Twice Yearly Treatment for the Control of LF

February 25, 2020 updated by: Noguchi Memorial Institute for Medical Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1462

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Legon-Accra, Ghana
        • Noguchi Memorial Institute for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control group
400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years
Drug: 400 μg/kg Ivermectin + 400 mg Albendazole
400ug/Kg, tablet, given orally once or twice a year.
Other Names:
  • Mectizan, Stromectol
EXPERIMENTAL: Expanded frequency group
400 μg/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years
Drug: 400 μg/kg Ivermectin + 400 mg Albendazole
400ug/Kg, tablet, given orally once or twice a year.
Other Names:
  • Mectizan, Stromectol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline prevalence of Lymphatic Filariasis at 24 months
Time Frame: 0 and 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
Time Frame: 0, 12, 24, 30 months
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
Time Frame: 24 months
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
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noguchi Memorial Institute for Medical Research

Collaborators

Ghana Health Services

Investigators

  • Principal Investigator: Dziedzom K de Souza, PhD, Noguchi Memorial Institute for Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 19, 2017

Primary Completion (ACTUAL)

December 8, 2019

Study Completion (ACTUAL)

December 8, 2019

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

January 26, 2017

First Posted (ESTIMATE)

January 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMA 2015 CDF - 976

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared publicly. Researchers interested in the data can contact the principal investigator directly. No personal identifying information will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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