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Effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocol.

ABSTRACT: BACKGROUND:To combat emerging drug resistance in the Greater Mekong Sub-region (GMS) the World Health Organization and GMS countries have committed to eliminating malaria in the region by 2030. The overall approach includes providing universal access to diagnosis and treatment of malaria, and sustainable preventive measures, including vector control. Topical repellents are an intervention that can be used to target residual malaria transmission not covered by long lasting insecticide nets and indoor residual spraying. Although there is strong evidence that topical repellents protect against mosquito bites, evidence is not well established for the effectiveness of repellents distributed as part of malaria control activities in protecting against episodes of malaria. A common approach to deliver malaria services is to assign Village Health Volunteers (VHVs) to villages, particularly where limited or no services exist. The proposed trial aims to provide evidence for the effectiveness of repellent distributed through VHVs in reducing malaria. METHODS:The study is an open stepped-wedge cluster-randomised controlled trial randomised at the village level. Using this approach, repellent (N,N-diethyl-benzamide - 12% w/w, cream) is distributed by VHVs in villages sequentially throughout the malaria transmission season. Villages will be grouped into blocks, with blocks transitioned monthly from control (no repellent) to intervention states (to receive repellent) across 14 monthly intervals in random order). This follows a 4-week baseline period where all villages do not receive repellent. The primary endpoint is defined as the number of individuals positive for Plasmodium falciparum and Plasmodium vivax infections diagnosed by a rapid diagnostic test. Secondary endpoints include symptomatic malaria, Polymerase Chain Reaction (PCR)-detectable Plasmodium spp. infections, molecular markers of drug resistance and antibodies specific for Plasmodium spp. parasites. DISCUSSION:This study has been approved by relevant institutional ethics committees in Myanmar and Australia. Results will be disseminated through workshops, conferences and peer-reviewed publications. Findings will contribute to a better understanding of the optimal distribution mechanisms of repellent, context specific effectiveness and inform policy makers and implementers of malaria elimination programs in the GMS. TRIAL REGISTRATION:Australian and New Zealand Clinical Trials Registry ( ACTRN12616001434482 ). Retrospectively registered 14th October 2016.

SUBMITTER: Win Han Oo

PROVIDER: S-EPMC6295052 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe World Health Organization has yet to endorse deployment of topical repellents for malaria prevention as part of public health campaigns. We aimed to quantify the effectiveness of repellent distributed by the village health volunteer (VHV) network in the Greater Mekong Subregion (GMS) in reducing malaria in order to advance regional malaria elimination.Methods and findingsBetween April 2015 and June 2016, a 15-month stepped-wedge cluster randomised trial was conducted in 116 villages in Myanmar (stepped monthly in blocks) to test the effectiveness of 12% N,N-diethylbenzamide w/w cream distributed by VHVs, on Plasmodium spp. infection. The median age of participants was 18 years, approximately half were female, and the majority were either village residents (46%) or forest dwellers (40%). No adverse events were reported during the study. Generalised linear mixed modelling estimated the effect of repellent on infection detected by rapid diagnostic test (RDT) (primary outcome) and polymerase chain reaction (PCR) (secondary outcome). Overall Plasmodium infection detected by RDT was low (0.16%; 50/32,194), but infection detected by PCR was higher (3%; 419/13,157). There was no significant protection against RDT-detectable infection (adjusted odds ratio [AOR] = 0.25, 95% CI 0.004-15.2, p = 0.512). In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233). Repellent effects were similar when delayed effects were modelled, across risk groups, and regardless of village-level and temporal heterogeneity in malaria prevalence. The incremental cost-effectiveness ratio was US$256 per PCR-detectable infection averted. Study limitations were a lower than expected Plasmodium spp. infection rate and potential geographic dilution of the intervention.ConclusionsIn this study, we observed apparent protection against new infections associated with the large-scale distribution of repellent by VHVs. Incorporation of repellent into national strategies, particularly in areas where bed nets are less effective, may contribute to the interruption of malaria transmission. Further studies are warranted across different transmission settings and populations, from the GMS and beyond, to inform WHO public health policy on the deployment of topical repellents for malaria prevention.Trial registrationAustralian and New Zealand Clinical Trials Registry (ACTRN12616001434482).

Project description:IntroductionIn the Greater Mekong Subregion, community health workers, known as malaria volunteers, have played a key role in reducing malaria in the control phase, providing essential malaria services in areas with limited formal healthcare. However, the motivation and social role of malaria volunteers, and testing rates, have declined with decreasing malaria burden and reorientation of malaria programmes from control to elimination. Provision of additional interventions for common health concerns could help sustain the effectiveness of volunteers and maintain malaria testing rates required for malaria elimination accreditation by the WHO.Methods and analysisThe Community-delivered Integrated Malaria Elimination (CIME) volunteer model, integrating interventions for malaria, dengue, tuberculosis, childhood diarrhoea and malaria Rapid Diagnostic Test (RDT)-negative fever, was developed based on global evidence and extensive stakeholder consultations. An open stepped-wedge cluster-randomised controlled trial, randomised at the volunteer level, will be conducted over 6 months to evaluate the effectiveness of the CIME model in Myanmar. One hundred and forty Integrated Community Malaria Volunteers (ICMVs, current model of care) providing malaria services in 140 villages will be retrained as CIME volunteers (intervention). These 140 ICMVs/villages will be grouped into 10 blocks of 14 villages, with blocks transitioned from control (ICMV) to intervention states (CIME), fortnightly, in random order, following a 1-week training and transition period. The primary outcome of the trial is blood examination rate determined by the number of malaria RDTs performed weekly. Difference in rates will be estimated across village intervention and control states using a generalised linear mixed modelling analytical approach with maximum likelihood estimation.Ethics and disseminationThe study was approved by Institutional Review Board, Myanmar Department of Medical Research (Ethics/DMR/2020/111) and Alfred Hospital Ethics Review Committee, Australia (241/20). Findings will be disseminated in peer-review journals, conferences and regional, national and local stakeholder meetings.Trial registration numberNCT04695886.

Project description:BackgroundMalaria volunteers have contributed significantly to malaria control achieving a reduction of annual parasite incidence to pre-elimination levels in several townships across Myanmar. However, the volunteers' role is changing as Myanmar transitions from a malaria control to elimination programme and towards the goal of universal health coverage. The aim of the study is to explore the perspectives of community leaders, members and malaria volunteers in South-East Myanmar on community-delivered models to inform an optimal design that targets malaria elimination in the context of primary health care in Myanmar.MethodsQualitative methods including focus group discussions (FGDs) with community members and current or ex-malaria volunteers, and participatory workshops with community leaders were conducted. All data collection tools were pilot tested with similar participants. The FGDs were stratified into male and female participants in consideration of diverse gender roles among the ethnic groups of Myanmar. Data saturation was the key cut-off point to cease recruitment of participants. Inductive thematic analysis was used.ResultsCommunity members were willing to be tested for malaria because they were concerned about the consequences of malaria although they were aware that malaria prevalence is low in their villages. Malaria volunteers were the main service providers for malaria and other infectious diseases in the community. Apart from malaria, the community identified common health problems such as the flu (fever, sneezing and coughing), diarrhoea, skin infections and tuberculosis as priority diseases in this order. Incorporating preventive, and whenever possible curative, services for those diseases into the current malaria volunteer model was recommended.Discussion and conclusionThere was a gap between the communities' expectations of health services and the health services currently being delivered by volunteers in the community that highlights the need for reassessment and reform of the volunteer model in the changing context. An evidence-based, community preferred, pragmatic community-delivered integrated model should be constructed based on the context of malaria elimination and progressing towards universal health coverage in Myanmar.

Project description:ObjectiveTo evaluate the impact of Teach-Back on communication quality in a national telephone-based telehealth service, for callers varying in health literacy.DesignCross-sectional stepped wedge cluster randomised trial with continuous recruitment, short (fixed) exposure and blinded outcome assessors. Nurses were stratified by hours worked and randomised into training groups using a computer generated sequence.SettingAn Australian national pregnancy and parenting telephone helpline.InterventionComplex intervention involving a single 2-hour group Teach-Back training session, combined with ongoing nurse self-reflection on their communication following each call and each shift.ParticipantsParticipants were 637 callers to the telephone helpline aged 18-75 (87% female), of whom 127 (13%) had inadequate health literacy (measured with the Single Item Literacy Screener); and 15 maternal and child health nurses with 15 years' experience on average.MeasuresPrimary outcome was a modified subscale of the Health Literacy Questionnaire, 'having sufficient information to manage health'. Secondary caller outcomes included caller confidence, perceived actionability of information and nurse effort to listen and understand. Nurse outcomes were perceptions of their communication effectiveness.ResultsOver a 7 week period, 376 surveyed callers received usual care and 261 Teach-Back. Ratings on the primary outcome increased over time (OR 1.17, CI 1.01 to 1.32, p = 0.03) but no independent Teach-Back effect was observed. A consistent pattern suggests that, compared with usual care, Teach-Back helps callers with inadequate health literacy feel listened to (OR 2.3, CI 0.98 to 5.42, p = 0.06), confident to act (OR 2.44, CI 1.00 to 5.98, p = 0.06), and know what steps to take (OR 2.68, CI 1.00 to 7.17, p = 0.06). Nurse perceptions of both their own communication effectiveness (OR = 2.31; CI 1.38 to 3.86, p<0.0001), and caller understanding (OR = 2.56; CI 1.52 to 4.30, p<0.001) both increased with Teach-Back. No harms were reported.ConclusionsTeach-Back appears to benefit telephone health service users with inadequate health literacy, but the extent of this is unclear due to smaller numbers of lower literacy participants. Improving caller ratings over time are likely due to increasing nurse communication competence.

Project description:BACKGROUND:A mixed methods study was conducted to look at the magnitude of residual malaria transmission (RMT) and factors contributing to low (<?1% prevalence), but sustained transmission in rural communities on the Thai-Myanmar border. METHODS:A cross-sectional behaviour and net survey, observational surveys and entomological collections in both villages and forested farm huts frequented by community members for subsistence farming practices were conducted. RESULTS:Community members frequently stayed overnight at subsistence farm huts or in the forest. Entomological collections showed higher biting rates of primary vectors in forested farm hut sites and in a more forested village setting compared to a village with clustered housing and better infrastructure. Despite high levels of outdoor biting, biting exposure occurred predominantly indoors, particularly for non-users of long-lasting insecticidal nets (LLINs). Risk of biting exposure was exacerbated by sub-optimal coverage of LLINs, particularly in subsistence farm huts and in the forest. Furthermore, early waking hours when people had left the safety of their nets coincided with peaks in biting in later morning hours. CONCLUSIONS:Entomological and epidemiological findings suggest drivers and modulators of sustained infection prevalence in the area to be: higher mosquito abundance in forested areas where LLINs were used less frequently or could not be used; late sleeping and waking times coinciding with peak biting hours; feeding preferences of Anopheles taking them away from contact with LLIN and indoor residual spraying (IRS), e.g. exophagy and zoophagy; non-use of LLIN and use of damaged/torn LLIN; high population movement across the border and into forested areas thereby increasing risk of exposure, decreasing use of protection and limiting access to healthcare; and, Plasmodium vivax predominance resulting in relapse(s) of previous infection. The findings highlight gaps in current intervention coverage beyond the village setting.

Project description:BackgroundStepped wedge randomised trial designs involve sequential roll-out of an intervention to participants (individuals or clusters) over a number of time periods. By the end of the study, all participants will have received the intervention, although the order in which participants receive the intervention is determined at random. The design is particularly relevant where it is predicted that the intervention will do more good than harm (making a parallel design, in which certain participants do not receive the intervention unethical) and/or where, for logistical, practical or financial reasons, it is impossible to deliver the intervention simultaneously to all participants. Stepped wedge designs offer a number of opportunities for data analysis, particularly for modelling the effect of time on the effectiveness of an intervention. This paper presents a review of 12 studies (or protocols) that use (or plan to use) a stepped wedge design. One aim of the review is to highlight the potential for the stepped wedge design, given its infrequent use to date.MethodsComprehensive literature review of studies or protocols using a stepped wedge design. Data were extracted from the studies in three categories for subsequent consideration: study information (epidemiology, intervention, number of participants), reasons for using a stepped wedge design and methods of data analysis.ResultsThe 12 studies included in this review describe evaluations of a wide range of interventions, across different diseases in different settings. However the stepped wedge design appears to have found a niche for evaluating interventions in developing countries, specifically those concerned with HIV. There were few consistent motivations for employing a stepped wedge design or methods of data analysis across studies. The methodological descriptions of stepped wedge studies, including methods of randomisation, sample size calculations and methods of analysis, are not always complete.ConclusionWhile the stepped wedge design offers a number of opportunities for use in future evaluations, a more consistent approach to reporting and data analysis is required.

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Effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocol.

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