Abstract
BackgroundThe Global Programme for the Elimination of Lymphatic Filariasis (GPELF) has been in operation since the year 2000, with the aim of eliminating the disease by the year 2020, following five to six rounds of effective annual mass drug administration (MDA). The treatment regimen is ivermectin (IVM) in combination with diethylcarbamazine (DEC) or albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Thus, new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the lymphatic filariasis (LF)-elimination process. This study, therefore, seeks to test the hypothesis that biannual treatment of LF-endemic communities will accelerate the interruption of LF in areas of persistent transmission.MethodsA cluster randomised trial will be implemented in LF-endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM + ALB or (2) annual MDA with IVM + ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system.DiscussionIt is expected that this study will add to the existing evidence on the need for alternative intervention strategies for the elimination of LF in Ghana and in other African countries that are facing similar challenges or are at the beginning of their LF-elimination programmes.Trial registrationClinicalTrials.gov, ID: NCT03036059. Registered on 26 January 2017.Pan African Clinical Trials Registry, ID: PACTR201702002012425. Registered on 23 February 2017.
Highlights
The Global Programme for the Elimination of Lymphatic Filariasis (GPELF) has been in operation since the year 2000, with the aim of eliminating the disease by the year 2020, following five to six rounds of effective annual mass drug administration (MDA)
IgG4 antibody testing using the Wb123 assay will be used in a subset of study participants, and the results evaluated together with the antigen and microscopy results
It is assumed that all community members will actively take part in the MDA programme, in order to achieve high therapeutic coverage
Summary
The publication of this research protocol follows the SPIRIT (Standard Protocol Items for Randomised Trials) recommendations [20]. 18 communities were selected, distributed into three districts in the Western Region of Ghana (Fig. 3). In these districts, the persistent transmission of LF has been reported following several rounds of MDA [8] and previous studies indicated inaccuracies in the treatment coverage data reported [22]. Meetings will be held with the NTDP, and at each study site, where key stakeholders (chiefs, community leaders and study participants) will be sensitised about the study objectives, interventions, evaluation procedures, and requested to provide input as well as the need for their participation in the study. Date of first enrolment Target sample size Recruitment status Primary outcome(s)
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