RVF and Other Emerging Infectious Diseases in East and Central Africa

NCT05139524 | Unknown

• 1 other identifier: KEMRI/SERU/CGHR/356/4169
• Study Type: observational
• Target: 5,000
• Locations: 4 countries
• Sites: 10

Brief Summary

Rift Valley fever (RVF), a disease transmitted from livestock (cattle, sheep, goats, camels) to humans more commonly occurs in the East and Central Africa (ECA) regions where more than 15 major epidemics affecting more than one country have been reported over the past 50 years. Within the region, there are specific areas, referred to as hotspots, which support RVF virus maintenance via low-level virus circulation between animals, humans, and mosquitoes. Most outbreaks originate from these hotspots. Our goal is to conduct studies in RVF hotspots in four ECA countries, Kenya, Uganda, Tanzania, and Democratic Republic of Congo (DRC) to determine the burden of RVF disease among humans, wildlife and livestock during inter-epidemic periods (IEPs) and discover circulation of undetected infectious diseases. This information is important for use in developing an early warning system and possibly a vaccination strategy. The study will take place in Uganda, Kenya, Tanzania and Democratic Republic of Congo

Conditions

Rift Valley Fever; Hemorrhagic Fevers, Viral

Keywords

surveillance; emerging infectious disease

Outcome Measures

Primary Outcomes (1)

• Detection of RVF virus exposure

  Detection of RVFV RNA, and IgM and IgG antibodies

  2 years

Study Arms (2)

Health facility based cohort

Cohort of individuals with acute or reported fever enrolled at health facilities and followed up for upto 24 months.

Other: Evidence of past or recent RVF exposure

Community survey

Individuals enrolled in study as part of a cross sectional survey in the community.

Other: Evidence of past or recent RVF exposure

Interventions

Evidence of past or recent RVF exposure OTHER

Detection of RVF exposure.

Also known as: RVFV RNA and IgM and IgG antibodies

Community survey; Health facility based cohort

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For health facility based study: Patients attending enrolled health facilities in study areas i.e. North and South Kivu (DRC), Isingiro, Rubanda and Kabale districts (Uganda), Muranga, Isiolo, Tana River and Marsabit counties (Kenya) and Iringa district (Tanzania). For community cross sectional survey: Residents of households in study areas i.e. North and South Kivu (DRC), Isingiro, Rubanda and Kabale districts (Uganda), Muranga, Isiolo, Tana River and Marsabit counties (Kenya) and Iringa district (Tanzania).

You may qualify if:

• Persons ≥ 10 years of age who are malaria negative AND have undifferentiated acute fever at the time of presentation (≥ 37.5°C) or reported fever in the past 4 weeks.
• Persons ≥ 10 years of age who are malaria positive AND have undifferentiated acute fever at the time of presentation (≥ 37.5°C) or reported fever in the past 4 weeks.
• Category C: All patients at the health facility meeting these criteria will be enrolled in the study
• Persons ≥ 10 years of age with:
• Unexplained bleeding with or without fever manifesting as either: Blood in vomitus, Bleeding from the gums, Bleeding from the nose, Bleeding in the eyes (red eyes), Non-menstrual genital bleeding, Bleeding from any other body site OR
• Infectious disease illness of unknown etiology requiring hospitalization. The illness should not be responding to antimalarials and/or antibiotics following 7 days of treatment
• Member of household 2 or more years of age.

You may not qualify if:

• Those who do not consent or refuse written consent. If a participant is severely ill and has no next of kin to provide consent +/- witness on their behalf.
• If a participant is known to have blood clotting disorders, allergies arising from injections, or if a participant has ever fainted during previous injections or blood collection

Sponsors & Collaborators

• Washington State University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Emory University: collaborator
• Washington University School of Medicine: collaborator
• Kenya Medical Research Institute: collaborator
• University of Nairobi: collaborator
• The International Livestock Research Institute (ILRI): collaborator
• MRC/UVRI and LSHTM Uganda Research Unit: collaborator
• Sokoine University of Agriculture: collaborator
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• Institute of Tropical Medicine, Belgium: collaborator
• Charite University, Berlin, Germany: collaborator
• Kenya Ministry of Health: collaborator
• Ministry of Agriculture Livestock Fisheries and Cooperatives, Kenya: collaborator
• Ministry of Agriculture, Animal Industry and Fisheries, Uganda: collaborator
• Ministry of Health, Uganda: collaborator
• Ministry of Public Health, Democratic Republic of the Congo: collaborator
• Ministry of Agriculture, Fisheries and Livestock, Democratic Republic of Congo: collaborator

Study Sites (10)

Virunga Hospital & North Kivu

Goma, North Kivu, Democratic Republic of the Congo

RECRUITING

South Kivu

Bukavu, Democratic Republic of the Congo

NOT YET RECRUITING

Tana River County

Hola, Kenya

NOT YET RECRUITING

Isiolo county

Isiolo, Kenya

NOT YET RECRUITING

Marsabit county

Marsabit, Kenya

NOT YET RECRUITING

Muranga county

Murang’a, Kenya

NOT YET RECRUITING

Iringa

Iringa, Tanzania

NOT YET RECRUITING

Rwekubbo health centre IV & Isingiro district

Isingiro, Uganda

RECRUITING

Kabale Regional Referral Hospital & Kabale district

Kabale, Uganda

RECRUITING

Rwekubo Health Centre IV & Rubanda district

Rubanda, Uganda

RECRUITING

Related Links

• Link to the research center conducting the research

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Rift Valley Fever; Hemorrhagic Fevers, Viral; Communicable Diseases, Emerging

Interventions

Immunoglobulin M

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Animal; Hepatitis, Animal; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Virus Diseases; Bunyaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Animal Diseases; Communicable Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• M. Kariuki Njenga, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanette A Dawa, PhD

CONTACT

+254750653696; jeanette.dawa@wsu.edu

M. Kariuki Njenga, PhD

CONTACT

+254700354441; mkariuki.njenga@wsu.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: October 8, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); KE (4); UG (3); TA (1)