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Open Access Research

Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial

Anthony K Mbonye1*, Pascal Magnussen3, Clare IR Chandler2, Kristian S Hansen2, Sham Lal2, Bonnie Cundill2, Caroline A Lynch2 and Siân E Clarke2

Author Affiliations

1 School of Public Health, Makerere University and Ministry of Health, Box 7272, Plot 6 Lourdel Street Nakasero, Kampala, Uganda

2 London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK

3 Institute of International Health, Immunology and Microbiology, University of Copenhagen, Øster Farimagsgade 5, building 22-23, 1353, Copenhagen, K, Denmark

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Trials 2014, 15:303  doi:10.1186/1745-6215-15-303

Published: 29 July 2014

Abstract

Background

An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT). We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treatment and referral being introduced in drug shops. The intervention was designed to be evaluated through a cluster randomized trial. In this paper, we present detailed design, implementation and evaluation experiences in order to help inform future studies of a complex nature.

Methods

Three preparatory studies (formative, baseline and willingness-to-pay) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops, and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities. The intervention required careful design with the intention to be acceptable, sustainable and effective. Critical components of intervention were: community sensitization and creating awareness, training of drug shop vendors to diagnose malaria with mRDTs, treat and refer customers to formal health facilities, giving pre-referral rectal artesunate and improved record-keeping. The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT, evaluated against microscopy on a research blood slide.

Results

Introducing mRDTs in drug shops may seem simple, but our experience of intervention design, conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological, social science and health economics methodologies. The trial was conducted in phases sequenced such that each benefited from the other.

Conclusions

The main challenges in designing this trial were maintaining a balance between a robust intervention to support effective behaviour change and introducing practices that would be sustainable in a real-life situation in tropical Africa; as well as achieving a detailed evaluation without inadvertently influencing prescribing behaviour.

Trial registration

NCT01194557 registered with ClinicalTrials.gov 2 September 2010.

Keywords:
Malaria; Rapid diagnostic tests; ACT; Drug shops; Private sector; Pragmatic trial; Uganda