Introducing Rapid Diagnostic Tests Into the Private Health Sector
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Purpose
Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, artemisinin combination therapies (ACTs) should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff.
This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by ocal drug shops in an area with high malaria transmission.
| Condition | Intervention |
|---|---|
|
Fever Malaria Diagnosis Referral |
Device: Rapid diagnostic test Drug: Lumartem |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Introducing Rapid Diagnostic Tests Into the Private Health Sector in Uganda: a Randomised Trial Among Registered Drug Shops to Evaluate Impact on Antimalarial Drug Use |
- Appropriateness of treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Appropriateness of referral of complicated malaria cases [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Enrollment: | 2600 |
| Study Start Date: | September 2010 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: rapid diagnostic test
Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests
|
Device: Rapid diagnostic test
Diagnosis of malaria using rapid diagnostic test
Drug: Lumartem
Presumptive treatment of malaria/fever
|
|
No Intervention: Presumptive malaria treatment
Presumptive treatment for malaria in drug shops
|
Eligibility| Ages Eligible for Study: | 1 Month and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with fever
- uncomplicted malaria
Exclusion Criteria:
- Complicated malaria
- known allergic reactions to Lumartem
Contacts and Locations| Uganda | |
| Mukono District | |
| Mukono, Uganda | |
| Principal Investigator: | Anthony K Mbonye, PhD | Ministry of Health, Uganda |
More Information
Publications:
| Responsible Party: | Pascal Magnussen, Senior Researcher, DBL -Institute for Health Research and Development |
| ClinicalTrials.gov Identifier: | NCT01194557 History of Changes |
| Other Study ID Numbers: | ACTUGA3 |
| Study First Received: | September 2, 2010 |
| Last Updated: | October 11, 2012 |
| Health Authority: | United Kingdom: National Health Services |
Keywords provided by DBL -Institute for Health Research and Development:
|
history of fever measured fever appropriate treatment appropriate referral |
Additional relevant MeSH terms:
|
Fever Malaria Body Temperature Changes Signs and Symptoms Protozoan Infections Parasitic Diseases |
Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013