MalariaNCT00716599
Training in Fever Case Management With Rapid Diagnostic Tests (RDTs) for Malaria in Uganda
A study testing training in use of rapid diagnostic tests (RDTs) for malaria in people with Malaria and Fever, run by University of California, San Francisco at 1 site in Uganda.
Trial summary
Malaria remains one of the most devastating infectious diseases in the world. Despite the potential for serious adverse outcomes with each episode of malaria, most cases in endemic areas are diagnosed on clinical grounds alone. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- training in use of rapid diagnostic tests (RDTs) for malaria
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,000 participants
- Where
- 1 siteUganda
- Study dates
- Jan 2008to Jul 2008
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all outpatients at participating health centers
Who cannot join
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Training in Fever Case Management Incorporating Rapid Diagnostic Tests (RDTs) for Malaria at Peripheral Health Centers in Uganda
Malaria remains one of the most devastating infectious diseases in the world. Despite the potential for serious adverse outcomes with each episode of malaria, most cases in endemic areas are diagnosed on clinical grounds alone. Even the simple technique of light microscopy, the gold standard for malaria diagnosis, is inaccessible to most individuals in resource-poor malarious areas. New diagnostic methods that are practical for limited health-care settings are urgently needed. Immunochromatographic rapid diagnostic tests (RDTs) for malaria are easy to use, require little infrastructure or expertise, show good accuracy, and are increasingly advocated for routine use in malaria-endemic areas. A major challenge now is to implement RDTs effectively in typical African clinical settings. We plan to evaluate the clinical effectiveness and safety of a training curriculum incorporating RDT use in peripheral government health centers in Uganda. Results from this study will provide evidence for scale-up of RDT implementation in Uganda, as planned by the Uganda Ministry of Health from mid-2008, as well as in other sub-Saharan African countries.
The aim of this study is to evaluate the clinical effectiveness and safety of a basic training program incorporating RDTs, as compared with standard-of-care presumptive treatment, for the management of patients who present with suspected malaria at peripheral health centers in Uganda. Our hypothesis is that training in fever case management and RDT use will allow health center staff to reduce unnecessary antimalarial prescriptions without compromising patient outcomes, compared with the current practice of presumptive antimalarial therapy for all febrile patients.
- Being tested
- training in use of rapid diagnostic tests (RDTs) for malaria
- Keywords
- malaria, diagnosis, rapid diagnostic test, rapid diagnostic tests, fever case management, training, fever case management in malaria-endemic areas
- Medical subject headings
- Malaria, Fever, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training in use of rapid diagnostic tests (RDTs) for malariaDevice
training program and introduction of RDTs for use in case management of patients presenting for routine care at government health centers
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Health centers continue with standard-of-care empiric case management |
| RDT training | Experimental | Health centers randomly selected to receive training and RDTs, for use in routine patient case management Receives: Device: training in use of rapid diagnostic tests (RDTs) for malaria |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare changes in the proportion of patients prescribed any antimalarial therapy between health centers with and without an RDT training intervention.
Measured: point of care
Secondary outcomes (1)
To compare changes in the proportion of patients with an inadequate response to initial therapy between health centers with and without an RDT training intervention.
Measured: 5 days after initial clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJul 2008
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.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Exxon Mobil, Makerere University, Uganda Malaria Surveillance Project, National Institutes of Health (NIH), Doris Duke Charitable Foundation
- Investigators
- Heidi Hopkins, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716599
- Sponsor's protocol ID
- EM-036
- Status last verified
- Jul 2008
- First submitted
- 14 Jul 2008
- Last updated
- 16 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Training in Fever Case Management Incorporating Rapid Diagnostic Tests (RDTs) for Malaria at Peripheral Health Centers in Uganda
- ClinicalTrials.gov ID
- NCT00716599
- Acronym / sponsor ID
- EM-036
- Keywords
- malaria, diagnosis, rapid diagnostic test, rapid diagnostic tests, fever case management, training, fever case management in malaria-endemic areas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,000 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Exxon Mobil, Makerere University, Uganda Malaria Surveillance Project, National Institutes of Health (NIH), Doris Duke Charitable Foundation
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Jul 2008 (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 remains one of the most devastating infectious diseases in the world. Despite the potential for serious adverse outcomes with each episode of malaria, most cases in endemic areas are diagnosed on clinical grounds alone. Even the simple technique of light microscopy, the gold standard for malaria diagnosis, is inaccessible to most individuals in resource-poor malarious areas. New diagnostic methods that are practical for limited health-care settings are urgently needed. Immunochromatographic rapid diagnostic tests (RDTs) for malaria are easy to use, require little infrastructure or expertise, show good accuracy, and are increasingly advocated for routine use in malaria-endemic areas. A major challenge now is to implement RDTs effectively in typical African clinical settings. We plan to evaluate the clinical effectiveness and safety of a training curriculum incorporating RDT use in peripheral government health centers in Uganda. Results from this study will provide evidence for scale-up of RDT implementation in Uganda, as planned by the Uganda Ministry of Health from mid-2008, as well as in other sub-Saharan African countries.
The aim of this study is to evaluate the clinical effectiveness and safety of a basic training program incorporating RDTs, as compared with standard-of-care presumptive treatment, for the management of patients who present with suspected malaria at peripheral health centers in Uganda. Our hypothesis is that training in fever case management and RDT use will allow health center staff to reduce unnecessary antimalarial prescriptions without compromising patient outcomes, compared with the current practice of presumptive antimalarial therapy for all febrile patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Health centers continue with standard-of-care empiric case management |
| RDT training | Experimental | Device: training in use of rapid diagnostic tests (RDTs) for malariaHealth centers randomly selected to receive training and RDTs, for use in routine patient case management |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all outpatients at participating health centers
Key exclusion criteria (1 listed)
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| training in use of rapid diagnostic tests (RDTs) for malariatraining program and introduction of RDTs for use in case management of patients presenting for routine care at government health centers | Device | RDT training |
Primary outcome
To compare changes in the proportion of patients prescribed any antimalarial therapy between health centers with and without an RDT training intervention.
Time frame: point of care
1 secondary outcome
To compare changes in the proportion of patients with an inadequate response to initial therapy between health centers with and without an RDT training intervention.
Time frame: 5 days after initial clinic visit
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 16 Jul 2008.
- research collaboration websiteLink provided by the sponsor.
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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.
Heidi Hopkins, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training in use of rapid diagnostic tests (RDTs) for malaria in people with Malaria and Fever, run by University of California, San Francisco 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 1 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 16 Jul 2008. 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?
To compare changes in the proportion of patients prescribed any antimalarial therapy between health centers with and without an RDT training intervention. (time frame: point of care). 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 16 Jul 2008.