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临床试验/NCT03131401
NCT03131401已完成不适用

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

Noguchi Memorial Institute for Medical Research1 个研究点 分布在 1 个国家目标入组 3,736 人开始时间: 2018年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,736
试验地点
1
主要终点
Prevalence of lymphatic Filariasis

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Prevalence of lymphatic Filariasis

时间窗: 3 months

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

Measures of protection

时间窗: 3 months

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

Wuchereria bancrofti infection in vectors

时间窗: 12 months

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

Prevalence on Onchocerciasis

时间窗: 3 months

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

Vectors of lymphatic Filariasis

时间窗: 6 months

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

次要结局

  • Performance of diagnostic tests(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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