Malaria Surveillance in Rakai, Uganda

NCT01265407 | Completed

• 2 other identifiers: 99991105011-I-N050
• Study Type: observational
• Target: 1,650
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Malaria is a leading cause of morbidity and mortality in Uganda, accounting for more than a quarter of all outpatient visits at health facilities, 20 percent of hospital admissions, and about 10 percent of inpatient deaths. Children under 10 years of age, pregnant women, and HIV-infected individuals bear the greatest burden of disease. To provide baseline information for future malaria vaccine research, development, and testing, researchers are interested in collecting malaria infection data from the Rakai district in southern Uganda. Objectives: \- To assess the epidemiology of malaria infection among children aged 6 months to less than 10 years and adults living in same households with children in Rakai district, Uganda. Eligibility: \- Children between 6 months and 10 years of age, as well as their primary caregiver and an additional randomly selected adolescent or adult resident of the household, from the Rakai district of Uganda. Design:

• Participants will have monthly household visits for a 1-year surveillance period.
• Each visit will include a structured interview/questionnaire of the primary caregiver or legal guardian of the child and clinical and laboratory assessments of each child, the primary caregiver, and the additional adolescent or adult resident of the household. The questionnaire will ask about malaria treatment and prevention measures.
• Children will provide a blood sample for testing. Individuals (children or adults) who are diagnosed with malaria or anemia during the course of the study will be recommended for treatment.
• Researchers will also track usage of the district health clinic and hospital services to link medical records for study participants.

Conditions

Malaria

Keywords

Children; Hemoglobinopathies; Epidemiology; Natural History; Malaria

Outcome Measures

Primary Outcomes (1)

• Episodes of uncomplicated and severe clinical malaria per year in children and adults.

  to assess the epidemiology of malaria infection among children aged 6months-1year and adults living in the same household with children in Rakai district

  1 year

Secondary Outcomes (3)

• Malaria rates (episodes/per year) in individuals and communities and by seasonality. Clinical episodes will be determined using RDT among febrile participants.

  1 year

• Determine the rates of asymptomatic parasitemia among afebrileparticipants (determined by malaria smears and PCR).

  1 year

• The prevalence of enlarged palpable spleen (splenomegaly) in children

  1 year

Eligibility Criteria

• Age: 6 Months - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1600 participants in approximately 320 households.@@@N=1700

You may qualify if:

• Child aged 6 months to less than 10 years, primary care giver of an enrolled child, or an adolescent/adult resident in a household of an enrolled child.
• Willingness to participate in the study as evidenced by a completed and signed parental informed consent document and consent for child research participation (with assent of child/adolescent if appropriate).

You may not qualify if:

• Clinical evidence of an acute, life-threatening illness requiring immediate medical care at time of baseline household visit, not including severe malaria.
• Intent to stay in a study household for less than 12 months from the start of the study.
• School-going child in a boarding school who spends most of their time in a year at school rather than at home.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Rakai Health Sciences Program

Rakai, Uganda

Location

Related Publications (4)

• Hopkins H, Bebell L, Kambale W, Dokomajilar C, Rosenthal PJ, Dorsey G. Rapid diagnostic tests for malaria at sites of varying transmission intensity in Uganda. J Infect Dis. 2008 Feb 15;197(4):510-8. doi: 10.1086/526502.

  PMID: 18240951 BACKGROUND

• Jensen TP, Bukirwa H, Njama-Meya D, Francis D, Kamya MR, Rosenthal PJ, Dorsey G. Use of the slide positivity rate to estimate changes in malaria incidence in a cohort of Ugandan children. Malar J. 2009 Sep 15;8:213. doi: 10.1186/1475-2875-8-213.

  PMID: 19754955 BACKGROUND

• Pullan RL, Bukirwa H, Staedke SG, Snow RW, Brooker S. Plasmodium infection and its risk factors in eastern Uganda. Malar J. 2010 Jan 4;9:2. doi: 10.1186/1475-2875-9-2.

  PMID: 20044942 BACKGROUND

• Newell K, Kiggundu V, Ouma J, Baghendage E, Kiwanuka N, Gray R, Serwadda D, Hobbs CV, Healy SA, Quinn TC, Reynolds SJ. Longitudinal household surveillance for malaria in Rakai, Uganda. Malar J. 2016 Feb 9;15:77. doi: 10.1186/s12936-016-1128-6.

  PMID: 26861943 DERIVED

MeSH Terms

Conditions

Malaria; Hemoglobinopathies

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Steven J Reynolds, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 23, 2010
• Study Start: December 22, 2010
• Primary Completion: September 12, 2012
• Study Completion: July 23, 2013
• Last Updated: October 3, 2023

Record last verified: 2023-09

Locations

UG (1)