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Rift Valley Fever in Kenya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287014
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : August 27, 2010
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this study is to find out how, why, and when Rift Valley Fever (RVF) spreads. Participants will be 250 adults and children, aged 1 year and older, from the Ijara District, Kenya. They will be given a questionnaire, undergo a medical examination that includes an eye exam, and have a 1-teaspoon sample of blood taken from a vein. Participation will take about 3 hours.

Condition or disease
Rift Valley Fever

Detailed Description:
The objective of this research is to better define the extent and timing of Rift Valley Fever (RVF) virus transmission and its related chronic disease/infection attack rate, during an interepidemic period in a high-risk region that has seen repeated RVF outbreaks. The results will be used to develop and refine predictive algorithms for RVF Virus transmission, based on epidemiological, environmental, and remote sensing data, with the ultimate goal of providing improved early detection of significant RVF outbreaks. It is expected that the analysis of test-performance characteristics will determine the best use of serologic assays in Kenya's next RVF epizootic/epidemic. The primary outcome measure will be the current RVF-specific seropositivity profile for a cross-sectional survey population in Ijara District in northeast Kenya. The secondary outcome measures to be studied will be: 1) an assessment of the behavioral factors associated with risk of seropositivity (previous infection) in the study population; and 2) the association of selected long-term ophthalmological and clinical outcomes with seropositivity. The study design for this protocol involves questionnaire administration to consenting participants of Ijara District, followed by performance of medical exams, ophthalmologic exams, and phlebotomy on all participants. ELISA testing for RVF will then be performed on the blood samples obtained, and all ELISA screen-positive samples will have confirmatory testing by plaque-reduction neutralizing antibody testing.

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Study Type : Observational
Enrollment : 250 participants
Time Perspective: Prospective
Official Title: Late Outcomes of Rift Valley Fever in Kenya: Ijara Clinical Survey
Study Start Date : March 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Valley Fever

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Those adults and children residing in selected survey households in the area of Ijara Town and its 5 km environs who are 1 year of age and older will be eligible, provided:

  1. Informed consent is obtained and signed, and assent form is obtained and signed from children age 7 and older,
  2. Subject has understanding of study procedures, and
  3. Subject is able to comply with study procedures for the entire length of the study.

Exclusion Criteria:

  1. Age less than 1 year.
  2. Subjects who immigrated to the study area less than 2 years previously.
  3. Acutely ill Ijara residents.
  4. Adults and children who cannot provide informed consent or who cannot participate fully in the study procedures will also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00287014

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Ijara District
Ijara, Kenya
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Layout table for additonal information Identifier: NCT00287014    
Other Study ID Numbers: 05-0042
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: October 2007
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Rift valley fever, Kenya
Additional relevant MeSH terms:
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Rift Valley Fever
Body Temperature Changes
Protozoan Infections
Parasitic Diseases
Arbovirus Infections
Virus Diseases
Hepatitis, Viral, Animal
Bunyaviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Hepatitis, Animal
Liver Diseases
Digestive System Diseases