Abstract
Background Lymphatic filariasis (LF) is targeted for global elimination through treatment of entire at-risk populations with repeated annual mass drug administration (MDA). Essential for program success is defining and confirming the appropriate endpoint for MDA when transmission is presumed to have reached a level low enough that it cannot be sustained even in the absence of drug intervention. Guidelines advanced by WHO call for a transmission assessment survey (TAS) to determine if MDA can be stopped within an LF evaluation unit (EU) after at least five effective rounds of annual treatment. To test the value and practicality of these guidelines, a multicenter operational research trial was undertaken in 11 countries covering various geographic and epidemiological settings.
Methodology The TAS was conducted twice in each EU with TAS-1 and TAS-2 approximately 24 months apart. Lot quality assurance sampling (LQAS) formed the basis of the TAS survey design but specific EU characteristics defined the survey site (school or community), eligible population (6-7 year olds or 1(st)-2(nd) graders), survey type (systematic or cluster-sampling), target sample size, and critical cutoff (a statistically powered threshold below which transmission is expected to be no longer sustainable). The primary diagnostic tools were the immunochromatographic (ICT) test for W. bancrofti EUs and the BmR1 test (Brugia Rapid or PanLF) for Brugia spp. EUs.
Principal Findings/Conclusions In 10 of 11 EUs, the number of TAS-1 positive cases was below the critical cutoff, indicating that MDA could be stopped. The same results were found in the follow-up TAS-2, therefore, confirming the previous decision outcome. Sample sizes were highly sex and age-representative and closely matched the target value after factoring in estimates of non-participation. The TAS was determined to be a practical and effective evaluation tool for stopping MDA although its validity for longer-term post-MDA surveillance requires further investigation.
Author Summary Lymphatic filariasis (LF) is targeted for global elimination through a strategy of repeated annual mass drug administration (MDA) to entire at-risk populations. A transmission assessment survey (TAS) is designed to evaluate whether transmission of LF is presumed to have reached a level low enough that it cannot be sustained in the absence of drug intervention and, therefore, MDA can be stopped. This multicenter operational research trial examines the value and practicality of the TAS guidelines through its implementation in 11 countries of diverse geographical and epidemiologic profiles. The field experiences support the TAS survey design methodology with particular respect to school and cluster-based sampling strategies. We found that sample sizes were age and sex representative and met the target values after factoring in estimates of non-participation rates. In 10 of 11 countries, the TAS found the number of positive cases in the evaluation unit to be no more than the statistically powered critical threshold. These results were corroborated in a follow-up TAS approximately 24 months later. We conclude the TAS is a valuable and effective tool for stopping MDA but its utility for longer-term post-MDA surveillance needs further empirical evidence and may be best supported with complementary tools and methods.