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CompletedNCT03131401Updated Oct 11, 2018

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

An observational study in Lymphatic Filariases and Onchocerciasis, sponsored by Noguchi Memorial Institute for Medical Research. Completed at 1 site in Ghana. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2018-10-11.

Sponsored by Noguchi Memorial Institute for Medical Research · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
3,736
Ages
5 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lymphatic Filariases
  • Onchocerciasis
03

Who can participate

Ages eligible
5 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Inability to come out of bed
  • Feeling sick
  • Inability to provide consent
04

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
3,736 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testDiagnosis of lymphatic filariasis

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

    Also known as: Filaria Test Strip, Wb123 RDT

  • Diagnostic testDiagnosis of lymphatic Filariasis and onchocerciasis

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

    Also known as: Wb123-Ov16 RDT

  • Diagnostic testDEC Patch

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

    Also known as: Diagnosis of onchocerciasis

05

What researchers measure

Primary outcomes

  1. Prevalence of lymphatic Filariasis

    To determine the prevalence and distribution of LF infection in three districts previously considered non-endemic but reporting LF cases

    Time frame: 3 months

  2. Measures of protection

    To determine what measures the population in these districts use to protect themselves from mosquito bites

    Time frame: 3 months

  3. Prevalence on Onchocerciasis

    To determine the prevalence and intensity of infection with O. volvulus in two of these three districts known to be onchocerciasis endemic

    Time frame: 3 months

  4. Vectors of lymphatic Filariasis

    To determine the LF vectors in three districts considered non-endemic for LF

    Time frame: 6 months

  5. Wuchereria bancrofti infection in vectors

    To assess the prevalence of W. bancrofti infection in mosquitoes in these districts.

    Time frame: 12 months

Secondary outcomes

  1. Performance of diagnostic tests

    To characterize the diagnostic performance via the standard parameters sensitivity and specificity of different diagnostic tests

    Time frame: 12 months

06

Study locations

1 site
  • Villages in Eastern and Volta Region
    Eastern And Volta Regions, Ghana
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03131401
Lead sponsor
Noguchi Memorial Institute for Medical Research
Collaborators
Ghana Health Service, Neglected Tropical Diseases Program
Responsible party
Sponsor
First posted
Apr 27, 2017
Start date
Jan 21, 2018
Primary completion
Aug 30, 2018
Completion
Aug 30, 2018
Last update
Oct 11, 2018

Study contacts

Daniel A Boakye, PhD
principal investigator · Noguchi Memorial Institute for Medical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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