Twice Yearly Treatment for the Control of LF

Study Overview
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Brief Summary
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The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6 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. Alternative intervention strategies, including twice yearly MDA and sleeping under insecticidal nets have significantly accelerated transmission interruption in some settings of high transmission intensity. Thus, it is evident that new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the LF elimination process. This study therefore seeks to test the hypothesis that biannual treatment of LF endemic communities will accelerate interruption of LF transmission. Two cluster randomized trials 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; (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.

Official Title
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Cluster Randomized Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations

Conditions
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Lymphatic Filariasis, Helminth Infection

Intervention / Treatment
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* Drug: 400 μg/kg Ivermectin + 400 mg Albendazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Residency in the disease endemic community for at least 12 months Willingness to provide informed consent/assent Willingness to donate blood (per the protocol) Exclusion Criteria: Recent residents (<12 months) Inability to give informed consent Pregnant and lactating women Children below the age of 5.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years | Drug: 400 μg/kg Ivermectin + 400 mg Albendazole<br>* 400ug/Kg, tablet, given orally once or twice a year.<br>* Other names: Mectizan, Stromectol;|
| Experimental: Expanded frequency group<br>400 μg/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years | Drug: 400 μg/kg Ivermectin + 400 mg Albendazole<br>* 400ug/Kg, tablet, given orally once or twice a year.<br>* Other names: Mectizan, Stromectol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline prevalence of Lymphatic Filariasis at 24 months | The primary outcome, the prevalence of LF infection, will be measured through cross-sectional parasitological surveys conducted at baseline and at 24 months. The timing of the final follow-up survey will take into account differences in time since treatment of the annual and biannual treatment groups at 24 months | 0 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment | For the secondary outcome, a subsample of individuals from the clusters in each of the study groups will be followed longitudinally for two and half years, in order to better understand the transmission dynamics of LF and to estimate key parameters for mathematical modelling of transmission dynamics and treatment impact. | 0, 12, 24, 30 months | 
| Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions | A process evaluation, using semi-structured interviews, focus group discussions (FGDs) and a stakeholder analysis, will investigate the community acceptability of the twice-yearly drug administration. | 24 months | 
| Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions | A process evaluation, using semi-structured interviews, focus group discussions (FGDs) and a stakeholder analysis, will investigate the feasibility of scaling up the twice-yearly drug administration. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Twice a year treatment, Biannual treatment, Wuchereria bancrofti