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Completed

NCT Number: NCT03131401

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

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnosis of lymphatic filariasis

Diagnostic Test

Field validation of the diagnostic performance of diagnostic tests for infection with W. bancrofti.

Other names: Filaria Test Strip, Wb123 RDT

Diagnosis of lymphatic Filariasis and onchocerciasis

Diagnostic Test

Field validation of the diagnostic performance of diagnostic tests for infection with both W. bancrofti and O. volvulus.

Other names: Wb123-Ov16 RDT

DEC Patch

Diagnostic Test

Field validation of the diagnostic performance of diagnostic tests for infection with O. volvulus.

Other names: Diagnosis of onchocerciasis

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Noguchi Memorial Institute for Medical Research

Other

Collaborators

  • Ghana Health Service, Neglected Tropical Diseases Program

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2017
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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