Rift Valley Fever in Kenya
| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 2, 2006 |
| Last Updated Date | August 26, 2010 |
| Start Date ICMJE | March 2006 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00287014 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Rift Valley Fever in Kenya |
| Official Title ICMJE | Late Outcomes of Rift Valley Fever in Kenya: Ijara Clinical Survey |
| 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. |
| 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. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Not Provided |
| Study Population | Not Provided |
| Condition ICMJE | Rift Valley Fever |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 250 |
| Completion Date | April 2006 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | 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:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 1 Year and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Kenya |
| Administrative Information | |
| NCT Number ICMJE | NCT00287014 |
| Other Study ID Numbers ICMJE | 05-0042 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) |
| Verification Date | October 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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