MalariaNCT01062386
Malaria Survey in Mbarara District, Uganda 2010
An observational study of Malaria, run by Epicentre at 1 site in Uganda.
Trial summary
Malaria is one of the major public health problems in Sub-Saharan Africa. In response to this threat, Roll Back Malaria (RBM) has rolled back a strategy using ACT as first line therapy for malaria episode, a wide distribution of Insecticide Treated Bednet (ITN), intermittent presumptive treatment of pregnant women and… Read more about this study
- Who is it for?
- Ages 1 month to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 2,320 participants
- Where
- 1 siteUganda
- Study dates
- Jan 2010to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children living in Great Mbarara district
Who may be able to join
- Males and females
- Ages 1 month to 59 months
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Epidemiology of Malaria Among Children Under Five in Mbarara District, Uganda - A Cross-sectional Population-based Survey 2010
Malaria is one of the major public health problems in Sub-Saharan Africa. In response to this threat, Roll Back Malaria (RBM) has rolled back a strategy using ACT as first line therapy for malaria episode, a wide distribution of Insecticide Treated Bednet (ITN), intermittent presumptive treatment of pregnant women and indoor residual spraying. Recent epidemiological observations suggested a decline in malaria prevalence in some countries but further evidences are still needed to confirm this evolution. The RBM strategy requires the use of reliable rapid diagnostic test (RDT) for which an operational assessment is necessary. Lastly, home-based management of malaria is also an important compound of this strategy. However, a better understanding of the actual use of antimalarial drugs, of the use of bednet and of the barrier to the use of health care is important to implement good quality strategies for malaria control.
This study is a cross-sectional community based survey made of two rounds (one in January 2010 and the second in June 2010). The general objective is to measure the prevalence of infection with Plasmodium falciparum at two periods of the year (at the moment of lowest and highest transmission based on the seasonal rainfalls) and to compare it with the prevalence estimated in 2004 after the rainy season for the same area. Specific objective are the estimation of the prevalence by age stratum, the analysis of the geographical distribution of the infection, the description of the parasitological characteristics, the assessment of three RDT, the description and the analysis of the prevention and care seek behaviours related to malaria.
The study area is the great Mbarara district located in south-west of Uganda. A three-stage cluster sampling method will be used. Spatial information will be collected with global positioning system and imported to Geographical Information System. Behaviour information will be collected through face to face interview.
- Conditions
- Malaria
- Keywords
- prevalence, transmission, knowledge, attitude, practice
- Medical subject headings
- Malaria, Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of malaria infections in children under 5 years of age
Measured: January-February 2010
Secondary outcomes (1)
Proportion of families with knowledge, attitude and practice regarding malaria prevention
Measured: January-February 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Investigators
- Carolyn Nabasumba, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062386
- Sponsor's protocol ID
- Epicentre/Mba/2010/MalPrev
- Status last verified
- Aug 2011
- First submitted
- 3 Feb 2010
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology of Malaria Among Children Under Five in Mbarara District, Uganda - A Cross-sectional Population-based Survey 2010
- ClinicalTrials.gov ID
- NCT01062386
- Acronym / sponsor ID
- Epicentre/Mba/2010/MalPrev
- Conditions
- Malaria
- Keywords
- prevalence, transmission, knowledge, attitude, practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,320 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Study start
- Jan 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malaria is one of the major public health problems in Sub-Saharan Africa. In response to this threat, Roll Back Malaria (RBM) has rolled back a strategy using ACT as first line therapy for malaria episode, a wide distribution of Insecticide Treated Bednet (ITN), intermittent presumptive treatment of pregnant women and indoor residual spraying. Recent epidemiological observations suggested a decline in malaria prevalence in some countries but further evidences are still needed to confirm this evolution. The RBM strategy requires the use of reliable rapid diagnostic test (RDT) for which an operational assessment is necessary. Lastly, home-based management of malaria is also an important compound of this strategy. However, a better understanding of the actual use of antimalarial drugs, of the use of bednet and of the barrier to the use of health care is important to implement good quality strategies for malaria control.
This study is a cross-sectional community based survey made of two rounds (one in January 2010 and the second in June 2010). The general objective is to measure the prevalence of infection with Plasmodium falciparum at two periods of the year (at the moment of lowest and highest transmission based on the seasonal rainfalls) and to compare it with the prevalence estimated in 2004 after the rainy season for the same area. Specific objective are the estimation of the prevalence by age stratum, the analysis of the geographical distribution of the infection, the description of the parasitological characteristics, the assessment of three RDT, the description and the analysis of the prevention and care seek behaviours related to malaria.
The study area is the great Mbarara district located in south-west of Uganda. A three-stage cluster sampling method will be used. Spatial information will be collected with global positioning system and imported to Geographical Information System. Behaviour information will be collected through face to face interview.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children living in Great Mbarara district
Key inclusion criteria (2 listed)
- Males and females
- Ages 1 month to 59 months
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of malaria infections in children under 5 years of age
Time frame: January-February 2010
1 secondary outcome
Proportion of families with knowledge, attitude and practice regarding malaria prevention
Time frame: January-February 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Nabasumba principal investigator
Epicentre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Epicentre at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of malaria infections in children under 5 years of age (time frame: January-February 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2011; AzTrials last refreshed its copy on 5 Nov 2026.