The DOLF project (www.dolfproject.wustl.edu) led clinical trials and community studies of the safety and efficacy of a single-dose triple-drug therapy (IDA) for Lymphatic Filariasis (LF). IDA is now being used in mass drug administration (MDA) programs in many countries to accelerate LF elimination. This work was supported by grants from the Bill & Melinda Gates Foundation, and the studies were performed by team members that included talented colleagues in six LF-endemic countries. The IDA story is prominently featured in a special supplement that was recently published online in the American Journal of Tropical Medicine and Hygiene. Articles in the supplement share experiences, innovative approaches, and challenges encountered during as a major research advance moved toward policy change and implementation.
DOLF team members who co-authored articles in the supplement include Co-Principal Investigators Gary Weil and Peter Fischer at Washington University, Christopher King (Case–Western Reserve University), Christine Dubray (CDC), and Alison Krentel at Bruyere Research Institute (Ottawa), Myra Hardy (Royal Children’s Hospital Melbourne), and a long list of colleagues based in LF-endemic countries. One of the articles in the supplement recounts lessons learned and practical challenges that research teams faced in conducting large population-based safety and efficacy studies in diverse field settings. From troubleshooting how to deal with poor internet connections in India and Papua New Guinea to participant “MDA fatigue” in Haiti, ethical review board delays in Fiji, and lack of housing at field sites for team members in Indonesia, this paper illustrates obstacles the teams faced and solutions that were often improvised under stress and time pressure.
In the article “Lessons from Large-Scale Tolerability and Acceptability Studies of Triple Drug Mass Drug Administration Performed to Support Policy Change and Accelerate Elimination of Lymphatic Filariasis” Drs. Weil, Fischer and Krentel discuss best practices based on their experiences leading IDA studies. They recommend the following: early involvement of project stakeholders to work towards a shared goal; involve experienced leaders on the ground who are able to navigate country-specific bureaucracy and barriers; strong central management to align protocols via standard operating procedures and data management systems with onsite training; and an early understanding that acceptability studies in target populations are needed in addition to clinical trial data to support policy change.
Finally, in a article co-authored by Anastasia Pantelias (Bridges to Development, Seattle), Jonathan D. King (WHO, Geneva), Patrick Lammie (Taskforce for Global Health, Atlanta), and Gary Weil described how a multi-stakeholder, public-private partnership led to accelerated development and validation of a new diagnostic test for LF. Among recommendations for similar projects in the future (diagnostic tests for neglected tropical diseases or NTDs), the authors suggested obtaining significant input from end-users early in the design process and consideration of various business models to determine whether bundling several NTD diagnostic tests might be more attractive to manufacturers.
A link to the full supplement can be found here: https://www.ajtmh.org/page/ida