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      Feasibility, acceptability and impact of integrating malaria rapid diagnostic tests and pre-referral rectal artesunate into the integrated community case management programme. A pilot study in Mchinji district, Malawi

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          Abstract

          Background

          The World Health Organization recommends that persons of all ages suspected of malaria should receive a parasitological confirmation of malaria by use of malaria rapid diagnostic test (RDT) at community level, and that rectal artesunate should be used as a pre-referral treatment for severe malaria to rapidly reduce parasitaemia. This paper reports on findings from a pilot study that assessed the feasibility, acceptability and effects of integrating RDTs and pre-referral rectal artesunate into the integrated Community Case Management programme in Malawi.

          Methods

          This study used mixed methods to collect information for this survey. Pre- and post-intervention, cross-sectional, household surveys were carried out. A review of integrated community case management reports, including supervision checklists was conducted. Quantitative data were collected in tablets running on open data kit software, and then data were transferred to STATA version 12 for analysis. For key indicators, proportions were calculated at 95 % confidence intervals. Qualitative data were recorded onto digital recorders, translated into English and transcribed for analysis.

          Results

          Out of 86 observed RDT performances, a total of 83 (97 %) were performed correctly with a proper disposal of sharps and biohazard wastes. Only two (2 %) febrile children who had an RDT negative result were treated with artemether–lumefantrine, contrary to malaria treatment guidelines. Utilization of community health workers (CHWs) as a first source of care increased from (33.9 %) (95 % CI; 25.5–42.3) at baseline to (89.7 %) (95 % CI; 83.5–95.5) at end line in the intervention villages. There was a corresponding decrease in the proportion of caregivers that first sought care from informal sources from 12.9 % (95 % CI; 6.9–18.9) to 1.9 % (95 % CI; 0.9–4.4) in the intervention villages. Acceptability of the use of RDTs and pre-referral rectal artesunate at the community level was relatively high.

          Conclusion

          Integration of RDTs and pre-referral rectal at artesunate community level is both feasible and acceptable. The strategy has the potential to increase and improve utilization of child health services at community level. However, this depends on the CHWs’ skills and their availability in remote areas.

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          Most cited references17

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          Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial.

          To compare rapid diagnostic tests (RDTs) for malaria with routine microscopy in guiding treatment decisions for febrile patients. Randomised trial. Outpatient departments in northeast Tanzania at varying levels of malaria transmission. 2416 patients for whom a malaria test was requested. Staff received training on rapid diagnostic tests; patients sent for malaria tests were randomised to rapid diagnostic test or routine microscopy Proportion of patients with a negative test prescribed an antimalarial drug. Of 7589 outpatient consultations, 2425 (32%) had a malaria test requested. Of 1204 patients randomised to microscopy, 1030 (86%) tested negative for malaria; 523 (51%) of these were treated with an antimalarial drug. Of 1193 patients randomised to rapid diagnostic test, 1005 (84%) tested negative; 540 (54%) of these were treated for malaria (odds ratio 1.13, 95% confidence interval 0.95 to 1.34; P=0.18). Children aged under 5 with negative rapid diagnostic tests were more likely to be prescribed an antimalarial drug than were those with negative slides (P=0.003). Patients with a negative test by any method were more likely to be prescribed an antibiotic (odds ratio 6.42, 4.72 to 8.75; P<0.001). More than 90% of prescriptions for antimalarial drugs in low-moderate transmission settings were for patients for whom a test requested by a clinician was negative for malaria. Although many cases of malaria are missed outside the formal sector, within it malaria is massively over-diagnosed. This threatens the sustainability of deployment of artemisinin combination treatment, and treatable bacterial diseases are likely to be missed. Use of rapid diagnostic tests, with basic training for clinical staff, did not in itself lead to any reduction in over-treatment for malaria. Interventions to improve clinicians' management of febrile illness are essential but will not be easy. Clinical trials NCT00146796 [ClinicalTrials.gov].
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            Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial

            Summary Background Most malaria deaths occur in rural areas. Rapid progression from illness to death can be interrupted by prompt, effective medication. Antimalarial treatment cannot rescue terminally ill patients but could be effective if given earlier. If patients who cannot be treated orally are several hours from facilities for injections, rectal artesunate can be given before referral and acts rapidly on parasites. We investigated whether this intervention reduced mortality and permanent disability. Methods In Bangladesh, Ghana, and Tanzania, patients with suspected severe malaria who could not be treated orally were allocated randomly to a single artesunate (n=8954) or placebo (n=8872) suppository by taking the next numbered box, then referred to clinics at which injections could be given. Those with antimalarial injections or negative blood smears before randomisation were excluded, leaving 12 068 patients (6072 artesunate, 5996 placebo) for analysis. Primary endpoints were mortality, assessed 7–30 days later, and permanent disability, reassessed periodically. All investigators were masked to group assignment. Analysis was by intention to treat. This study is registered in all three countries, numbers ISRCTN83979018, 46343627, and 76987662. Results Mortality was 154 of 6072 artesunate versus 177 of 5996 placebo (2·5% vs 3·0%, p=0·1). Two versus 13 (0·03% vs 0·22%, p=0·0020) were permanently disabled; total dead or disabled: 156 versus 190 (2·6% vs 3·2%, p=0·0484). There was no reduction in early mortality (56 vs 51 deaths within 6 h; median 2 h). In patients reaching clinic within 6 h (median 3 h), pre-referral artesunate had no significant effect on death after 6 h or permanent disability (71/4450 [1·6%] vs 82/4426 [1·9%], risk ratio 0·86 [95% CI 0·63–1·18], p=0·35). In patients still not in clinic after more than 6 h, however, half were still not there after more than 15 h, and pre-referral rectal artesunate significantly reduced death or permanent disability (29/1566 [1·9%] vs 57/1519 [3·8%], risk ratio 0·49 [95% CI 0·32–0·77], p=0·0013). Interpretation If patients with severe malaria cannot be treated orally and access to injections will take several hours, a single inexpensive artesunate suppository at the time of referral substantially reduces the risk of death or permanent disability. Funding UNICEF/UNDP/World Bank Special Programme for Research and Training in Tropical Diseases (WHO/TDR); WHO Global Malaria Programme (WHO/GMP); Sall Family Foundation; the European Union (QLRT-2000-01430); the UK Medical Research Council; USAID; Irish Aid; the Karolinska Institute; and the University of Oxford Clinical Trial Service Unit (CTSU).
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              Community Health Workers Use Malaria Rapid Diagnostic Tests (RDTs) Safely and Accurately: Results of a Longitudinal Study in Zambia

              Malaria rapid diagnostic tests (RDTs) could radically improve febrile illness management in remote and low-resource populations. However, reliance upon community health workers (CHWs) remains controversial because of concerns about blood safety and appropriate use of artemisinin combination therapy. This study assessed CHW ability to use RDTs safely and accurately up to 12 months post-training. We trained 65 Zambian CHWs, and then provided RDTs, job-aids, and other necessary supplies for village use. Observers assessed CHW performance at 3, 6, and 12 months post-training. Critical steps performed correctly increased from 87.5% at 3 months to 100% subsequently. However, a few CHWs incorrectly read faint positive or invalid results as negative. Although most indicators improved or remained stable over time, interpretation of faint positives fell to 76.7% correct at 12 months. We conclude that appropriately trained and supervised CHWs can use RDTs safely and accurately in community practice for up to 12 months post-training.
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                Author and article information

                Contributors
                tphiri@mac.medcol.mw
                bkaunda@mac.medcol.mw
                abauleni@mac.medcol.mw
                tiyese.chimuna@savethechildren.org
                david.melody@savethechildren.org
                humphreys.kalengamaliro@savethechildren.org
                johnsande33@gmail.com
                hnsona@gmail.com
                dmathang@mac.medcol.mw
                Journal
                Malar J
                Malar. J
                Malaria Journal
                BioMed Central (London )
                1475-2875
                21 March 2016
                21 March 2016
                2016
                : 15
                : 177
                Affiliations
                [ ]Malaria Alert Centre, College of Medicine, Blantyre, Malawi
                [ ]Save the Children Malawi, Lilongwe, Malawi
                [ ]Ministry of Health, Lilongwe, Malawi
                Article
                1237
                10.1186/s12936-016-1237-2
                4802711
                27000034
                2d555fad-b9f9-42c5-90a8-3e3180b65d61
                © Phiri et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 5 January 2016
                : 16 March 2016
                Funding
                Funded by: Save the Children Malawi
                Categories
                Research
                Custom metadata
                © The Author(s) 2016

                Infectious disease & Microbiology
                pre-referral rectal artesunate,hard to reach areas,malaria rapid diagnostic tests,feasibility,correct performance of rdts

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