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Introducing Rapid Diagnostic Tests Into the Private Health Sector

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01194557
Enrollment
2600
Registered
2010-09-03
Start date
2010-09-30
Completion date
2012-07-31
Last updated
2012-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Malaria, Diagnosis, Referral

Keywords

history of fever, measured fever, appropriate treatment, appropriate referral

Brief summary

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.

Interventions

DRUGLumartem

Presumptive treatment of malaria/fever

Diagnosis of malaria using rapid diagnostic test

Sponsors

Ministry of Health, Uganda
CollaboratorOTHER_GOV
London School of Hygiene and Tropical Medicine
CollaboratorOTHER
Artemisinin-based Combination Therapy
CollaboratorOTHER
DBL -Institute for Health Research and Development
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with fever * uncomplicted malaria

Exclusion criteria

* Complicated malaria * known allergic reactions to Lumartem

Design outcomes

Primary

MeasureTime frame
Appropriateness of treatment36 months

Secondary

MeasureTime frame
Appropriateness of referral of complicated malaria cases36 months

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026