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

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

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.

Study Overview

• Status: Completed
• Conditions: Onchocerciasis; Lymphatic Filariases
• Intervention / Treatment: Diagnostic test: Diagnosis of lymphatic filariasis; Diagnostic test: Diagnosis of lymphatic Filariasis and onchocerciasis; Diagnostic test: DEC Patch

• Study Type: Observational
• Enrollment (Actual): 3736

Contacts and Locations

Study Locations

• Ghana
  • Eastern And Volta Regions, Ghana
    • Villages in Eastern and Volta Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Measures of protection	To determine what measures the population in these districts use to protect themselves from mosquito bites	3 months
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
Vectors of lymphatic Filariasis	To determine the LF vectors in three districts considered non-endemic for LF	6 months
Wuchereria bancrofti infection in vectors	To assess the prevalence of W. bancrofti infection in mosquitoes in these districts.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of diagnostic tests	To characterize the diagnostic performance via the standard parameters sensitivity and specificity of different diagnostic tests	12 months

Collaborators and Investigators

• Sponsor: Noguchi Memorial Institute for Medical Research
• Collaborators: Ghana Health Service, Neglected Tropical Diseases Program
• Investigators: Principal Investigator: Daniel A Boakye, PhD, Noguchi Memorial Institute for Medical Research

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2018
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Lymphatic Diseases; Vector Borne Diseases; Parasitic Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Lymphedema; Filariasis; Elephantiasis, Filarial; Elephantiasis; Onchocerciasis
• Other Study ID Numbers: TDR B40376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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