Twice Yearly Treatment for the Control of LF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-19

Study Completion Date

2019-12-08

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.

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Detailed Description

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Conditions

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Lymphatic Filariasis Helminth Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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Control group

400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years

Group Type ACTIVE_COMPARATOR

400 μg/kg Ivermectin + 400 mg Albendazole

Intervention Type DRUG

400ug/Kg, tablet, given orally once or twice a year.

Expanded frequency group

400 μg/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years

Group Type EXPERIMENTAL

400 μg/kg Ivermectin + 400 mg Albendazole

Intervention Type DRUG

400ug/Kg, tablet, given orally once or twice a year.

Interventions

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400 μg/kg Ivermectin + 400 mg Albendazole

400ug/Kg, tablet, given orally once or twice a year.

Intervention Type DRUG

Other Intervention Names

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Mectizan, Stromectol

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)