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

NCT03131401 | Completed

• 1 other identifier: TDR B40376
• Study Type: observational
• Target: 3,736
• Locations: 1 country
• Sites: 1

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. 1.determine whether LF intervention strategies are indicated in these three districts,
2. 2.design, as indicated, appropriate intervention strategies to achieve LF elimination in these three districts by 2020
3. 3.inform, if indicated, co-implementation of control, monitoring and evaluation for LF and onchocerciasis in the two onchocerciasis endemic districts
4. 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.

Conditions

Lymphatic Filariases; Onchocerciasis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Performance of diagnostic tests

  12 months

Interventions

Diagnosis of lymphatic filariasis DIAGNOSTIC_TEST

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

Also known as: 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.

Also known as: Wb123-Ov16 RDT

DEC Patch DIAGNOSTIC_TEST

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

Also known as: Diagnosis of onchocerciasis

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Noguchi Memorial Institute for Medical Research: lead
• Ghana Health Service, Neglected Tropical Diseases Program: collaborator

Study Sites (1)

Villages in Eastern and Volta Region

Eastern and Volta Regions, Ghana

Location

Biospecimen

Retention: SAMPLES WITH DNA

Only parasite positive blood specimen and DNA will be retained.

MeSH Terms

Conditions

Elephantiasis, Filarial; Onchocerciasis

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniel A Boakye, PhD

  Noguchi Memorial Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: April 27, 2017
• Study Start: January 21, 2018
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)