Deressa W, Loha E, Balkew M, Desalegne A, Gari T, Gebremichael T, Kenea O, Jima D, Robberstad B, Overgaard H, Lindtjorn B: Combining long-lasting insecticidal nets and indoor residual spraying for malaria prevention in Ethiopia: study protocol for a cluster randomized controlled trial. Malaria Journal 2014, 13:P25.
Long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) are the two main malaria prevention strategies in Ethiopia. Although both interventions have been shown to be effective in reducing malaria transmission when applied independently, there is conflicting evidence that the two in combination is better than either one alone. The main objectives of this trial are to determine the added protection value against malaria and to evaluate the cost-effectiveness when applying IRS and LLINs together, or LLINs or IRS independently.
This trial will be conducted in Adami Tullu district of Oromia Regional State in Ethiopia from 2014 to 2016. The project will use a cluster randomized controlled trial, with four “arms”: IRS+LLINs, LLINs alone, IRS alone and control (routine practice). The sample size includes 40 clusters in each arm, each cluster with 35-45 households. Each household and each inhabitant in the household will be given a unique identification number. Households will be mapped using global positioning system. At the start of the trial, all households in the IRS+LLINs and LLINs alone “arms” of the study will be provided new LLINs free of charge. IRS with an insecticide (propoxur) will be applied in IRS+LLINs and IRS alone arms twice a year throughout the study.
Each household will be visited weekly, and blood samples will be collected from each household member with fever or history of fever. Thick and thin blood smears will be taken by finger prick and rapid diagnostic tests will be used to detect malaria at field level. Data on all self-reporting malaria patients attending health posts will be collected. The cost-effectiveness and entomological studies will be simultaneously conducted. Analysis will be based on intention to treat principle. Ethical clearance was obtained from the Ministry of Science and Technology in Ethiopia and the University of Bergen.
This trial aims to provide evidence on the combined use of IRS and LLINs for malaria prevention. We aim to answer the following research questions: Can the combined use of LLINs and IRS significantly reduce malaria incidence compared with the use of LLIN or IRS alone? And is the reduced incidence justifiably compared to the added costs? Will the combined use of LLINs and IRS reduce vector density, infection, longevity and the entomological inoculation rate? Such data is crucial in order to maximize the impact of the intervention on malaria morbidity and mortality.
MalTrials-poster-Challenges in Malaria Research
The malaria research group in Bergen was established in 2007. The two main areas of research are malaria control, and to improve our understanding of possible links between climate change and malaria.
In January 2013 we finalised all agreements regarding the Norwegian Research Council grant regarding the MalTrials project: Combining indoor residual spraying and long-lasting insecticidal nets for preventing malaria: Cluster randomised trial in Ethiopia.
This note presents an update on the progress of the planned work:
- Ethical clearance: We have applied for ethical permission to start the project, and we hope to get these permissions in July.
- Once we get permission from Ethiopian authorities, we plan to start some pilot studies on:
- Map the areas, and identify potential hot spots for malaria transmission
- Select three kebeles (about 30 Gares, villages). We shall measure the incidence; find out the variation in incidence between the villages. This will enable us to calculate the correct sample size for our trial.
- Start some entomological studies.
- We have recruited three PhD students:
- Taye Gari (epidemiology)
- Alemayehu Desalegn (Health economics)
- Oljira Kenea (Entomology)
- We plan to start the main malaria trial in early 2014.
We recently received the good news the Research Council of Norway will fund the project: “Combining indoor residual spraying and long-lasting insecticidal nets for preventing malaria: Cluster randomised trial in Ethiopia”.
This research aims to improve malaria control by evaluating the combined effect of indoor residual spraying (IRS) and long-lasting insecticidal nets (LLINs) on malaria incidence in Ethiopia. This project addresses how to promote uptake of research findings into public health programmes by enhancing our knowledge on interventions that will improve the effectiveness and coverage of malaria control programmes. It includes community randomised controlled trials to assess effectiveness of multiple interventions in combination versus one method alone within routine malaria control settings.
The clinical study objectives are to examine if IRS with insecticide and LLINs provide added protection against clinical malaria compared with LLINs alone. In the health economic part we shall estimate the costs of LLINs alone or combined with IRS, compared with current standard practice in the study settings. The study will also include studies on the anopheles mosquito where we aim to assess whether IRS with insecticide plus LLINs reduces vector biting and resting preference and density, longevity, infection and entomological inoculation rates inside houses when compared with LLIN alone.
We plan to start preliminary studies in late 2012, with start of the trial during the main malaria season in 2013. The planned study site is in the Adami Tullu area in the central part of the Rift valley in Ethiopia. This research will build up on the already established research collaboration between the University of Bergen, Addis Ababa University (School of Public Health and Aklilu Lemma Institute of Pathobiology), Hawassa University, and the Ethiopian Ministry of Health (Malaria Control).