Peer-reviewed article

PROTOCOL: Use of community participation interventions to improve child immunisation in low- and middle-income countries: A systematic review and meta-analysis

Monica Jain, Mark Engelbert, Marie Moland Gaarder, Avantika Bagai, John E. Eyers · 28 Sept 2020

Abstract

Immunisation remains one of the most cost-effective interventions to prevent and control life-threatening infectious diseases. A study estimating the health and economic impact of routine immunisation for the period 2001–2020, found that introduction and/or increased coverage of vaccines are projected to avert over 14 million deaths, 350 million cases of illness, 8 million cases of long-term disability and 700 million disability adjusted life years (DALYs) (Ozawa et al., 2017). Yet rates of routine vaccination of children in low- and middle-income countries (LMICs) are strikingly low or stagnant, leading to a high disease burden and high infant and child mortality. In 2017, an estimated 19.9 million infants worldwide were not reached with routine immunisation services. Around 60% of these children live in 10 low-and-middle income countries, including Ethiopia, India, Nigeria and Pakistan ("Immunization coverage," 2018). Furthermore, national averages on immunisation coverage often obscure the underlying disparities within countries, and as a result, inequalities in immunisation often go unobserved or are underreported (Restrepo-Méndez et al., 2016). Therefore, there is an urgent need for interventions that improve immunisation of children in these countries. A number of innovative approaches to this problem have arisen in recent years. These approaches include strategies and technologies that enhance communities' participation in the planning, delivery, monitoring and uptake of routine vaccinations of children. These strategies have received considerable attention from funders, researchers, and practitioners (UNICEF, n.d.; WHO, 2008). However, there is at present a dearth of rigorous and systematic evidence about the effectiveness and cost-effectiveness of these interventions. There is therefore a need to make such evidence available to guide policymakers and public health practitioners in making informed decisions about these interventions. This review will systematically analyse the literature on this topic, conduct causal chain analysis to identify key facilitators and inhibitors of intervention success, and perform cost-effectiveness analysis to assess the value-for-money of enhancing community participation to improve immunisation of children. The review will focus on all interventions that use community participation or engagement to improve routine immunisation coverage of children. Communities may be identified in multiple ways. Writing in the Bulletin of the World Health Organization, Marston et al. (2016, p. 376) define communities as "groups of people who share common interests, concerns or identities in settings that are defined by geography, culture, administrative boundaries or geopolitical region or that are identified with joint activities, such as work or recreation." In this systematic review (SR), we define "communities" in reference to the administrative boundaries of the lowest level of the health service delivery system (or whatever level provides routine immunisation services in the local context). We prefer this over those defined by a geographical boundary, such as a village, as in some contexts the lowest level of health service delivery system provide services to multiple villages. For the purposes of our review, a community comprises a group of people who are served by a particular primary health facility (e.g., a subdistrict-level health centre). Thus, communities encompass a wide range of stakeholders, including caregivers, health service providers, and influential community members such as religious or other traditional leaders. Therefore, our review will include any intervention that is directed towards any of the above types of community members. Interventions that target higher levels of the health system—such as a programme to improve state-level officials' use of immunisation-related data—will be excluded. We define community participation as a process wherein communities are included, to various degrees, in planning, decision-making and implementation of activities that directly impact them (Stuart, 2017). The Spectrum of Public Participation, developed by the International Association for Public Participation (iap2.org), identifies five levels of public (community) participation, ranging from informing communities to empowering them (Table 1). The levels defined above refer to degrees of participation rather than types of intervention activities—indeed, these participation levels cut across intervention activities. For example, an intervention to inform or educate community members about the importance of immunisation could engage communities at the inform level (if communities are merely told that an informational campaign will be introduced in their area), at the empower level (if community members direct and manage all aspects of designing and implementing the informational campaign), or at any level in between. Similarly, interventions to motivate community members or increase health provider capacity could engage communities at any of these levels. In addition, a programme might also engage different community members at different levels (for different components of the same programme) or the level of engagement for the same set of participants may change over the course of a programme (Hardy, 2015). However, it is important to note that the participation spectrum does not assume one level of participation to be better than the others or imply that the deeper the level of engagement, the better. In other words, the spectrum does not classify the participation levels into a hierarchy. Relatedly, the quality of engagement is distinct from the level of involvement—that is, although the spectrum is arranged from less to more substantive, the fact that interactions are more substantive does not always mean they are of higher quality. Thus, an intervention at one of the higher levels of involvement may still be deficient in the way it incorporates community input and feedback because of poor design or implementation. For example, an intervention could make efforts to understand community concerns and consider them in decision-making, and thus be classified as an involve-level programme. But those efforts to understand may be weak, or community concerns may be considered but ultimately given minimal weight in decision-making. It is also important to note that the spectrum aims to capture a wide range of ways that intervention implementers can interact with communities. Although simply informing a community that an intervention is being implemented is arguably not participatory (and hence, interventions at the inform level are arguably not "community participation" interventions), we rely on the Spectrum of Public Participation because it is an established framework for understanding community engagement. In particular, including interventions at the inform level in our review will allow us to assess the hypothesis, implicit in the design of many community-engagement interventions, that informing communities is an insufficient level of engagement to effect change. A 2015 3ie scoping paper (Sabarwal et al., 2015) systematically mapped the literature on immunisation interventions and also consulted several programme managers and policy experts to understand why community participation could be the key to improving immunisation outcomes for children in areas where the coverage has stagnated or declined or that are hard to reach. The findings from the scoping study indicate that working with or engaging communities could help develop an understanding of the context, target population, problems and barriers, and lead to identification of contextually relevant solutions and desired outcomes, and mobilising community support for them. In addition, existing literature on behaviour change (Bicchieri & Xiao, 2009; Reynolds, Subašić, & Tindall, 2015) highlights the importance of recognising that individuals usually function under the influence of social norms, that is, they respond to their peers and community, and while activities such as information and education campaigns might have some influence, individuals might feel bound by collective decisions (Riedy, 2012). The role of peers and of social norms in shaping attitudes towards vaccination is particularly important given that vaccine hesitancy has been documented in countries of all income levels (although it takes very different forms in different countries; see Dubé, Gagnon, Nickels, Jeram, & Schuster, 2014). Moreover, there is systematic evidence from both high-income countries (HICs; O'Mara-Eves et al., 2013) and LMICs (De Buck et al., 2017) that community engagement can be an effective model of modifying health behaviours in particular. Hence, community engagement could be a very important determinant of success or failure of an intervention aimed at improving immunisation coverage. It is unlikely that any single theory of change would be able to capture all the different ways in which community participation (across the spectrum) affects immunisation outcomes. In particular, there is no strict correspondence between levels or types of engagement and specific intervention activities. For example, consider a proposed programme that aims to provide reminders to caregivers for immunisation. At less intensive levels of community participation, decisions related to the design and execution of the programme may have been undertaken by the sponsoring agency with limited inputs from the community. On the other hand, a similar programme can also result from conversations with the community, where members identify access to immunisation as a barrier because caregivers do not know when and where to take their children for immunisation, while at the same time the delivery of services is irregular. Additionally, the same participation process may also be leveraged to seek more substantive inputs from community members, including the frontline health workers, for designing the mode and content of reminders, targeting the hardest-to-reach households, and for mobilising the community at large. This example highlights how different intensity levels of community participation could give rise to the same activity involving reminders, which in turn could lead to improvement in access to immunisation services and an eventual increase in immunisation rates. Importantly, the theory of change linking community participation to immunisation outcomes does not specify a precise causal mechanism whereby specific intervention activities yield specific behavioural responses and outcomes. Rather, the theory assumes that different barriers to immunisation exist in different communities, and that different categories of activities will be best suited to addressing those barriers. The underlying logic of using community participation to increase immunisation coverage is that engaging communities can be an effective way to (a) identify activities that will address the immunisation barriers extant in that community, and (b) implement those activities in ways that are appropriate for the local context. Figure 1 provides a simplified theory of change for how various types of immunisation activities, grounded in different levels of community participation, might lead to improved immunisation outcomes for children. The activities are broadly classified as two types: beneficiary/community- and provider-oriented. These activities lead to outputs and outcomes related to improvement in demand for, delivery of, and access to immunisation services. This ultimately leads to improved timely uptake of vaccination(s) and an increase in full immunisation rates. As noted above, the precise causal mechanisms that begin with community engagement and end with improved immunisation rates will differ depending on the level of participation utilised and the nature of the activities selected; consequently, the theory of change does not depict the full details of each involvement level's mode of action. However, note that the theory does rely on the assumption that in order to produce the desired results, specific expertise, commitment, and resources will be required to engage the community effectively at the intended level of participation. The details of the theory of change—and in particular, how different levels of involvement will trigger different causal sequences—will be further developed in the course of the review and evidence synthesis. There are a number of existing SRs that address the effectiveness of interventions to increase immunisation coverage. However, none of these reviews are adequate for the purpose of guiding policymakers in deciding whether and how to pursue strategies that substantively involve various members of the community to address barriers all along the causal chain leading to vaccination delivery. We also believe it is important to have a review specific to LMICs. Many LMICs face similar barriers to achieving universal immunisation coverage, such as low rates of institutional births and poor infrastructure, which create logistical challenges for maintaining vaccination stocks and cold chains. In addition, health professionals in LMICs typically have lower literacy and skill levels which presents challenges for the delivery of quality immunisation services (Abejirinde, Ilozumba, Marchal, Zweekhorst, & Dieleman, 2018; Rowe et al., 2018). As these specific barriers are largely absent in HICs, reviews in which much of the evidence comes from HICs are of limited relevance to the needs of policymakers in LMICs. Below we list 10 existing reviews and briefly document why they do not already accomplish the goals of our proposed review; see "References" section for full references. Glenton et al. (2011): This review covers the use of lay health workers for increasing immunisation rates. While this overlaps with our proposed focus, our review will encompass other types of interventions that encourage community participation beyond those involving lay health workers (e.g., interventions aimed at community leaders and caregivers). In addition, only about half of the studies included in this review were conducted in LMICs. Kaufman et al. (2018): While the interventions covered in this review overlap with those in our proposed SR, there are key differences in scope. Kaufman et al.'s review covers only face-to-face interventions, whereas our review will include studies using any form of communicating with community members, including mass media and ICT (information and communication technology) modalities. In addition, 7 of 10 studies included in this review were conducted in HICs. Lassi and Bhutta (2015): Similar to our proposed review, the scope of Lassi et al.'s review is related to both community engagement as an intervention strategy and child health as an outcome. However, Lassi et al.'s review focuses on neonatal health and thus excludes many immunisation-related interventions. Mureed et al. (2015): The reporting in this review is limited so it is not clear what interventions were included in the scope of the review. In addition, the review did not include grey or non-English literature and lacks key policy-relevant components such as causal path analysis and cost-effectiveness information. Oyo-Ita et al. (2016): This review is comprehensive and recent, covering a broad range of interventions targeting DPT immunisation in LMICs. However, this review covers only interventions that target either caregivers or health service providers, whereas our review will also include interventions aimed primarily at other community members (such as religious or other community leaders). Thus, an intervention that aimed to improve immunisation coverage by enlisting influential community members (who may not have young children themselves) to spread information about the importance of immunisation would not meet the intervention criteria reported in Oyo-Ita et al.'s review, but would be included in ours. In addition, the literature in this area is expanding rapidly, so we anticipate that there will be a substantial amount of new evidence to be included in our review.1 Moreover, we plan to look at outcomes beyond DPT3 in our review and use an analysis framework focusing on levels of community participation which is different from the one used in this review. Pegurri et al. (2005): This review did not include grey literature and is over 10 years old. Ryman et al. (2008): This review is comprehensive and targets many of the same interventions as our proposed review (though without the specific focus on community-participation strategies). However, it is now 10 years old. Saeterdal et al. (2014): This review is relatively recent (and we understand an update will likely be published soon) and focuses specifically on interventions targeting communities. However, the interventions covered in this review address only one of the barriers to vaccination delivery, viz., lack of knowledge or information. In contrast, our review will include interventions aimed at barriers all along the causal chain leading to vaccine delivery. For example, interventions that aim to motivate (caregivers to vaccinate or health workers to strengthen outreach efforts) would not fall under Saeterdal et al.'s scope but would be included in ours. In addition, our review will include multifaceted interventions, whereas the Saeterdal et al. review will include such interventions only if the effects of the information/education component can be isolated.2 Thus, while Saeterdal et al.'s review did not include studies such as Bolam et al. (1998) or Ryman et al. (2011), these studies would likely meet the intervention criteria for our review.3 Shea et al. (2009): This review is nearly 10 years old and focuses exclusively on demand-side interventions, whereas our proposed review will cover both demand- and supply-side interventions. Even though immunisation coverage in LMICs has increased in recent years, many WHO-member countries still struggle to reach the target of 90% coverage for DPT and provide equitable access to life-saving vaccines (WHO, 2017a). Even with strengthened routine immunisation programmes, marginalised and vulnerable communities—which may also be geographically or socially secluded—are susceptible to being left out. Increasingly, international and national policy frameworks emphasise community participation or engagement to increase immunisation coverage and reach the hardest-to-reach (UNICEF, n.d.; WHO, 2015, 2017a, 2017b). This includes educating community members about immunisation and its importance, getting their feedback on developing viable solutions to improving immunisation services, motivating them to take action to improve coverage, collaborating with them to identify and resolve issues that contribute to low immunisation rates, and empowering them to develop and improve systems for immunisation service delivery that fit the local context. For instance, in 2011 the Ethiopian government launched a social mobilisation scheme, the Health Development Army, organising women from rural communities into volunteer networks to promote proper maternal and child health practices, including immunisation (Adamsu & Salama, 2014). Similarly, in 2014, the central government of India launched Mission Indradhanush (MI), which besides involving health administration at various levels, also involves community-level workers to enlist beneficiaries in areas where routine immunisation coverage is weak. MI is also mobilising communities using communication strategies to improve immunisation (Ministry of Health and Family Welfare, 2016). Several other countries and international organisations have also adopted similar policies to strengthen planning, delivery and uptake of health services in order to reach the children, especially in the most vulnerable and marginalised populations. Reflecting the demand for evidence on the effectiveness of these approaches, the Gates Foundation, in collaboration with the International Initiative for Impact Evaluation (3ie), has commissioned a series of impact evaluations on immunisation interventions with a focus on community participation.4 What evidence exists regarding the effectiveness of community participation interventions in improving routine immunisation coverage of children in LMICs? Is there evidence for heterogeneous effects of community participation strategies (i.e., does effectiveness vary by region, population, gender or programme implementation)? What intervention and implementation features are associated with relative success and failure in improving childhood routine immunisation outcomes? What are the contextual barriers to, and facilitators of, the effectiveness of community participation in routine immunisation interventions? What is the cost-effectiveness of different community participation interventions in improving children routine immunisation outcomes? In addition, we aim to assess whether there is any evidence of adverse effects of community participation interventions. Our review will follow Cochrane and Campbell Collaboration guidelines on conducting SRs. We will conduct a broad, systematic search, apply consistent criteria to the screening of studies for inclusion, and, where appropriate, synthesise studies through meta-analysis. We will present the findings of the review in forest plots and a "Summary of Findings" table. Items retrieved through the search will be imported to EPPI-Reviewer 4 and independently screened by two trained reviewers at the title/abstract and full-text levels. At the title/abstract level, we will use EPPI-Reviewer's machine learning and text mining features to prioritise citations that are likely to be included and to that are very unlikely to be included & & We will begin by screening to the machine learning and have EPPI-Reviewer order the to their of as by EPPI-Reviewer's We will set the EPPI-Reviewer to as we more and to to their of Thus, as we from the of the with low of will to be further to the of the we reach a where we we will the (i.e., those with an lower of than the We a of the to the of the screening will be conducted by two with through (and the lead making decisions on any We will document the screening process so that a and a of of studies can be in the review. (e.g., effects time series analysis We include both and because is often or in the of interventions. The above are all established for causal about an effects & There will be no on study We will not any on of members of the review and we will have the capacity to and from studies in and our search relevant studies in other we will to reviewers to and, if they meet our from these The review will include only studies that the effectiveness of an rather than studies of studies fall along a from to rather than into one or the other & et al., we will not have precise criteria to from effectiveness Rather, we will use a set of to guide the of whether to classify a study as an (and for The more a study the in the the will be the for it as an will be trained to any cases for further review and with the lead making decisions on any the study aim to how an intervention (e.g., or under as to how the intervention under (i.e., the that would in a of the the participants likely of the For example, are strict and criteria used to a relatively population, which may the of the Is the intervention primarily by researchers, rather than people who might be to the intervention under (e.g., health workers, community or the between and effectiveness is a we do not anticipate that reviewers will be able to which a study into on the or Thus, only the full-text screening will include related to this For this review, we will include studies at and to increase immunisation of children under five in LMICs a income is by its World at the time an intervention interventions that do not focus on immunisation outcomes for children (e.g., vaccination campaigns targeting will be excluded. We will also studies from high income countries, as the evidence from these countries will have limited to the contextual in LMICs. As for the while our review will focus on interventions targeting community members, interventions need not target the community as a it is that an intervention targets any of a community as defined only a of the in a study are (e.g., a study an effects on both childhood and we will include the study only if the study outcomes for the intervention involving some of community participation, where our of and are given above, will be for The types of relevant interventions but are not limited Interventions to promote community participation in the design of activities to encourage routine immunisation Interventions to promote community participation in designing and implementing routine immunisation delivery services Interventions to improve monitoring and mechanisms for routine immunisation-related activities and to improve routine immunisation outcomes for children Interventions that do not engage communities as defined above (i.e., people served by a given primary health will be excluded. will be interventions that do not involve any of the participation levels in the Spectrum of Participation (e.g., those that do not inform communities about an be included, studies assess at one of the primary or outcomes identified immunisation coverage specific immunisation coverage (e.g., DPT3 or coverage, uptake of vaccines DPT rates rates attitudes and related to immunisation in in health activities to immunisation to the primary health of interventions child child not from 1 to routine immunisation for children routine immunisation for children heterogeneous Although outcomes related to coverage and of vaccinations are the primary focus of this review, a wide range of outcomes are included to capture (e.g., demand for and access to immunisation and key effects (e.g., and of the primary outcomes. In addition, although some might differ in or no routine or might be a of each other 1 will be as the outcomes are wide ranging to for the differences and of in reporting them. health vaccination and will be considered