Introducing malaria rapid diagnostic tests at registered drug shops in Uganda: Limitations of diagnostic testing in the reality of diagnosis

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Abstract

In Uganda, around two thirds of medicines are procured from the private sector, mostly from drug shops. The introduction of malaria rapid diagnostic tests (RDTs) at drug shops therefore has the potential to make a significant contribution to targeting antimalarial drugs to those with malaria parasites. We undertook formative research in a district in Uganda in preparation for a randomised trial of RDTs in drug shops. In May to July 2009, we interviewed 9 drug shop workers, 5 health workers and 4 district health officials and carried out 10 focus group discussions with a total of 75 community members to investigate the role of drug shops and the potential for implementation of RDTs at these health care outlets.

Drug shops were seen to provide an important service to community members, the nature of which is determined by responsiveness to client demands. However, drug shops hold a liminal status: in the eyes of different actors, these outlets are at once a shop and clinic; legitimate and illegitimate; and trusted and distrusted. Malaria treatment was found to be synonymous with diagnosis. Diagnostic testing was deemed useful in theory, and community members were curious about the results, with the expectation that a test would decrease uncertainty and help secure an end to illness. However, whether testing would be sought as a routine step in treatment decisions in practice is uncertain, since the appeal of the tests waned in light of their costs and potential for results to conflict with presumed diagnosis.

Interventions that increase awareness of multiple causes and management of malaria-like illness will be needed to support the new rationalisation for malaria treatment represented by parasitological diagnosis.

Highlights

► This study analyses the potential for malaria rapid diagnostic tests (RDTs) to be introduced into registered drug shops.► The social context of drugs shops can be defined by their liminal status, a position that conflicts with adherence to clinical guidelines.► Malaria is defined by individually known symptoms and treatments rather than by the presence of parasites in the blood.► Clients’ curiosity about RDTs, to confirm known diagnoses, waned in the face of costs and conflict between results and symptoms.► Interventions should see drug shops as partners and raise awareness of multiple causes and management of malaria-like illness.

Introduction

The treatment of febrile illnesses in malaria-endemic countries has received increasing attention in the past decade, with huge efforts to scale up the use of Artemesinin Combination Therapies (ACTs) for malaria cases. The high cost of these treatments, together with recognition of the importance of non-malarial fevers, has prompted reconsideration of existing strategies of blanket antimalarial use for fever cases in favour of restricted antimalarial prescription based on evidence of malaria parasitaemia (D’Acremont et al., 2009). The World Health Organisation policy guidelines have recently changed to recommend parasitologically confirmed antimalarial treatment where possible (World Health Organisation, 2010).

Accurate microscopy testing for malaria is only available in limited locations due to its dependence upon skilled laboratory staff and technical equipment. The accuracy of results is compromised if either staff skills or equipment are lacking (Ibrahim, 1996, Ngasala et al., 2008). For parasitological diagnosis to be taken up in low-resource settings, tests that can be carried out without extensive skills or equipment are needed. The new generation of malaria rapid diagnostic tests (RDTs) fulfils these criteria, offering accurate diagnosis (Bell et al., 2001) in a relatively simple format that requires no electricity or specialized laboratory training (D’Acremont et al., 2009). RDTs are therefore seen as an important vehicle for achieving targeted malaria treatment.

To make the greatest impact on current use of antimalarials, testing needs to be available where patients currently seek treatment. RDTs are now being introduced at many government health facilities in malaria-endemic countries. However, policy makers recognise the limited reach of such activities, given that much treatment is sought outside of public health services. Several pilots and a country programme in Cambodia have also introduced the tests through community health workers (CHWs) (Bell et al., 2001, Harvey et al., 2008, Yeung et al., 2008). A major source of antimalarial treatment in many settings is private drug shops, and this has led to calls to consider including these drug shops in the scale up of RDTs (Moon, Pérez Casas, Kindermans, de Smet, & von Schoen-Angerer, 2009). There is limited evidence of the best way to scale-up RDTs in any sector, with evidence that public providers may continue to overprescribe antimalarials in spite of negative RDT results (Bisoffi et al., 2009, Hamer et al., 2007, Kyabayinze et al., 2010, Reyburn et al., 2007, Skarbinski et al., 2009). The context into which RDTs are introduced has been an important determinant of adherence to test results, with public sector workers holding a long established mindset of presumptive treatment that has been hard to leave behind (Chandler et al., 2008, Chandler et al., 2010). Pilots of more supportive packages for provider behaviour change, particularly supportive supervision, have been more effective in restricting antimalarials to parasite positive patients (D’Acremont, 2009, Hopkins, 2008, Msellem et al., 2009, Williams et al., 2008). There is less evidence of the effectiveness of RDTs in community level programmes, but findings so far suggest community volunteers are able to do tests when given suitable instructions (Harvey et al., 2008) and have adhered well to guidelines for testing and treatment (Counihan, 2009). In the Philippines, CHWs reported positive impacts of the tests on job satisfaction and standing in the community (Bell et al., 2001). In the scale up of RDTs in the periphery, implementers have stressed the need for extended initial training and continued supervision and training at the peripheral level. There is far less evidence about how RDTs are used when they are implemented in the private sector, with no published data on frequency of use or adherence to results.

Uganda has a policy of free health care and medicines at public health facilities and rapid diagnostic tests are in the process of being introduced at health centres across the country. However the public health care system has been plagued by stockouts in recent times. Perhaps related to this, an estimated 63 percent of medicines are procured from the private sector, mostly from drug shops (Rutebemberwa, Pariyo, Peterson, Tomson, & Kallander, 2009). The introduction of RDTs at drug shops therefore has the potential to make a significant contribution to targeting antimalarial drugs to those with malaria parasites. However, this contribution will be contingent upon how the tests are used, as well as the extent to which test results will affect treatment decisions. An understanding of the context into which the tests will be introduced is essential for framing analysis of the uptake and impacts of their introduction.

In this paper, we describe the context into which RDTs will be introduced in a peri-urban district in Uganda. We look at the position of drug shops for community members and the public health system and analyse the role of diagnostic tests in treatment decisions.

Section snippets

Setting and study sample

The results presented in this paper were collected as a formative research component prior to a randomized trial of the introduction of RDTs in registered private drug shops in the Mukono District of Uganda, a peri-urban area east of Kampala with a population of 850,900. This formative qualitative study was conducted in May to July 2009 with the aim to understand how people perceive the role of registered drug shops, and attitudes toward malaria treatment and diagnosis in drug shops in order to

Results

We start by describing the roles of drug shops for clients and for the public health system. We describe the liminal status of drug shops in this study: at once a shop and a clinic; legitimate and illegitimate; and trusted and distrusted. This forms the context for the second part of our results, which focuses on the role of diagnostic tests within the current use of antimalarials and laboratory tests. We describe how treatment of symptoms in practice is in effect a ‘diagnosis’, but how

At once a shop and a clinic

The registered drug shops in this study consisted of 1–2 rooms, with 1–2 staff serving at any one time. Most were located in or around trading centres and had the appearance of pharmacies, denoted with a blue cross, with medicines clearly on display behind the counter. Most were not connected to electricity or water and did not have refrigerators. Some displayed educational materials, and some drug shop workers wore white coats whilst others were smartly dressed.

Drug shops in our study were an

Malaria and its treatment, in practice

Participants in our study described malaria as an individual disease that is identifiable from your symptoms at previous episodes, for example,

‘Ok, for me when I suspect malaria, the signs I get are: headache, it’s too severe; and sour mouth. When I get that taste, and headache, I just know it’s malaria’. (R3, FGD#01 – women).

Symptoms most commonly reported by community members as indicative of them suffering with malaria, in order of frequency, were: joint pains, high fever, headache, stomach

Discussion

The idea of having malaria RDTs in drug shops was embraced by our study participants. However, our analysis of the context of care in this setting and the perception of the function of diagnostic tests suggests that RDTs could have limited impact on treatment decisions in the absence of efforts to support this new rationalisation for malaria treatment. At drug shops, malaria treatment was found to be synonymous with diagnosis. Diagnostic testing was deemed useful in theory, to satisfy curiosity

Conclusion

Drug shops are currently the first step in seeking treatment for malaria for many in Uganda. The introduction of RDTs into drug shops has the potential to drastically increase access to diagnostic testing. However, their introduction will be into an existing system of care where tests are not a core component of treatment decisions. This will require a thoughtful approach to the design of supporting interventions and careful monitoring and evaluation to assess processes and impacts of the tests

Acknowledgements

We would like to thank the District Director of Health services Mukono District, Mr. Steven Kalake, Ms Charity Wamala, Ms Deborah Namisango, Joseph Mugisha and Dennise Kasenene, for data collection. We are grateful for the time and insights given by each of the study participants.

This study was funded by a grant from ACT Consortium at London School of Hygiene and Tropical Medicine funded by the Bill and Melinda Gates Foundation.

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