Malaria Surveillance in Rakai, Uganda

Malaria Clinical Trial

Official title:

Malaria Surveillance in Rakai, Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265407
• Other study ID #: 999911050
• Secondary ID: 11-I-N050
• Status: Completed
• Start date: December 22, 2010
• Est. completion date: July 23, 2013

Study information

• Verified date: September 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1650
• Est. completion date: July 23, 2013
• Est. primary completion date: September 12, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 99 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Malaria

Locations

Country	Name	City	State
Uganda	Rakai Health Sciences Program	Rakai

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Uganda, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Malaria rates (episodes/per year) in individuals and communities and by seasonality. Clinical episodes will be determined using RDT among febrile participants.	to estimate the proportion of participants from the household surveillance that seek care for malaria in health facilities	1 year
Secondary	Determine the rates of asymptomatic parasitemia among afebrileparticipants (determined by malaria smears and PCR).	to coordinate the community based surveillance with a facility based surveillance in health clinics servicing the selected communities	1 year
Secondary	The prevalence of enlarged palpable spleen (splenomegaly) in children	to investigate the prevalence of sickle cell trait,glucose-6 phosphate dehydrogenase deficiency and hemoglobinopathies and their relationship to severe clinical malaria per year in children and adults.	1 year