Introducing Rapid Diagnostic Tests Into the Private Health Sector

NCT01194557 | Completed DMC

• 1 other identifier: ACTUGA3
• Study Type: interventional
• Target: 2,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Fever; Malaria; Diagnosis; Referral

Keywords

history of fever; measured fever; appropriate treatment; appropriate referral

Outcome Measures

Primary Outcomes (1)

• Appropriateness of treatment

  36 months

Secondary Outcomes (1)

• Appropriateness of referral of complicated malaria cases

  36 months

Study Arms (2)

rapid diagnostic test

ACTIVE COMPARATOR

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

Device: Rapid diagnostic test; Drug: Lumartem

Presumptive malaria treatment

NO INTERVENTION

Presumptive treatment for malaria in drug shops

Interventions

Rapid diagnostic test DEVICE

Diagnosis of malaria using rapid diagnostic test

rapid diagnostic test

Lumartem DRUG

Presumptive treatment of malaria/fever

rapid diagnostic test

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with fever
• uncomplicted malaria

You may not qualify if:

• Complicated malaria
• known allergic reactions to Lumartem

Sponsors & Collaborators

• DBL -Institute for Health Research and Development: lead
• Ministry of Health, Uganda: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Artemisinin-based Combination Therapy: collaborator

Study Sites (1)

Mukono District

Mukono, Mukono, Uganda

Location

Related Publications (5)

• 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.

  PMID: 21349623 BACKGROUND

• 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.

  PMID: 21176131 BACKGROUND

• 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.

  PMID: 28588992 DERIVED

• 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.

  PMID: 26200467 DERIVED

• 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.

  PMID: 25069975 DERIVED

MeSH Terms

Conditions

Fever; Malaria; Disease

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Anthony K Mbonye, PhD

  Ministry of Health, Uganda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 3, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 12, 2012

Record last verified: 2012-10

Locations

UG (1)