Singhroy¹, Emily MacLean^{1

2}, Mikashmi Kohli¹, Erica Lessem³, David Branigan³, Kathleen England⁴, Khairunisa Suleiman⁵, Paul K Drain⁶, Morten Ruhwald⁷, Samuel Schumacher⁷, Claudia M Denkinger⁸, Brenda Waning⁹, Wayne Van Gemert⁹, Madhukar Pai^{1

2}

Affiliations

¹ McGill International TB Centre, McGill University, Montreal, QC, H4B1X5, Canada.
² Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada.
³ Department of Tuberculosis, Treatment Action Group, New York, NY, USA.
⁴ Independent Consultant, Los Angeles, CA, USA.
⁵ Independent Consultant, Istanbul, Turkey.
⁶ Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA, USA.
⁷ Department of Tuberculosis, Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
⁸ Division of Tropical Medicine, Center of Infectious Diseases, University of Heidelberg, Heidelberg, Germany.
⁹ Stop TB Partnership, Global Drug Facility, Geneva, Geneva, Switzerland.

Abstract

Background: Since 2015, the World Health Organization (WHO) has recommended a commercially available lateral-flow urine LAM test (Alere-LAM) to assist in the diagnosis of tuberculosis (TB) in severely ill people living with HIV (PLHIV). The test can rapidly detect TB in severely ill PLHIV and can identify PLHIV most at-risk of death, leading to mortality reductions. However, its uptake in countries with high burdens of TB and HIV has been slow. To assess the current use landscape and identify barriers to the adoption of Alere-LAM, we conducted a questionnaire-based study in 31 high TB and HIV/AIDS burden countries. Methods: Between November 2018 and December 2019, we collected responses to a semi-structured questionnaire that had been emailed to staff and affiliates of National TB Programs or HIV/AIDS Programs, Ministries of Health, and TB or HIV institutes of 31 high TB/HIV burden countries. Questions concerned country policies, adoption, and current use of Alere-LAM testing, as well as testing algorithms and barriers preventing Alere-LAM uptake. Results: We received questionnaire responses from 24 out of 31 (77%) high TB/HIV burden countries. Of these 24 countries, 11 (46%) had adopted Alere-LAM policies, with only five (21%) countries currently using Alere-LAM testing. Testing algorithms were generally aligned with WHO recommendations. Fifteen countries (63%) said they were planning to implement Alere-LAM testing in the near future. The most commonly cited constraint to adoption and implementation was budget limitations. Additional barriers to Alere-LAM implementation included lack of country-specific data and piloting, administrative hurdles such as regulatory agency approval, lack of coordination between National TB and HIV programs, and small perceived patient population. Conclusion: Responses to our questionnaire demonstrate the persistent gap between country-level policy and real-world use of Alere-LAM, as well as specific barriers that must be addressed to scale-up testing in PLHIV.

Keywords: LAM; barriers; lipoarabinomannan; policy; rapid testing; tuberculosis; urine.

Grants and funding

This work was initially supported by the Bill and Melinda Gates Foundation [OPP1061487]. Subsequent updates were supported by Global Drug Facility, Stop TB Partnership, and FIND, Geneva.