<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036059</url>
  </required_header>
  <id_info>
    <org_study_id>TMA 2015 CDF - 976</org_study_id>
    <nct_id>NCT03036059</nct_id>
  </id_info>
  <brief_title>Twice Yearly Treatment for the Control of LF</brief_title>
  <official_title>Cluster Randomized Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Noguchi Memorial Institute for Medical Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ghana Health Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Noguchi Memorial Institute for Medical Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation&#xD;
      sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6&#xD;
      rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is&#xD;
      Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In Ghana,&#xD;
      MDA has been undertaken since 2001. While the disease has been eliminated in many areas,&#xD;
      transmission has persisted in some implementation units that had experienced 15 or more&#xD;
      rounds of MDA. Alternative intervention strategies, including twice yearly MDA and sleeping&#xD;
      under insecticidal nets have significantly accelerated transmission interruption in some&#xD;
      settings of high transmission intensity. Thus, it is evident that new intervention strategies&#xD;
      could eliminate residual infection in areas of persistent transmission and speed up the LF&#xD;
      elimination process. This study therefore seeks to test the hypothesis that biannual&#xD;
      treatment of LF endemic communities will accelerate interruption of LF transmission.&#xD;
&#xD;
      Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The&#xD;
      interventions will be yearly or twice-yearly MDA delivered to entire endemic communities.&#xD;
      Allocation to study group will be by clusters identified using the prevalence of LF. Clusters&#xD;
      will be randomised to one of two groups: receiving either (1) annual treatment with IVM+ALB;&#xD;
      (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The primary&#xD;
      outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys.&#xD;
      Entomological assessments will also be undertaken to evaluate the transmission intensity of&#xD;
      the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a&#xD;
      random subsample of participants, microfilaria prevalence will be assessed longitudinally. A&#xD;
      nested process evaluation, using semi-structured interviews, focus group discussions and a&#xD;
      stakeholder analysis, will investigate the community acceptability, feasibility and scale-up&#xD;
      of each delivery system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 19, 2017</start_date>
  <completion_date type="Actual">December 8, 2019</completion_date>
  <primary_completion_date type="Actual">December 8, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline prevalence of Lymphatic Filariasis at 24 months</measure>
    <time_frame>0 and 24 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment</measure>
    <time_frame>0, 12, 24, 30 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions</measure>
    <time_frame>24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1462</enrollment>
  <condition>Lymphatic Filariasis</condition>
  <condition>Helminth Infection</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expanded frequency group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400 μg/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>400 μg/kg Ivermectin + 400 mg Albendazole</intervention_name>
    <description>400ug/Kg, tablet, given orally once or twice a year.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Expanded frequency group</arm_group_label>
    <other_name>Mectizan, Stromectol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residency in the disease endemic community for at least 12 months&#xD;
&#xD;
          -  Willingness to provide informed consent/assent&#xD;
&#xD;
          -  Willingness to donate blood (per the protocol)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent residents (&lt;12 months)&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Children below the age of 5.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dziedzom K de Souza, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Noguchi Memorial Institute for Medical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Noguchi Memorial Institute for Medical Research</name>
      <address>
        <city>Legon-Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 3, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Twice a year treatment</keyword>
  <keyword>Biannual treatment</keyword>
  <keyword>Wuchereria bancrofti</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Filariasis</mesh_term>
    <mesh_term>Elephantiasis, Filarial</mesh_term>
    <mesh_term>Helminthiasis</mesh_term>
    <mesh_term>Elephantiasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivermectin</mesh_term>
    <mesh_term>Albendazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036059
org study id: TMA 2015 CDF - 976
nct id: NCT03036059
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: Change from baseline prevalence of Lymphatic Filariasis at 24 months
time frame: 0 and 24 months
description: 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
measure: Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment
time frame: 0, 12, 24, 30 months
description: 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.
measure: Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions
time frame: 24 months
description: 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.
measure: Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions
time frame: 24 months
description: 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.
arm group label: Control group
arm group type: Active Comparator
description: 400 μg/kg Ivermectin + 400 mg Albendazole Tablets given every year for 2 years
arm group label: Expanded frequency group
arm group type: Experimental
description: 400 μg/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years
intervention type: Drug
intervention name: 400 μg/kg Ivermectin + 400 mg Albendazole
description: 400ug/Kg, tablet, given orally once or twice a year.
arm group label: Control group
arm group label: Expanded frequency group
other name: Mectizan, Stromectol
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dziedzom K de Souza, PhD
role: Principal Investigator
affiliation: Noguchi Memorial Institute for Medical Research
facility: 
country: Ghana
responsible party type: Sponsor
mesh term: Infections
mesh term: Filariasis
mesh term: Elephantiasis, Filarial
mesh term: Helminthiasis
mesh term: Elephantiasis
mesh term: Ivermectin
mesh term: Albendazole
sharing ipd: No
ipd 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.