Introducing Rapid Diagnostic Tests Into the Private Health Sector

This study has been completed.

Sponsor:

Collaborators:

Ministry of Health, Uganda

London School of Hygiene and Tropical Medicine

Artemisinin based combination Therapies Consortium

Information provided by (Responsible Party):

Pascal Magnussen, DBL -Institute for Health Research and Development

ClinicalTrials.gov Identifier:

NCT01194557

First received: September 2, 2010

Last updated: October 11, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 2, 2010

Last Updated Date

October 11, 2012

Start Date ^ICMJE

September 2010

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Appropriateness of treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01194557 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Appropriateness of referral of complicated malaria cases [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Introducing Rapid Diagnostic Tests Into the Private Health Sector

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Fever
Malaria
Diagnosis
Referral

Intervention ^ICMJE

Device: Rapid diagnostic test
Diagnosis of malaria using rapid diagnostic test
Drug: Lumartem
Presumptive treatment of malaria/fever

Study Arm (s)

Active Comparator: rapid diagnostic test
Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests
Interventions:
- Device: Rapid diagnostic test
- Drug: Lumartem
No Intervention: Presumptive malaria treatment
Presumptive treatment for malaria in drug shops

Publications *

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. Malaria Journal 2010, 9:367
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. Epub 2011 Feb 3.
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2600

Completion Date

July 2012

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with fever
uncomplicted malaria

Exclusion Criteria:

Complicated malaria
known allergic reactions to Lumartem

Gender

Both

Ages

1 Month and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Uganda

Administrative Information

NCT Number ^ICMJE

NCT01194557

Other Study ID Numbers ^ICMJE

ACTUGA3

Has Data Monitoring Committee

Yes

Responsible Party

Pascal Magnussen, DBL -Institute for Health Research and Development

Study Sponsor ^ICMJE

DBL -Institute for Health Research and Development

Collaborators ^ICMJE

Ministry of Health, Uganda
London School of Hygiene and Tropical Medicine
Artemisinin based combination Therapies Consortium

Investigators ^ICMJE

Principal Investigator:

Anthony K Mbonye, PhD

Ministry of Health, Uganda

Information Provided By

DBL -Institute for Health Research and Development

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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