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

Onchocerciasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131401
• Other study ID #: TDR B40376
• Status: Completed
• Start date: January 21, 2018
• Est. completion date: August 30, 2018

Study information

• Verified date: October 2018
• Source: Noguchi Memorial Institute for Medical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3736
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Filariasis
• Lymphatic Filariases
• Onchocerciasis

Intervention

Diagnostic Test:
• Diagnosis of lymphatic filariasis
Field validation of the diagnostic performance of diagnostic tests for infection with W. bancrofti.
• Diagnosis of lymphatic Filariasis and onchocerciasis
Field validation of the diagnostic performance of diagnostic tests for infection with both W. bancrofti and O. volvulus.
• DEC Patch
Field validation of the diagnostic performance of diagnostic tests for infection with O. volvulus.

Locations

Country	Name	City	State
Ghana	Villages in Eastern and Volta Region	Eastern And Volta Regions

Sponsors (2)

Lead Sponsor	Collaborator
Noguchi Memorial Institute for Medical Research	Ghana Health Service, Neglected Tropical Diseases Program

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of lymphatic Filariasis	To determine the prevalence and distribution of LF infection in three districts previously considered non-endemic but reporting LF cases	3 months
Primary	Measures of protection	To determine what measures the population in these districts use to protect themselves from mosquito bites	3 months
Primary	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	3 months
Primary	Vectors of lymphatic Filariasis	To determine the LF vectors in three districts considered non-endemic for LF	6 months
Primary	Wuchereria bancrofti infection in vectors	To assess the prevalence of W. bancrofti infection in mosquitoes in these districts.	12 months
Secondary	Performance of diagnostic tests	To characterize the diagnostic performance via the standard parameters sensitivity and specificity of different diagnostic tests	12 months