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

Mbonye AK, Magnussen P, Chandler CI, Hansen KS, Lal S, Cundill B, Lynch CA, Clarke SE - Trials (2014)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: School of Public Health, Makerere University and Ministry of Health, Box 7272, Plot 6 Lourdel Street Nakasero, Kampala, Uganda. vpadmn@infocom.co.ug.

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.

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Related in: MedlinePlus

Logical model to explain elements of the intervention.
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Fig1: Logical model to explain elements of the intervention.

Mentions: The content of the intervention was based on findings from the formative research of public health officials, non-governmental organization (NGO) staff and researchers and policymakers with previous experiences of implementing interventions with DSVs in Uganda. This helped to develop the underlying principles for the intervention (Table 1, Figure 1) and to situate the intervention in the context of other public health programs. The intervention was designed to address key deficiencies and challenges to appropriate diagnosis and treatment in drug shops, such as the lack of training in national malaria treatment guidelines, lack of reference materials (guidelines, job aids), limited record-keeping in shops and weak linkages with the public health system, which had been identified during the formative research. The intervention arm received training to cover the rationale for diagnostic testing in febrile patients, performing an mRDT and interpretation of the test result, while drug shop vendors (DSVs) in the control arm were trained in presumptive diagnosis of malaria.Table 1


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

Mbonye AK, Magnussen P, Chandler CI, Hansen KS, Lal S, Cundill B, Lynch CA, Clarke SE - Trials (2014)

Logical model to explain elements of the intervention.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4125706&req=5

Fig1: Logical model to explain elements of the intervention.
Mentions: The content of the intervention was based on findings from the formative research of public health officials, non-governmental organization (NGO) staff and researchers and policymakers with previous experiences of implementing interventions with DSVs in Uganda. This helped to develop the underlying principles for the intervention (Table 1, Figure 1) and to situate the intervention in the context of other public health programs. The intervention was designed to address key deficiencies and challenges to appropriate diagnosis and treatment in drug shops, such as the lack of training in national malaria treatment guidelines, lack of reference materials (guidelines, job aids), limited record-keeping in shops and weak linkages with the public health system, which had been identified during the formative research. The intervention arm received training to cover the rationale for diagnostic testing in febrile patients, performing an mRDT and interpretation of the test result, while drug shop vendors (DSVs) in the control arm were trained in presumptive diagnosis of malaria.Table 1

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: School of Public Health, Makerere University and Ministry of Health, Box 7272, Plot 6 Lourdel Street Nakasero, Kampala, Uganda. vpadmn@infocom.co.ug.

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.

Show MeSH
Related in: MedlinePlus