Malaria Surveillance in Rakai, Uganda
Keywords
Abstract
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.
Dates
Last Verified: | 01/27/2020 |
First Submitted: | 12/21/2010 |
Estimated Enrollment Submitted: | 12/21/2010 |
First Posted: | 12/22/2010 |
Last Update Submitted: | 08/10/2020 |
Last Update Posted: | 08/11/2020 |
Actual Study Start Date: | 12/21/2010 |
Condition or disease
Phase
Eligibility Criteria
Ages Eligible for Study | 6 Months To 6 Months |
Sexes Eligible for Study | All |
Sampling method | Probability Sample |
Accepts Healthy Volunteers | Yes |
Criteria | - INCLUSION CRITERIA: 1. 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. 2. 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). EXCLUSION CRITERIA: 1. Clinical evidence of an acute, life-threatening illness requiring immediate medical care at time of baseline household visit, not including severe malaria. 2. Intent to stay in a study household for less than 12 months from the start of the study. 3. School-going child in a boarding school who spends most of their time in a year at school rather than at home. |
Outcome
Primary Outcome Measures
1. Episodes of uncomplicated and severe clinical malaria per year in children and adults. [1 year]
Secondary Outcome Measures
1. Malaria rates (episodes/per year) in individuals and communities and by seasonality. Clinical episodes will be determined using RDT among febrile participants. [1 year]
2. Determine the rates of asymptomatic parasitemia among afebrileparticipants (determined by malaria smears and PCR). [1 year]
3. The prevalence of enlarged palpable spleen (splenomegaly) in children [1 year]