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Introducing Rapid Diagnostic Tests Into the Private Health Sector

Primary Purpose

Fever, Malaria, Diagnosis

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Rapid diagnostic test
Lumartem
Sponsored by
DBL -Institute for Health Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fever focused on measuring history of fever, measured fever, appropriate treatment, appropriate referral

Eligibility Criteria

1 Month - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with fever
  • uncomplicted malaria

Exclusion Criteria:

  • Complicated malaria
  • known allergic reactions to Lumartem

Sites / Locations

  • Mukono District

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

rapid diagnostic test

Presumptive malaria treatment

Arm Description

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

Presumptive treatment for malaria in drug shops

Outcomes

Primary Outcome Measures

Appropriateness of treatment

Secondary Outcome Measures

Appropriateness of referral of complicated malaria cases

Full Information

First Posted
September 2, 2010
Last Updated
October 11, 2012
Sponsor
DBL -Institute for Health Research and Development
Collaborators
Ministry of Health, Uganda, London School of Hygiene and Tropical Medicine, Artemisinin-based Combination Therapy
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1. Study Identification

Unique Protocol Identification Number
NCT01194557
Brief Title
Introducing Rapid Diagnostic Tests Into the Private Health Sector
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DBL -Institute for Health Research and Development
Collaborators
Ministry of Health, Uganda, London School of Hygiene and Tropical Medicine, Artemisinin-based Combination Therapy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Malaria, Diagnosis, Referral
Keywords
history of fever, measured fever, appropriate treatment, appropriate referral

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rapid diagnostic test
Arm Type
Active Comparator
Arm Description
Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests
Arm Title
Presumptive malaria treatment
Arm Type
No Intervention
Arm Description
Presumptive treatment for malaria in drug shops
Intervention Type
Device
Intervention Name(s)
Rapid diagnostic test
Intervention Description
Diagnosis of malaria using rapid diagnostic test
Intervention Type
Drug
Intervention Name(s)
Lumartem
Intervention Description
Presumptive treatment of malaria/fever
Primary Outcome Measure Information:
Title
Appropriateness of treatment
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Appropriateness of referral of complicated malaria cases
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with fever uncomplicted malaria Exclusion Criteria: Complicated malaria known allergic reactions to Lumartem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony K Mbonye, PhD
Organizational Affiliation
Ministry of Health, Uganda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mukono District
City
Mukono
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
21349623
Citation
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.
Results Reference
background
PubMed Identifier
21176131
Citation
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.
Results Reference
background
PubMed Identifier
28588992
Citation
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.
Results Reference
derived
PubMed Identifier
26200467
Citation
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.
Results Reference
derived
PubMed Identifier
25069975
Citation
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.
Results Reference
derived

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Introducing Rapid Diagnostic Tests Into the Private Health Sector

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