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Prevalence of LF Infection in Districts Not Included in LF Control Activities

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ClinicalTrials.gov Identifier: NCT03131401
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Ghana Health Service, Neglected Tropical Diseases Program
Information provided by (Responsible Party):
Noguchi Memorial Institute for Medical Research

Brief Summary:

Lymphatic filariasis is a neglected tropical disease earmarked for elimination as a public health problem by the year 2020. Since the year 2000, the Global Program for the Elimination of LF has together with endemic countries undertaken preventive chemotherapy in endemic districts to entire at risk populations. In Ghana, treatment of LF is based on the drugs Ivermectin and Albendazole. Remarkable achievements have been made towards the control and elimination of LF in Ghana. However, there remain programmatic and implementation challenges that need to be addressed in order to ensure that the gains made over the last 15 years are sustained. Among these challenges is the persistent transmission of LF in some districts despite more than 10 years of MDA.

Furthermore, LF cases have been identified in communities from eight districts, previously considered as non-endemic. The extent of endemicity in these new districts is unknown. In order to achieve the 2020 elimination targets, it is crucial to determine the distribution and infection prevalence of LF in these districts. Evaluating these districts for LF endemicity will help the implementation of appropriate strategies towards achieving the 2020 target.

This protocol describes the surveys to be undertaken in Ghana in 3 of these districts. The current standard mapping methodologies of LF have the potential to miss LF endemic villages, due to the focal nature of LF. As such, in order to enhance the chances to detect endemic communities, this survey will use a combination of the WHO EPI cluster survey and current LF mapping protocols. 15 communities will be selected in each district, with 100 survey participants per community. Survey participants will be screened for LF infection using immunological and parasitological methods. Study participants will also be tested for onchocerciasis infection using immunological and parasitological methods in districts where LF and oncho are co-endemic. The information from this survey will be combined with the data on the LF vectors and their infection status in the survey areas and relevant data available at the Ghana Health Service to:

  1. determine whether LF intervention strategies are indicated in these three districts,
  2. design, as indicated, appropriate intervention strategies to achieve LF elimination in these three districts by 2020
  3. inform, if indicated, co-implementation of control, monitoring and evaluation for LF and onchocerciasis in the two onchocerciasis endemic districts
  4. extract lessons learnt for the design and implementation of surveys in the other districts currently considered non-endemic but where LF cases have been reported.

New rapid diagnostic tests have been developed to assess infection Lf and onchocerciasis infection prevalence at the time of the decision to stop MDA and for surveillance for new infections once MDA has been stopped. These include Rapid Diagnostic Tests (RDT) for antibodies against the W. bancrofti antigen WB123 and the O. volvulus antigen Ov16. These tests still require large scale field validation. Provided additional funding becomes available, this survey will be used to obtain field validation data.


Condition or disease Intervention/treatment
Lymphatic Filariases Onchocerciasis Diagnostic Test: Diagnosis of lymphatic filariasis Diagnostic Test: Diagnosis of lymphatic Filariasis and onchocerciasis Diagnostic Test: DEC Patch

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Study Type : Observational
Actual Enrollment : 3736 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Determination of the Prevalence of LF Infection in Districts Not Included in LF Control Activities and of the Basis for Integrated Implementation of LF - Onchocerciasis Elimination Strategies in Potentially Co-endemic Areas
Actual Study Start Date : January 21, 2018
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Diagnosis of lymphatic filariasis
    Field validation of the diagnostic performance of diagnostic tests for infection with W. bancrofti.
    Other Names:
    • Filaria Test Strip
    • Wb123 RDT
  • Diagnostic Test: Diagnosis of lymphatic Filariasis and onchocerciasis
    Field validation of the diagnostic performance of diagnostic tests for infection with both W. bancrofti and O. volvulus.
    Other Name: Wb123-Ov16 RDT
  • Diagnostic Test: DEC Patch
    Field validation of the diagnostic performance of diagnostic tests for infection with O. volvulus.
    Other Name: Diagnosis of onchocerciasis


Primary Outcome Measures :
  1. Prevalence of lymphatic Filariasis [ Time Frame: 3 months ]
    To determine the prevalence and distribution of LF infection in three districts previously considered non-endemic but reporting LF cases

  2. Measures of protection [ Time Frame: 3 months ]
    To determine what measures the population in these districts use to protect themselves from mosquito bites

  3. Prevalence on Onchocerciasis [ Time Frame: 3 months ]
    To determine the prevalence and intensity of infection with O. volvulus in two of these three districts known to be onchocerciasis endemic

  4. Vectors of lymphatic Filariasis [ Time Frame: 6 months ]
    To determine the LF vectors in three districts considered non-endemic for LF

  5. Wuchereria bancrofti infection in vectors [ Time Frame: 12 months ]
    To assess the prevalence of W. bancrofti infection in mosquitoes in these districts.


Secondary Outcome Measures :
  1. Performance of diagnostic tests [ Time Frame: 12 months ]
    To characterize the diagnostic performance via the standard parameters sensitivity and specificity of different diagnostic tests


Biospecimen Retention:   Samples With DNA
Only parasite positive blood specimen and DNA will be retained.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The study will be conducted in districts considered non-endemic for LF based on the Ghana wide LF mapping conducted in 2000, but where LF cases have been identified. These districts fall within the Eastern and Volta Regions. At least one district has been selected in each of these regions. The selected study districts are East Akim, Hohoe and Adaklu. East Akim and Hohoe districts are also endemic for onchocerciasis.
Criteria

Inclusion Criteria:

  • Willingness to provide informed consent (or assent with parental/guardian consent)
  • Age ≥ 5 years
  • Residency in the study villages since birth or for at least the previous five years

Exclusion Criteria:

  • Inability to come out of bed
  • Feeling sick
  • Inability to provide consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131401


Locations
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Ghana
Villages in Eastern and Volta Region
Eastern And Volta Regions, Ghana
Sponsors and Collaborators
Noguchi Memorial Institute for Medical Research
Ghana Health Service, Neglected Tropical Diseases Program
Investigators
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Principal Investigator: Daniel A Boakye, PhD Noguchi Memorial Institute for Medical Research

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Responsible Party: Noguchi Memorial Institute for Medical Research
ClinicalTrials.gov Identifier: NCT03131401     History of Changes
Other Study ID Numbers: TDR B40376
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Filariasis
Elephantiasis, Filarial
Onchocerciasis
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases