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

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.

Study Overview

• Status: Completed
• Conditions: Fever; Malaria; Diagnosis; Referral
• Intervention / Treatment: Device: Rapid diagnostic test; Drug: Lumartem

• Study Type: Interventional
• Enrollment (Actual): 2600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Mukono, Uganda
    • Mukono District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with fever
• uncomplicted malaria

Exclusion Criteria:

• Complicated malaria
• known allergic reactions to Lumartem

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: rapid diagnostic test; Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests	Device: Rapid diagnostic test; Diagnosis of malaria using rapid diagnostic test; Drug: Lumartem; Presumptive treatment of malaria/fever
NO_INTERVENTION: Presumptive malaria treatment; Presumptive treatment for malaria in drug shops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Appropriateness of treatment	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Appropriateness of referral of complicated malaria cases	36 months

Collaborators and Investigators

• Sponsor: DBL -Institute for Health Research and Development
• Collaborators: London School of Hygiene and Tropical Medicine; Ministry of Health, Uganda; Artemisinin-based Combination Therapy
• Investigators: Principal Investigator: Anthony K Mbonye, PhD, Ministry of Health, Uganda

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: September 2, 2010
• First Posted (ESTIMATE): September 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 12, 2012
• Last Update Submitted That Met QC Criteria: October 11, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: history of fever; measured fever; appropriate treatment; appropriate referral
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Body Temperature Changes; Malaria; Fever
• Other Study ID Numbers: ACTUGA3