Abstract
BackgroundAn 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.MethodsThree 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.ResultsIntroducing 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.ConclusionsThe 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 registrationNCT01194557 registered with ClinicalTrials.gov 2 September 2010.
Highlights
An intervention was designed to introduce rapid diagnostics tests for malaria into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT)
Strategies to ensure prompt effective treatment with artemisinin-based combination therapy (ACT) in Africa need to take into account the role of drug shops in management of malaria and to ensure that appropriate anti-malarial drugs are sold to patients [6]
Balancing robust interventions with real-life situations Another challenge was maintaining a balance between a robust intervention and introducing practices that would be sustainable in a real-life situation for example, introducing records for Drug shop vendor (DSV) aimed at evaluating the intervention
Summary
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. Strategies to ensure prompt effective treatment with artemisinin-based combination therapy (ACT) in Africa need to take into account the role of drug shops in management of malaria and to ensure that appropriate anti-malarial drugs are sold to patients [6]. The World Health Organization (WHO) recommends that management of malaria should include confirmation, either microscopically or with an antigen-based rapid diagnostic test (mRDTs), of all suspected malaria cases before treatment with relatively costly ACT [6]. The availability of diagnostic confirmation in drug shops may increase willingness to pay for new ACT treatment since customers would clearly know whether they have malaria or not
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