Malaria Surveillance in Rakai, Uganda
Condition: Malaria
MeSH terms: Malaria
Study type: Observational

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.
    

Detailed description: 
      Malaria is a leading cause of morbidity and mortality in Uganda, accounting for 25-40 percent
      of all outpatient visits at health facilities, 20 percent of hospital admissions, and 9-14
      percent of inpatient deaths. Malaria is meso- to holoendemic in Rakai, southwestern Uganda
      and children under 10 years, pregnant women and HIVinfected individuals bear the greatest
      burden of disease. Substantial progress has been made in malaria vaccine development and
      vaccine trials will be conducted over the coming years. The design of these trials will be
      contingent on understanding the epidemiology of malaria and disease burden in different
      epidemic settings.

      This study will determine the epidemiology of malaria infection in children and
      adolescents/adults by conducting surveillance in approximately 320 households selected from
      two of the 10 clusters under the Rakai Community Cohort Study (RCCS). Monthly visits will be
      made to randomly selected households during a one year surveillance period. Visit procedures
      include: structured interview/questionnaire of the primary care giver or legal guardian of
      the child; clinical and laboratory assessment of each child aged 6 months up to 10 years and
      the primary care giver; and clinical and laboratory assessment of one additional randomly
      selected adolescent/adult resident of the household. The study team will track usage of
      health clinic or hospital services within the district in order to link medical records for
      study participants. This community-based surveillance study will be linked to a separate
      facility-based surveillance study in health clinics/hospitals servicing the selected
      communities. This study will enhance the investigators understanding of the epidemiology of
      pediatric and adult malaria infection in Rakai district in preparation for future malaria
      vaccine trials. Investigators will be able to estimate the incidence of uncomplicated and
      severe malaria in children and adults. This protocol will also investigate the prevalence and
      association of sickle cell trait, xlinked glucose-6-phosphatase dehydrogenase deficiency and
      hemoglobinopathies (Hemoglobin C) and their associations with severe malaria among children
      and adults.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        1600 participants in approximately 320 households.@@@N=1700
      
Keywords: Children; Hemoglobinopathies; Epidemiology; Natural History; Malaria