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Introducing Rapid Diagnostic Tests Into the Private Health Sector

NCT ID: NCT01194557

Last Updated: 2012-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fever Malaria Diagnosis Referral

Keywords

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history of fever measured fever appropriate treatment appropriate referral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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rapid diagnostic test

Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests

Group Type ACTIVE_COMPARATOR

Rapid diagnostic test

Intervention Type DEVICE

Diagnosis of malaria using rapid diagnostic test

Lumartem

Intervention Type DRUG

Presumptive treatment of malaria/fever

Presumptive malaria treatment

Presumptive treatment for malaria in drug shops

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rapid diagnostic test

Diagnosis of malaria using rapid diagnostic test

Intervention Type DEVICE

Lumartem

Presumptive treatment of malaria/fever

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with fever
* uncomplicted malaria

Exclusion Criteria

* Complicated malaria
* known allergic reactions to Lumartem
Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Uganda

OTHER_GOV

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Artemisinin-based Combination Therapy

OTHER

Sponsor Role collaborator

DBL -Institute for Health Research and Development

OTHER

Sponsor Role lead

Responsible Party

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Pascal Magnussen

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony K Mbonye, PhD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Uganda

Locations

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Mukono District

Mukono, Mukono, Uganda

Site Status

Countries

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Uganda

References

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Chandler CI, Hall-Clifford R, Asaph T, Pascal M, Clarke S, Mbonye AK. Introducing malaria rapid diagnostic tests at registered drug shops in Uganda: limitations of diagnostic testing in the reality of diagnosis. Soc Sci Med. 2011 Mar;72(6):937-44. doi: 10.1016/j.socscimed.2011.01.009. Epub 2011 Feb 3.

Reference Type BACKGROUND
PMID: 21349623 (View on PubMed)

Mbonye AK, Ndyomugyenyi R, Turinde A, Magnussen P, Clarke S, Chandler C. The feasibility of introducing rapid diagnostic tests for malaria in drug shops in Uganda. Malar J. 2010 Dec 21;9:367. doi: 10.1186/1475-2875-9-367.

Reference Type BACKGROUND
PMID: 21176131 (View on PubMed)

Hutchinson E, Hutchison C, Lal S, Hansen K, Kayendeke M, Nabirye C, Magnussen P, Clarke SE, Mbonye A, Chandler CIR. Introducing rapid tests for malaria into the retail sector: what are the unintended consequences? BMJ Glob Health. 2017 Jan 11;2(1):e000067. doi: 10.1136/bmjgh-2016-000067. eCollection 2017.

Reference Type DERIVED
PMID: 28588992 (View on PubMed)

Mbonye AK, Magnussen P, Lal S, Hansen KS, Cundill B, Chandler C, Clarke SE. A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria. PLoS One. 2015 Jul 22;10(7):e0129545. doi: 10.1371/journal.pone.0129545. eCollection 2015.

Reference Type DERIVED
PMID: 26200467 (View on PubMed)

Mbonye AK, Magnussen P, Chandler CI, Hansen KS, Lal S, Cundill B, Lynch CA, Clarke SE. Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial. Trials. 2014 Jul 29;15:303. doi: 10.1186/1745-6215-15-303.

Reference Type DERIVED
PMID: 25069975 (View on PubMed)

Other Identifiers

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ACTUGA3

Identifier Type: -

Identifier Source: org_study_id