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Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol)

Augustincic Polec L, Uefng E, Welch V, Tanjong Ghogomu E, Pardo Pardo J, Grabowsky M, Attaran A, Tugwell P

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2011, Issue 6 http://www.thecochranelibrary.com

Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS HEADER . . . . . . . . . . ABSTRACT . . . . . . . . . BACKGROUND . . . . . . . OBJECTIVES . . . . . . . . METHODS . . . . . . . . . Figure 1. . . . . . . . . Figure 2. . . . . . . . . ACKNOWLEDGEMENTS . . . REFERENCES . . . . . . . . APPENDICES . . . . . . . . HISTORY . . . . . . . . . . CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST . SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2 3 3 4 5 8 9 10 12 12 12 12

Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

[Intervention Protocol]

Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria
Lana Augustincic Polec1 , Erin Uefng1 , Vivian Welch1 , Elizabeth Tanjong Ghogomu1 , Jordi Pardo Pardo1 , Mark Grabowsky2 , Amir Attaran1 , Peter Tugwell3 for Global Health, Institute of Population Health, University of Ottawa, Ottawa, Canada. 2 National Vaccine Program Ofce, Washington, D.C., USA. 3 Department of Medicine, University of Ottawa, Ottawa, Canada Contact address: Lana Augustincic Polec, Centre for Global Health, Institute of Population Health, University of Ottawa, 1 Stewart Street, Ottawa, Ontario, K1N 6N5, Canada. laugusti@uottawa.ca. Editorial group: Cochrane Effective Practice and Organisation of Care Group. Publication status and date: New, published in Issue 6, 2011. Citation: Augustincic Polec L, Uefng E, Welch V, Tanjong Ghogomu E, Pardo Pardo J, Grabowsky M, Attaran A, Tugwell P. Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria. Cochrane Database of Systematic Reviews 2011, Issue 6. Art. No.: CD009186. DOI: 10.1002/14651858.CD009186. Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
1 Centre

ABSTRACT This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the evidence on the effectiveness and equity of available strategies that focus on delivery and the proper use of ITNs. To assess the impact of different strategies on equity ratio of household ownership and proper use.

Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

BACKGROUND
not have a habit of using them, so they need to be convinced of their usefulness and persuaded to use them on a regular basis (WHO 2010a). The culture of ITN use is more developed among some ethnic groups and it has a signicant impact on ITN coverage. Wealth, living in an urban rather than rural area and higher levels of education are other important factors positively associated with ITN ownership and use, and their impacts on coverage need to be assessed (Belay 2008; Eisele 2009b; Monasch 2004).

Description of the condition


Malaria is a life-threatening parasitic disease transmitted by female Anopheles mosquitoes. Approximately 40% of the worlds population is at risk of malaria; those at risk are primarily in the worlds poorest countries. The geographic spread of malaria used to be much broader, but it was eradicated successfully in many countries with temperate climates during the mid-20th century (WHO 2010a). Malaria can cause a signicant economic burden at both the individual and the regional level; it can have an enormous and long-lasting effect on economic growth and development. Malaria also contributes to localized differences in gross domestic product (GDP) between countries with and without malaria, especially in Africa. According to the World Health Organization (WHO), in some countries personal and public spending on costs related to malaria accounts for up to 40% of public health expenditures, 30% to 50% of inpatient hospital admissions, [and] up to 60% of outpatient health clinic visits. The costs of malaria are borne disproportionately by those who can afford them the least; the poor who cannot afford treatment and those who have limited access to health services are burdened the most (WHO 2010b). According to the WHO World Malaria Report 2010, global estimates of the malaria disease burden for 2009 indicated that there were 225 million cases of malaria. The increase in international funding for malaria has resulted in better access to malaria preventive measures (WHO 2010c). Efcacious malaria prevention strategies include insecticide-treated bed nets (ITNs) (Lengeler 2004), indoor residual spraying and screens (Morel 2005). Malaria has the highest impact on young children who have not developed acquired immunity. In pregnant women, malaria is associated with increased risk of severe anaemia, low birth weight, as well as with an increase in miscarriages and maternal deaths (Desai 2007; WHO 2010b). However, the proportion of children under ve years and pregnant women sleeping under ITNs is still too low (Alaii 2003; Eisele 2009a). According to surveys conducted in Africa between 1999 and 2004, with the median survey year 2001, the median proportion of children under ve sleeping under ITNs was only 3%. In countries with subsidized or free-of-charge ITN distribution, use has been scaled up successfully (WHO 2005a). By mid-2010, ITN ownership increased in Africa; 42% of households owned at least one ITN and 35% of children slept under one (WHO 2010c). One of the barriers to the effective use of ITNs is the associated cost. Populations affected by malaria are among the poorest in the world and they may not be able to afford them. For example, one Kenyan study found that although rural residents wanted to use ITNs, they could not afford them; it was estimated that ITNs for an entire household would cost about the same as paying for three children to attend one year of primary school (Guyatt 2002). Another barrier is that people are often unfamiliar with ITNs, or do

Description of the intervention


WHO denes an insecticide-treated net as a mosquito net that repels, disables and/or kills mosquitoes coming into contact with insecticide on the netting material (WHO 2007). Large increases in funding and attention to malaria have accelerated malaria control activities in many countries, in particular those associated with ITNs. The production of ITNs has increased worldwide from 30 million in 2004 to 95 million in 2007. Increased funding contributed to the rapid rise in the number of ITNs procured and distributed within countries. For example, the United Nations Childrens Fund (UNICEF) increased its procurement from 7 million in 2004 to nearly 20 million in 2007, and the Global Fund increased its distribution from 1.35 million in 2004 to 18 million in 2006. In two of four African countries where repeated national surveys were conducted, household ownership decreased by 13% and 37% within 24 to 36 months of mass ITN distribution campaigns. After free ITN distribution in Kenya, the adherence was lower than desired and 30% of ITNs remained unused (Alaii 2003). Therefore, it is important to identify strategies that will increase the ownership of ITNs and encourage proper use. Proper use of ITNs requires that they are hanging properly and that they are used consistently (Eisele 2009b). ITNs should also be in good condition, contain an active and sufcient dose of insecticide, and not be torn or otherwise damaged. Strategies to increase the use of ITNs include social marketing, health education campaigns by multidisciplinary teams, developing a net culture through promotion and publicity, increased availability (e.g. local production of high-quality ITNs), free ITN distribution campaigns and cost reduction (e.g. reduced taxes imposed on ITNs) (WHO 2010a). Identied effective strategies should be used to scale-up ITNs and to achieve universal coverage. Strengthening healthcare systems is very important in this process, but it cannot be done quickly. In order to reach high national coverage, lessons learned from ongoing ITN programs and reviews should be applied. According to Roll Back Malaria, the initial step in scaling up should integrate short-term strategies to increase ITN coverage rapidly by offering subsidized ITNs to the most vulnerable populations (WHO 2005b). The second step should include long-term strategies that focus on sustainability and systems that sustain high ITNs coverage and appropriate use by the most vulnerable groups. A national ITN partners committee should co-ordinate efforts of public, pri2

Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

vate and non-governmental partners and facilitate ITN scale-up (WHO 2005b). The WHO Global Malaria Programme (WHO/GMP) emphasizes that the sustainability of high ITN coverage and scalingup access to and use of long-lasting insecticidal nets (LLINs) are some of the key issues in malaria prevention (WHO 2007). Incorporating ITN campaigns into existing successful campaigns (e.g. measles vaccination campaigns) may be a good approach to achieve a rapid catch-up and keep-up (Grabowsky 2007a). The focus of malaria prevention campaigns should be on proper and regular use of ITNs, continuing access to ITNs for newborns and pregnant women, and ensuring an affordable cost of ITNs for the rest of the population (Grabowsky 2007b). In many sub-Saharan African countries, rapid progress in malaria control has been observed, and higher and more widely applied ITN coverage is expected. Current challenges to equitable distribution of ITNs appear to be linked to the policies and intervention delivery strategies (Kilian 2010; Steketee 2009). The effectiveness, sustainability and equity of these strategies to increase the use of ITNs, especially ITN scale-up strategies, are unclear. Consequently, there is a lack of guidance for policy-makers on effective strategies related to the use of ITNs. This review will assess current evidence on such strategies and it will provide policymakers with guidance on how ITNs can be used effectively to help roll back malaria.

METHODS

Criteria for considering studies for this review

Types of studies We will include studies that report on strategies that may increase the ownership and the proper use of ITNs. It may be difcult and inappropriate to evaluate these interventions using randomized controlled trials (RCTs), because scale-up strategies are delivered at a population level and are the standard of care in at-risk populations (WHO 2010c). Thus, we will include non-randomized studies in our review. Studies to be included are: randomized and quasi-randomized controlled trials (RCTs, controlled clinical trials (CCTs), cluster-RCTs); controlled before and after studies (CBAs) with contemporaneous data collection and with two or more control and intervention sites; and interrupted time series studies (ITSs) with a clearly dened point in time when the intervention occurred and at least three data points before and after implementation of the intervention. We will include any other study design that meets EPOC study design criteria, regardless of the name (e.g. stepped wedge design, controlled interrupted time series). We will exclude studies focusing solely on the effectiveness of ITNs as this research question is addressed in another Cochrane systematic review (Lengeler 2004). We will exclude study designs that do not meet the EPOC criteria from meta-analyses or narrative syntheses as applicable, but may use them to inform the discussion and the background for the review.

Why it is important to do this review


This review addresses one of the emerging global health issues that is a core part of the United Nations Millennium Development Goal (MDG) #6, Combat HIV/AIDS, Malaria and other diseases (UN 2008). By identifying effective ITN delivery mechanisms, the strategies aiming at proper ITN use, and the contexts and populations in which they are effective, this review can help policymakers and practitioners to make appropriate and evidence-based decisions. The use of rigorous research methods will ensure highquality evidence for effective strategies to increase the proper use of ITNs.

Types of participants We will include children and adults with permanent residence in malarious areas in our study. We will exclude military populations, travelers, students, those who live in transient refugee camps for less than one malaria season, and others not permanently residing in the study area.

Types of interventions

OBJECTIVES
To assess the evidence on the effectiveness and equity of available strategies that focus on delivery and the proper use of ITNs. To assess the impact of different strategies on equity ratio of household ownership and proper use.

Our systematic review will include both unifaceted and multifaceted interventions that may increase the ownership and proper use of ITNs. To clarify the relationship between the interventions and the outcomes, we developed a logic model (Tugwell 2010) (Figure 1 and Figure 2). Interventions are grouped into three main categories depending on their focus: interventions focusing on ITN delivery strategies, interventions focusing on proper use of ITNs and combinations of these interventions.

Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Figure 1. LOGIC MODEL: Strategies to increase the use of insecticide-treated bed nets in households and vulnerable populations to reduce morbidity and mortality from malaria in endemic settings

Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Figure 2. Types of interventions to increase the use of ITNs

The framework for ITN delivery mechanism strategies by Kilian et al was adapted and incorporated into our logic model. Categories that are dened by this framework include ITN delivery channel, duration of distribution, cost to user, choices of a net in terms of net preference and accessibility, and sectors involved in the distribution (Kilian 2010). Interventions focusing on proper ITN use strategies after ITN distribution are mapped similarly as previously described for ITN delivery mechanisms. Examples for these interventions are: campaigns to increase ITN hang-up and volunteer home visits to educate populations about the proper use of ITNs. Interventions to encourage proper use can be delivered through different channels (community, outreach, routine services and at retail points). These interventions can be provided during limited periods of time (single or repeated) or they can be ongoing (continuous). Proper use interventions can be delivered by the public sector (e.g. government) or private sector (civil society: non-governmental organizations (NGOs), faith and community-based organizations; and commercial sector). Interventions are further categorized as those focusing on education, peer monitoring (e.g. volunteer home visits) or publicity (e.g. media). We decided not to use the categories Cost to user and Choice of type and time in our logic model.

We will report relevant context information that may impact the proper use of ITNs (e.g. national/regional culture, ITN stock-out periods, nomadic lifestyle). Comparison groups will include no intervention and other strategies aiming to increase ITN use (e.g. comparing two different interventions that are aiming to increase ITN use). Types of outcome measures

Primary outcomes

Proportion of households with at least one ITN. Proportion of existing ITNs used (the previous night and when a time frame is not reported). Proportion of population sleeping under ITNs (the previous night and when a time frame is not reported). Proportion of pregnant women sleeping under ITNs (the previous night and when a time frame is not reported). Proportion of children under ve sleeping under ITNs (the previous night and when a time frame is not reported). Proportion of households with all children under ve sleeping under ITNs (the previous night and when a time frame

Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

is not reported). Proportion of households with people/ITN ratio 2.0 among households with any nets. Equity ratio of household ownership with ITNs calculated across household income.

Secondary outcomes

Child all-cause mortality. Child malaria-specic mortality. Child malaria morbidity. All-cause mortality. Malaria-specic mortality. Malaria-specic morbidity. Anemia in pregnant women. Low birth weight.

The focus of our review is the use of ITNs measured with the coverage outcomes that are dened as ITN ownership or the use of ITNs. Coverage outcomes are sometimes reported in an inconsistent manner. In order to reduce bias when reporting study ndings, we will report coverage-related outcomes that do not fall under any of the above outlined categories as published in the original paper (e.g. if time frame of use is not specied). If identied studies report on ITNs existing prior to the intervention, we will account for them in our analysis. We will record clinical indicators and those focusing on morbidity and mortality as secondary outcomes. The outcome measures that we selected for our review overlap to a great extent with Roll Back Malaria Monitoring & Evaluation Reference Group (MERG) minimum standards recommended for assessing malaria impact in countries in SubSaharan Africa (Kilian 2011). We will also include measures of population knowledge, attitudes and satisfaction in our discussion. If any adverse or any unintended effects are reported (e.g. unable to afford other necessities due to money use by households to purchase ITNs) we will record them.

b) The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, latest issue) c) The Cochrane Effective Practice and Organization of Care Group (EPOC) Specialized Register and the database of studies awaiting assessment d) The Cochrane Infectious Diseases Groups Specialized Register e) EMBASE f ) Latin American and Caribbean Health Sciences Literature database (LILACS) g) ISI Web of Knowledge Cited Reference Search h) African Index Medicus i) The Abdul Latif Jameel Poverty Action Lab j) The Malaria in Pregnancy Library k) A selection of low and middle-income countries databases chosen from the compilation of the Norwegian satellite of the Cochrane EPOC Group as being potentially relevant for malaria and ITNs: 3ie Database of Impact Evaluations, British Library for Development Studies (BLDS), WHO Global Health Library, IEAS Economic and Finance database (RePEc), JOLIS library catalogue, PAHO Library Catalogue, WHOLIS, World Bank Documents & Reports, AFROLIB Database, IndMED, MedCarib, South African Medical Database (SAMED), African Journals OnLine (AJOL) and Bioline International.

Searching other resources We will search the reference lists of all included studies and relevant reviews. We will contact authors of relevant papers regarding any further published or unpublished work. We will search for papers that cite studies included in the review. We will contact authors of other reviews in the eld of malaria control and prevention regarding relevant studies of which they may be aware. We will contact agencies that conduct studies or provide funding for malaria interventions with a request for data from unpublished and ongoing studies. These agencies may include the World Bank, the Rockefeller Foundation, UNICEF, the World Health Organization, the Pan American Health Organization, the International Federation of Red Cross and Red Crescent Societies, USAID and the Alliance for Malaria Prevention. We will attempt to identify all relevant studies regardless of language or publication status (published, unpublished, in press and in progress). We will search the following grey literature sources: Google Scholar, Open SIGLE, British Library Catalogue, New York Academy of Medicine Grey Literature Collection, AEGIS, and ProQuest Dissertation & Theses Database. We will report the results of the search using the PRISMA ow diagram (Higgins 2011).

Search methods for identication of studies


The Cochrane EPOC Group Trials Search Co-ordinator (TSC) designed a search strategy for the OVID MEDLINE database(see Appendix 1). The TSC will translate this strategy for the databases listed below and will apply methodological lters to identify acceptable study designs (see Types of studies) as necessary. However, given that a search of OVID MEDLINE(1948 forward) identied fewer than 2000 citations before the application of lters, we may decide to screen all search results(i.e. non-ltered search results). We will delineate this process clearly in the review manuscript.

Electronic searches We will search the following databases. a) MEDLINE

Data collection and analysis


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Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Selection of studies Two review authors will independently screen all titles and abstracts for potentially relevant studies. Two independent review authors will retrieve and screen against the inclusion criteria fulltext copies of all papers that are deemed potentially eligible by consensus. Any disagreement about the eligibility will be resolved by discussion between the two review authors and by consulting a third review author as necessary. Data extraction and management Two review authors will independently undertake data extraction from the full text of each eligible study based on the EPOC Data Collection Checklist (EPOC 2010a). Any disagreement will be resolved by discussion between the review authors and consultation with a third author if required. If any data are missing, we will contact the relevant corresponding authors. We will collect data for specic populations and address these data in subgroup analysis. Assessment of risk of bias in included studies Two review authors will independently assess the methodological quality of included studies. For RCTs, we will assess the risk of bias using the Cochrane Collaborations Risk of bias tool (Higgins 2011), which assesses the following domains: generation of randomization sequence, allocation concealment, blinding (population, provider, outcome assessor), selective outcome reporting, incomplete outcome data and other sources of bias (e.g. major baseline differences, early stopping, etc.). Due to the characteristics of interventions that we will be exploring in our review, blinding of study participants and providers may not be possible, however this will still present a risk of bias. For other study designs, we will use the risk of bias criteria suggested by EPOC: generation of allocation sequence; concealment of allocation; baseline outcome measurements; baseline characteristics; incomplete outcome data; blinding of outcome assessor; protection against contamination; independence of intervention from other changes; pre-specied shape of the intervention; intervention unlikely to affect data collection; selective outcome reporting; and other risks of bias (EPOC 2010b). Any disagreements will be resolved by discussion, and with a third review author when necessary. We will assess the quality of evidence for each main outcome using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and the GradePro software (Guyatt 2008).

Measures of treatment effect We will report pre-intervention and post-intervention means or proportions for both study and control groups and calculate unadjusted and adjusted (for any baseline imbalance) absolute change from baseline with 95% condence intervals, where baseline results are available from RCTs, CCTs and CBAs. We will account for existing ITNs when reported by authors. For ITS studies, we will report the main outcomes and two effect sizes: the change in the level of outcome immediately after the introduction of the intervention and the change in the slopes of the regression lines. We will report ndings from each study design (RCTs, CCTs and CBAs) separately. We will report median effect size across included studies, inter-quartile ranges of effect sizes across included studies and range of effect sizes across included studies. Where studies report more than one measure for each endpoint, we will abstract the primary measure (as dened by the authors of the study).

Unit of analysis issues We will attempt to re-analyze studies with potential unit of analysis errors where possible. If a comparison is re-analyzed, then we will quote the P value and annotate it with re-analyzed. If this is not possible, we will report only the point estimate. In cluster-randomized trials, a cluster is the unit of allocation. The cluster refers to a group of individuals enrolled in the study such as medical practices, villages or families. The individuals within a cluster may be more similar in their characteristics, therefore it would be incorrect to analyze the data as if the individual participants are the unit of allocation. For cluster-randomized trials with unit-of-analysis errors, we will use statistical methods to perform the analysis at the individual level while accounting for intercluster correlation. We will use the Cochrane Handbook for Systematic Reviews of Interventions methods to calculate the variance ination factor (Higgins 2011). We will search for appropriate intraclass correlation coefcients (ICC) from studies or authors. We will compare these ICCs with those used by the Lengeler et al Cochrane Review on ITNs (Lengeler 2004). If a comparison is reanalyzed, we will annotate it as reanalyzed. We will use time series regression to reanalyze each comparison when accounting for unit of analysis errors in ITS designs, in consultation with a statistician.

Dealing with missing data We will attempt to obtain missing data from the authors of the included studies. When this is not possible, we will perform the analysis using only the available data. We will explore the impact of missing data on the review ndings in the Discussion section of our review.
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Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Assessment of heterogeneity We will initially describe the variability of interventions identied in our review using a logic model described in Figure 1 and Figure 2. If meta-analysis is possible, we will explore heterogeneity using forest plots and the I2 statistic. We will perform Chi2 tests and evaluate P values using 0.10 as a cut-off point. The importance of I2 will depend on the strength of evidence of heterogeneity (P value from Chi2 test or a condence interval for I2 ) and on the magnitude and direction of effects.

Assessment of reporting biases We will use funnel plots to explore the possibility of publication bias. They will be used if 10 or more studies are included in metaanalysis and if studies are of a different size. We will visually inspect funnel plots for asymmetry and explore reasons for asymmetry.

narrative only. We will categorize and describe data according to population, intervention, setting and outcome as described above. We will report the overall number of studies included in the review and the main research questions addressed. We will comment on study designs, analytical methods used, methodological quality, generalizability and relevance of study results as well as other important study characteristics. We will explore differences and similarities between included studies with the emphasis on explanation for potential differences between study results, taking into account the context where the intervention was implemented. We will accompany the descriptive narrative with a table that summarizes characteristics and ndings of included studies in a consistent and systematic manner, following our logic model (Figure 1 and Figure 2). Subgroup analysis and investigation of heterogeneity We will conduct subgroup analysis to explore heterogeneity, according to the following study characteristics: the type of intervention as per logic model (Figure 1 and Figure 2) (e.g. cost to end user), specic population characteristics (e.g. gender/sex, ethnicity, geographic areas, rural/urban, socioeconomic status, education, age/subgroup (children under ve years and pregnant women)), and the number and type of interventions in each strategy (unifaceted interventions versus multifaceted interventions). Unifaceted interventions are interventions with only one component (e.g. ITN distribution only), whereas multifaceted interventions consist of two or more components (e.g. free ITNs bundled with education about proper ITN use). Sensitivity analysis If meta-analysis is conducted, we will perform sensitivity analysis considering the relevant issues identied during the review process. For example, we will perform a sensitivity analysis to assess whether a difference in parameters used for reporting the use of ITNs impacts our ndings (e.g. ITN usage reported with the time frame the previous night and without specifying the time frame). We plan to investigate the following study characteristics: xedeffect versus random-effects; odds ratios versus risk ratios; studies with versus without imputation for standard deviations; and RCTs versus non-RCTs.

Data synthesis We will carry out meta-analysis only if we are able to identify a sufcient number of studies that are homogeneous regarding populations, interventions and comparisons. We will use a randomeffects model for meta-analyses. If meta-analyses are not possible, we will provide a narrative summary. We will perform data synthesis using Review Manager 5.1 (RevMan) (RevMan 5.1). We will present the main ndings in a Summary of ndings table using the GradePro software. We will synthesize information about study methods (e.g. study design, duration of intervention, follow up), participants (e.g. sex, age, country, setting), intervention (e.g. intervention description and its components, means of delivery, methods of communication), setting (for both control and intervention group if available), outcomes (list of outcomes and time points reported), and notes (other details of the study that do not fall under mentioned categories). We will report the outcomes of interest as published in the original paper. Due to inconsistency in reporting of outcomes, we may not be able to pool them, but for similar outcomes we will report the direction of the effect (e.g. we will view households with at least one ITN versus households with properly hanging ITN as similar outcomes). Some outcome measurements could be considered more reliable than others (e.g. inspection of the ITN in the house versus self-reporting of the use of the ITN) so we will also report the outcomes grouped by the way in which the outcome was assessed, if appropriate. We will include the magnitude of the effects of the interventions and the quality of evidence, and summarize available data on each of the main outcomes of interest. We will include both relative and absolute measures of effect when possible. If the number of studies is insufcient for meta-analysis and data are heterogeneous in respect to populations, interventions, comparisons and outcomes, we will report the review as a descriptive

ACKNOWLEDGEMENTS
We would like to thank UNICEF and the African Leaders Malaria Alliance (ALMA), the organizers of the Enhancing Mosquito Net Utilization Meeting, Geneva 2011 and the meeting participants for their support and useful comments on the draft of the protocol. We would also like to thank Don de Savigny and Kara Hanson who encouraged us when we applied for the funding and provided
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Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

letters of collaboration. We would like to express our gratitude to Michelle Fiander, Trials Search Co-ordinatory, EPOC Group, for her help with search strategy development and Elizabeth Paulsen, Susan Munabi-Babigumira, Jenny Hill and Jan Odgaard-Jensen for their support and guidance.

REFERENCES

Additional references
Alaii 2003 Alaii JA, Hawley WA, Kolczak MS, ter Kuile FO, Gimnig JE, Vulule JM, et al.Factors affecting use of permethrintreated bed nets during a randomized controlled trial in western Kenya. American Journal of Tropical Medicine and Hygiene 2003;68(Suppl 4):13741. Belay 2008 Belay M, Deressa W. Use of insecticide treated nets by pregnant women and associated factors in a pre-dominantly rural population in northern Ethiopia. Tropical Medicine and International Health 2008;13(10):130313. Desai 2007 Desai M, ter Kuile FO, Nosten F, McGready R, Asamoa K, Brabin B, et al.Epidemiology and burden of malaria in pregnancy. Lancet Infectious Diseases 2007;7(2):93104. Eisele 2009a Eisele TP, Keating J, Littrell M, Larsen D, Macintyre K. Assessment of insecticide-treated bednet use among children and pregnant women across 15 countries using standardized national surveys. American Journal of Tropical Medicine and Hygiene 2009;80(2):20914. Eisele 2009b Eisele T, Root B. Insecticide-treated net use among children and pregnant women in sub-Saharan Africa: systematic review of the evidence. Johns Hopkins University Center for Communications Programs 2009. EPOC 2010a Cochrane Effective Practice and Organisation of Care Review Group (EPOC). Data Collection Checklist. Available from: http://epoc.cochrane.org/sites/ epoc.cochrane.org/les/uploads/datacollectionchecklist.pdf (accessed July 2010). EPOC 2010b Cochrane Effective Practice and Organisation of Care Review Group (EPOC). EPOC resources for review authors. Available from: http://epoc.cochrane.org/epocresources-review-authors (accessed July 2010). Grabowsky 2007a Grabowsky M, Nobiya T, Selanikio J. Sustained high coverage of insecticide-treated bednets through combined Catch-up and Keep-up strategies. Tropical Medicine & International Health 2007;12(7):81522.

Grabowsky 2007b Lengeler C, Grabowsky M, Mcguire D, de Savigny D. Quick wins versus sustainability: options for the upscaling of insecticide-treated nets. American Journal of Tropical Medicine and Hygiene 2007;77 (Suppl 6):2226. Guyatt 2002 Guyatt HL, Ochola SA, Snow RW. Too poor to pay: charging for insecticide-treated bednets in highland Kenya. Tropical Medicine and International Health 2002;7(10): 84650. Guyatt 2008 Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al.GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336(7650): 9246. Higgins 2011 Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochranehandbook.org. Kilian 2010 Kilian A, Wijayanandana N, Ssekitoleeko J. Review of delivery strategies for insecticide treated mosquito nets are we ready for the next phase of malaria control efforts?. TropIKA.net 2010;1(1):128. [: ISSN 20788606] Kilian 2011 Kilian A. Measuring Universal Coverage with LLIN. AMP 2011 Partners Meeting: The Alliance for Malaria Prevention. Expanding the ownership and use of mosquito nets 2011. Lengeler 2004 Lengeler C. Insecticide-treated bed nets and curtains for preventing malaria. Cochrane Database of Systematic Reviews 2004, Issue 3. [DOI: 10.1002/ 14651858.CD000363.pub2] Monasch 2004 Monasch R, Reinisch A, Steketee RW, Korenromp EL, Alnwick D, Bergevin Y. Child coverage with mosquito nets and malaria treatment from population-based surveys in african countries: a baseline for monitoring progress in roll back malaria. American Journal of Tropical Medicine and Hygiene 2004;71(Suppl 2):2328. Morel 2005 Morel CM, Lauer JA, Evans DB. Cost effectiveness analysis of strategies to combat malaria in developing
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Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

countries. BMJ 2005;331(7528):1299. [DOI: 10.1136/ bmj.38639.702384.AE] RevMan 5.1 The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager 5.1 (RevMan). 5.1. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2011. Steketee 2009 Steketee RW, Eisele TP. Is the scale up of malaria intervention coverage also achieving equity?. PLoS One 2009;4(12):e8409. The Abdul Latif Jameel Poverty Action Lab The Abdul Latif Jameel Poverty Action Lab. Available from: http://www.povertyactionlab.org/evaluations?lters=type: evaluation. Massachusetts Institute of Technology. The Malaria in Pregnancy Library The Malaria in Pregnancy Library. Available from: http: //www.update-software.com/publications/malaria/. The Malaria in Pregnancy Consortium. Tugwell 2010 Tugwell P, Petticrew M, Kristjansson E, Welch V, Uefng E, Waters E, et al.Assessing equity in systematic reviews: realising the recommendations of the Commission on Social Determinants of Health. BMJ 2010;341:c4739. UN 2008 UN - Department of Public Information. End poverty 2015 - Millennium development goals; goal 6: Combat HIV-AIDS, malaria and other diseases. Available from: http://www.un.org/millenniumgoals/2008highlevel/pdf/ newsroom/Goal%206%20FINAL.pdf 2008.

WHO 2005a Roll Back Malaria, World Health Organization, UNICEF. World Malaria Report 2005. Available from: http:// www.rollbackmalaria.org/wmr2005/pdf/WMReportlr.pdf. 2005. WHO 2005b World Health Organization. Roll Back Malaria Partnership - Working Group for Scaling-up Insecticide-treated Netting. Scaling up Insecticide-treated Netting Programmes in Africa: A strategic Framework for Coordinated National Action. 2nd Edition. Revision 23. Available from: http: //www.rollbackmalaria.org/partnership/wg/wgitn/docs/ WINITNStrategicFramework.pdf. 2005. WHO 2007 Global Malaria Programme, Insecticide-Treated Mosquito Nets: a WHO Position Statement. World Health Organization 2007. WHO 2010a World Health Organization. Roll Back Malaria Partnership. RBM Info Sheets. Available from: http://rbm.who.int/ multimedia/rbminfosheets.html (accessed July 2010). WHO 2010b World Health Organization. WHO Fact Sheets: Malaria. Available from: http://www.who.int/mediacentre/ factsheets/fs094/en/ (accessed July 2010). WHO 2010c World Health Organization. WHO World Malaria Report 2010. Available from: http://whqlibdoc.who.int/ publications/2009/9789241563901eng.pdf 2010. Indicates the major publication for the study

APPENDICES

Appendix 1. Search strategy

MEDLINE

Database: Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) <1948 to Present> 1 Plasmodium.ti,ab. (29283) 2 exp malaria/ (42886) 3 Plasmodium/ or Plasmodium falciparum/ or Plasmodium malariae/ or Plasmodium ovale/ or Plasmodium vivax/ [related to malaria] (26963) 4 culicidae/ or exp anopheles/ [Mosquitos] (16478) 5 (culicidae or anopheles).ti,ab. (10590) 6 malaria$.ti,ab. (47331) 7 mosquito$.ti,ab. (21972) 8 (marsh fever or blackwater fever or paludism?).ti,ab. [synonyms for malaria] (186)
Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 10

9 Mosquito Control/ (5425) 10 or/1-9 [Malaria/Mosquitos] (86458) 11 Insecticide-Treated Bednets/ or Mosquito Nets/ (161) 12 (net? or netting or bednet$ or bed net$ or ITN? or LLIN?).ti,ab. (65749) 13 (bed$ adj2 screen$).ti,ab. (137) 14 curtain?.ti,ab. (807) 15 or/11-14 [Nets] (66658)

Results before lters: 16 10 and 15 [Malaria/Mosquito Control & Nets] (1990)

Results with lters 39 16 and (or/19,38) (650)

Filters

Cochrane RCT Filter - MEDLINE: sensitivity & precision maximizing (Handbook 6.4.d) (Higgins 2011) 17 (randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or clinical trials as topic.sh. or randomly.ab. or trial.ti. (729425) 18 exp animals/ not humans.sh. (3567219) 19 17 not 18 [Cochrane RCT Filter 6.4.d Sens/Precision Maximizing] (675254)

EPOC lter MEDLINE (v. 2.3) (to identify non RCT designs) 20 intervention?.ti. or (intervention? adj6 (clinician? or collaborat$ or community or complex or DESIGN$ or doctor? or educational or family doctor? or family physician? or family practitioner? or nancial or GP or general practice? or hospital? or impact? or improv$ or individuali?e? or individuali?ing or interdisciplin$ or multicomponent or multi-component or multidisciplin$ or multidisciplin$ or multifacet$ or multi-facet$ or multimodal$ or multi-modal$ or personali?e? or personali?ing or pharmacies or pharmacist? or pharmacy or physician? or practitioner? or prescrib$ or prescription? or primary care or professional$ or provider? or regulatory or regulatory or tailor$ or target$ or team$ or usual care)).ab. (112659) 21 (hospital$ or patient?).hw. and (study or studies or care or health$ or practitioner? or provider? or physician? or nurse? or nursing or doctor?).ti,hw. (609702) 22 demonstration project?.ti,ab. (1692) 23 (pre-post or pre test$ or pretest$ or posttest$ or post test$ or (pre adj5 post)).ti,ab. (47137) 24 (pre-workshop or post-workshop or (before adj3 workshop) or (after adj3 workshop)).ti,ab. (429) 25 trial.ti. or ((study adj3 aim?) or our study).ab. (438991) 26 (before adj10 (after or during)).ti,ab. (296123) 27 (quasi-experiment$ or quasiexperiment$ or quasi random$ or quasirandom$ or quasi control$ or quasicontrol$ or ((quasi$ or experimental) adj3 (method$ or study or trial or design$))).ti,ab,hw. [ML] (81245) 28 (time series adj2 interrupt $).ti,ab,hw. [ML] (584) 29 (time points adj3 (over or multiple or three or four or ve or six or seven or eight or nine or ten or eleven or twelve or month$ or hour? or day? or more than)).ab. (6022) 30 pilot.ti. (28825) 31 Pilot projects/ [ML] (64947) 32 (clinical trial or controlled clinical trial or multicenter study).pt. [ML] (555681) 33 (multicentre or multicenter or multi-centre or multi-center).ti. (21771) 34 random$.ti,ab. or controlled.ti. (581955) 35 (control adj3 (area or cohort? or compare? or condition or design or group? or intervention? or participant? or study)).ab. not (controlled clinical trial or randomized controlled trial).pt. [ML] (318012) 36 comment on.cm. or review.ti,pt. or randomized controlled trial.pt. [ML] (2428765)
Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 11

37 exp animals/ not humans.sh. (3567219) 38 (or/20-35) not (or/36-37) [EPOC Filter 2.3] (1709254)

HISTORY
Protocol rst published: Issue 6, 2011

CONTRIBUTIONS OF AUTHORS
PT conceived the idea for the systematic review. LAP drafted and revised the protocol with suggestions from EU, VW, ETG, JPP, PT, AA and MG who extensively reviewed the protocol and provided feedback on the draft.

DECLARATIONS OF INTEREST
AA has published papers on malaria drug quality in Africa and India. MG has been engaged in studies potentially eligible for our Cochrane Review. LAP, EU, VW, ETG, JPP and PT have no known conicts of interest.

SOURCES OF SUPPORT

Internal sources
No sources of support supplied

External sources
Knowledge Synthesis Grant, CIHR, Canada.

Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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