Search

Background India has a high typhoid fever burden. In 2022, the National Technical Advisory Group on Immunisation recommended introducing typhoid conjugate vaccine (TCV) into the Universal Immunisation Programme. Our study aims to identify research priorities to support ongoing TCV decision-making in India.Methods We identified 45 evidence factors for TCV decision-making in India by adapting WHO’s Evidence-to-Recommendation framework. We assigned an evidence gap score for each evidence factor from 0 (low) to 4 (high) based on the availability and sufficiency, quality, breadth and applicability of evidence identified in a literature review (end date 30 November 2023). We assigned each evidence factor an importance score based on the results of an online survey conducted among national immunisation stakeholders (n=22, 1 July 2023–31 October 2023), where they ranked the importance of seven WHO’s Evidence-to-Recommendation criteria and several evidence factors within them. We rescaled mean stakeholder rankings into importance scores from 0 (low) to 4 (high). Finally, we added the evidence gap score to the importance score and used the overall scores to identify research priorities to support ongoing TCV decision-making in India.Results We estimated the highest evidence priority scores for public perception of typhoid fever, vaccination budget impact, vaccine availability, socioeconomic impact, fiscal space, antimicrobial resistance tracking, typhoid fever mortality, public perception of TCV, immunisation managers’ acceptance and vaccine schedule preferences among caregivers.Conclusion By adapting WHO’s Evidence-to-Recommendation framework to the Indian context, we systematically identified several research priorities to support ongoing decision-making on TCV in India. These priorities will evolve as new research studies and questions emerge about the optimal scheduling, roll-out and implementation of TCV in India.

Abstract Introduction The introduction of a national evaluation of newborn screening for Severe Combined Immunodeficiency (SCID) in England triggered a change to the selective Bacillus Calmette-Guerin (BCG) vaccination programme delivery pathway, as this live attenuated vaccine is contraindicated in infants with SCID. The neonatal BCG vaccination programme is a targeted programme for infants at increased risk of tuberculosis and used to be offered shortly after birth. Since September 2021 the BCG vaccine is given to eligible infants within 28 days of birth, when the SCID screening outcome is available. We explore the experiences of those implementing the new pathway, and how they made sense of, engaged with, and appraised the change. Methods A mixed-methods evaluation was conducted between October 2022 and February 2023. This involved national online surveys with BCG commissioners and providers and qualitative semi-structured interviews with commissioners, providers, and Child Health Information System stakeholders in two urban areas. Survey data was analysed using descriptive statistics and interview data was analysed thematically. The data was triangulated using Normalization Process Theory as a guiding framework. Results Survey respondents (n = 65) and qualitative interviewees (n = 16) revealed that making sense of the new pathway was an iterative process. Some expressed a desire for more direction on how to implement the new pathway. The perceived value of the change varied from positive, ambivalent, to concerned. Some felt well-prepared and that improvements to data capture, eligibility screening, and accountably brought by the change were valuable. Others were concerned about the feasibility of the 28-day target, reductions in vaccination coverage, increased resource burden, and the outcome of the SCID evaluation. New collaborations and communities of practice were required to facilitate the change. Three main challenges in implementing the pathway and meeting the 28-day vaccination target were identified: appointment non-attendance; appointment and data systems; and staffing and resourcing. Feedback mechanisms were informal and took place in tandem with implementation. Conclusion The new NHS neonatal BCG service specification has created an effective structure for monitoring and managing the BCG vaccination programme, but further work is required to support delivery of the 28-day vaccination target and improve uptake rates.

Objective To illustrate an evidence-, theory- and person-based approach to codesign the COMMUNICATE films that support parental decision-making about the human papillomavirus (HPV) vaccine for their teenagers.Design Codesign study.Setting Localities covered by two immunisation teams in London and the south-west of England.Methods The intervention planning phase involved combining evidence from a literature review with qualitative interview data to identify barriers and facilitators to HPV vaccine uptake, as well as design features that should be incorporated within the COMMUNICATE films. The intervention development phase involved identifying guiding principles for the COMMUNICATE films, mapping behaviour change techniques onto the behaviour change wheel and codesigning the COMMUNICATE films. Feedback from users informed modifications to maximise acceptability and feasibility and to support behaviour change.Results The primary and secondary evidence highlighted important content to include within the COMMUNICATE films: emphasise the benefits of the HPV vaccine, provide transparent information about the safety profile and side effects and emphasise the universality and commonality of HPV infection. A series of scripts were used to guide 4 film shoots to create the content in multiple community languages with 16 participants, including vaccine-hesitant, ethnically diverse parents and professionals. Overall, participants were positive about the films. Potential messengers and ways the films could be distributed, identified by parents, include local social media networks or text messages from general practices. The need for information about the HPV vaccine to be shared by schools ahead of consent being sought was also raised.Conclusions By using an integrated approach to intervention development, this study has begun to address the need for an intervention to support vaccine-hesitant, ethnically diverse parents’ decision-making about the HPV vaccination programme. A future study to codesign, implement and evaluate a communication strategy for the COMMUNICATE films is planned.

Abstract Background The English schools-based human papillomavirus (HPV) vaccination programme has the potential to eliminate HPV-related cancers if high uptake is achieved. However, unmet information needs among some parents may contribute to persisting lower uptake among minority ethnic groups. Through this study we aimed to understand the information needs of vaccine-hesitant, ethnically diverse parents during decision-making about the HPV vaccine for their adolescent child, to inform the future development of tailored communication materials. Methods Recruitment was facilitated thorough healthcare and community organisations within London and the South West of England. Semi-structured interviews took place between April and August 2023. Thematic analysis was undertaken, assisted by NVivo software. Results Of the 29 parents interviewed, the majority were mothers (79%), belonged to a minority ethnic group (88%), and had an adolescent child unvaccinated against HPV (72%). Five of the interviews were undertaken in the participants’ primary language with translation support. Most parents interviewed had limited knowledge about the HPV vaccine and appeared conflicted as to whether vaccines could offer benefits to health. Misunderstanding around the potential of developing serious side-effects (e.g. fertility issues, developing cancer) were factors that could negatively impact decision-making by parents. Stigma associated with the sexual transmissibility of HPV did not always negatively impact decision-making. However, some parents chose not to vaccinate on the basis of perceptions of low risk and a preference to provide education about sexual behaviours to their adolescent child. Conclusions Tailoring communication materials to address misunderstandings could support informed decision-making by vaccine hesitant parents for their adolescent children to be vaccinated against HPV. Future communication materials about the HPV vaccine should highlight the benefits of protection against cancer to increase parents’ motivation for protect their adolescent child; provide accurate convincing information in relation to the excellent safety profile; and emphasise the importance of providing HPV vaccine at the recommended age, all alongside communicating the universality and commonality of HPV infection. Trial registration N/A.

Abstract Background A national SARS-CoV-2 vaccination programme was implemented in England from 8th December 2020, adopting a series of local level service delivery models to maximise rollout. The evidence base informing service design programme at inception was limited. We examined the real-world implementation of the programme through an assessment of sub-national providers’ and commissioners’ perspectives on the service delivery models used, to strengthen evidence on the acceptability, effectiveness and efficiency of the service delivery approaches used for SARS-CoV-2 vaccination in England or elsewhere. Methods Qualitative, cross-sectional analysis based on semi-structured interviews conducted with 87 stakeholders working in SARS-CoV-2 vaccination delivery across four regions in England. Localities were selected according to geography and population socio-economic status. Participants were purposively sampled from health service providers, commissioners and other relevant bodies. Interviews were conducted between February and October 2021, and transcripts were thematically analysed using inductive and deductive approaches. Results Various service delivery models were implemented over the course of the programme, beginning with hospital hubs and mass vaccination sites, before expanding to incorporate primary care-led services, mobile and other outreach services. Each had advantages and drawbacks but primary care-led models, and to some extent pharmacies, were perceived to offer a better combination of efficiency and community reach for equitable delivery. Common factors for success included availability of a motivated workforce, predictability in vaccine supply chains and strong community engagement. However, interviewees noted a lack of coordination between service providers in the vaccination programme, linked to differing financial incentives and fragmentated information systems, among other factors. Conclusion A range of delivery models are needed to enable vaccine rollout at pace and scale, and to mitigate effects on routine care provision. However, primary care-led services offer a tried-and-trusted framework for vaccine delivery at scale and pace and should be central to planning for future pandemic responses. Mass vaccination sites can offer delivery at scale but may exacerbate inequalities in vaccination coverage and are unlikely to offer value for money. Policymakers in England should prioritise measures to improve collaboration between service providers, including better alignment of IT systems.

Abstract Background Influenza vaccination is the key to prevent influenza-related disease, especially among high-risk populations. However, influenza vaccine uptake in China is low. This secondary analysis of a quasi-experimental trial aimed to understand factors associated with influenza vaccine uptake among children and older people stratified by funding context. Methods A total of 225 children (aged 0.5-8 years) and 225 older people (aged 60 years or above) were recruited from three clinics (rural, suburban and urban) in Guangdong Province. Participants were allocated into two groups based on funding contexts: a self-paid group (N = 150, 75 children and 75 older adults) in which participants paid full price for their vaccination; and a subsidized group (N = 300, 150 children and 150 older adults) in which varying levels of financial support was provided. Univariate and multivariable logistic regressions were conducted stratified by funding contexts. Results Overall, 75.0% (225/300) of participants in the subsidized group and 36.7% (55/150) in the self-paid group got vaccinated. Older adults had lower vaccination rates than children in both funding groups, while both age groups showed much higher uptake in the subsidized group than in the self-paid group (aOR = 5.96, 95% CI: 3.77–9.42, p = 0.001). In the self-paid group, having prior influenza vaccination history of children (aOR:2.61, 95%CI: 1.06–6.42) or older people (aOR:4.76, 95%CI: 1.08–20.90) was associated with increased influenza vaccine uptake compared to those who had no prior vaccination experiences in the family. While in the subsidized group, participants who got married or lived with partners (aOR = 0.32, 0.10–0.98) had lower vaccination uptake than single ones. Trust in providers’ advice (aOR = 4.95, 95%CI:1.99, 12.43), perceived effectiveness of the vaccine (aOR: 12.18, 95%CI: 5.21–28.50), and experienced influenza-like illnesses in the family in the past year (aOR = 46.52, 4.10, 533.78) were associated with higher vaccine uptake. Conclusions Older people had suboptimal vaccine uptake compared to children in both contexts and need more attention to enhance influenza vaccination. Tailoring interventions to different vaccine funding contexts may help improve influenza vaccination: In self-paid context, motivating people to accept their first ever influenza vaccination may be a promising strategy. In subsidized context, improving public confidence in vaccine effectiveness and providers’ advice would be useful.

Background: The English schools-based human papillomavirus (HPV) vaccination programme is routinely offered to all young people aged 12–13 years. The EDUCATE lesson was developed to overcome barriers to uptake related to unmet information needs by providing young people with information and answering questions they may have about the HPV vaccine. The resource comprises a PowerPoint presentation, interspersed with five short films and a guidance document for professionals delivering the lesson. Adopting public health research into practice is challenging and few papers describe the process. This paper reports the initial use of the EDUCATE resource in schools and the process involved in supporting wider implementation. Study design: Implementation and knowledge mobilisation. Methods: Five secondary schools supported implementation of the EDUCATE resource. Delivery took place during April and December 2022 and was observed in four schools, with feedback obtained from two school staff members and 15 young people. Alongside this, meetings were held with over 80 stakeholders with the aim of identifying possible policy levers to encourage use of the EDUCATE resource, and to enhance understanding of how wider scale and sustained impact can be achieved. Results: Overall, the resource was positively received by school staff and young people engaged well during the lesson. As a result of the stakeholder networking activities, the research team worked with the Personal, Social, Health and Economic (PSHE) Association to adapt the materials to meet their Quality Assessment and incorporate elements, such as more interactive activities, requested during the implementation study. Conclusion: The EDUCATE resource has the potential to change practice by enhancing information provision about the HPV vaccine in schools and supporting young people nationally to make informed decisions. Key learnings from the project include the importance of integrating input from target users at all stages of the research process, pragmatism in relation to evaluation research designs, and incentivising researchers to undertake translation activities through further funding and a greater focus on impact. Together, these can help facilitate the availability of public health resources and their adoption into ‘real-world’ practice.

A polio booster campaign targeting all children aged 1–9 was implemented across London between August–December 2022 as part of a national enhanced poliovirus incident response. Orthodox Jewish (OJ) children were particularly vulnerable to transmission due to disparities in childhood vaccination coverage and the transnational spread of poliovirus affecting linked populations in New York and Israel. This study aimed to evaluate how the polio booster campaign was tailored to increase uptake and enable access for OJ families in northeast and north central London boroughs, and the impact of the campaign on local-level vaccine inequities. Semi-structured in-depth interviews (n = 36) were conducted with participants involved in the implementation and delivery of the polio booster campaign, and OJ mothers. Site visits (n = 5) were conducted at vaccine clinics, and rapid interviews (n = 26) were held to explore parental perceptions of the poliovirus incident and childhood immunisations. Enablers to vaccination during the campaign included the production of targeted printed communications and offering flexible clinic times in primary care settings or complementary delivery pathways embedded in family-friendly spaces. Barriers included digital booking systems. Mothers reported being aware of the poliovirus incident, but the majority of those interviewed did not feel their children were at risk of contracting polio. Healthcare provider participants raised concerns that the vaccine response had limited impact on reducing disparities in vaccine uptake. While OJ families were recognised as a priority for public health engagement during the poliovirus incident response, this evaluation identified limitations in reducing transmission vulnerability during the booster campaign. Lessons for future campaign delivery include effectively conveying transmission risk and the urgency to vaccinate. Priorities for mitigating vaccine inequities include public engagement to develop messaging strategies and strengthening the capacity of primary care and complementary delivery pathways to serve families with higher-than-average numbers of children.

IntroductionInfluenza vaccination uptake among young children has been poor in China, but it is unclear how it changed during the COVID-19. This study aimed to investigate the uptake status and reasons of childhood influenza vaccination during the pandemic in China.MethodsA mixed-methods study combining a questionnaire survey and semi-structured interviews was conducted in Anhui, Shaanxi, and Guangdong provinces between September and November 2021. 2081 caregivers completed the valid questionnaire. 38 caregivers participated in interviews, and data were analyzed thematically, using deductive and inductive coding.ResultsA total of 2081 caregivers completed the valid questionnaire, and 38 caregivers participated in interviews. Among the caregivers, a total of 1796 were in the age group for high-risk groups in the 2019–2020 flu season, and 46.10% reported that their children received influenza vaccination in the 2019–2020 flu season; 43.63% said that they vaccinated their children against influenza in the 2020–2021 flu season. Many caregivers indicated that the adoption of nonpharmacologic interventions (NPIs) during COVID-19 reduced the risk of influenza infection for children. Most caregivers consider the severity of influenza to be low, and some confused the common cold with influenza. Meanwhile, some caregivers lack confidence in the vaccine’s effectiveness and importance. They thought that vaccines are not effective in preventing the constantly mutating virus. Despite clear perceptions about the severity of influenza and the effectiveness of the vaccine, we found that most caregivers did not receive any relevant medical information, and the communication about vaccines between caregivers and professional information sources, such as healthcare workers, is inadequate. Hence, caregivers have no scientific evidence to back up their perceptions. In terms of access to vaccination service, caregivers reported conflicts between time of vaccination service and their schedule, and the need for vaccine prices to be reduced.DiscussionTargeted interventions are needed to address caregivers’ lack of risk perception on influenza during COVID-19 and promote communication between caregivers and professional information sources. Extending vaccination service hours and increasing the number of vaccine clinics close to residential areas and expansion of financing sources for self-paid vaccination could facilitate the access to influenza vaccination service.

Childhood influenza vaccination coverage remains low in lower/middle-income countries. This systematic review aims to identify influencing factors around childhood influenza vaccination. A systematic literature review was conducted and included empirical studies with original data that investigated factors influencing childhood influenza vaccination. We searched MEDLINE, Web of Science, EMBASE, CINAHL Plus, Global Health, PsycINFO, and two Chinese databases, China Knowledge Resource Integrated Database and Chongqing VIP, using a combination of the key terms ‘childhood’, ‘influenza’, ‘vaccination’, and related syntax for all peer-reviewed publications published before December 2019. Thirty studies were included in the analysis. Childhood influenza vaccination was positively associated with caregivers’ knowledge of influenza vaccine, positive vaccine attitudes, self-efficacy, perceived susceptibility and severity of influenza, believing in the efficacy of influenza vaccine, the worry of getting sick, healthcare workers’ recommendations, and previous influenza vaccination experiences. Barriers included the fear of safety and side effects of the vaccine, as well as poor access to vaccination service. To improve childhood influenza vaccine uptake, health education is necessary to address caregivers’ lack of confidence on vaccine safety. Future studies are needed to investigate influencing factors around healthcare workers’ vaccination recommendation behaviors and the impact of contextual factors on public vaccination behaviors.

Abstract Some social settings such as households and workplaces, have been identified as high risk for SARS-CoV-2 transmission. Identifying and quantifying the importance of these settings is critical for designing interventions. A tightly-knit religious community in the UK experienced a very large COVID-19 epidemic in 2020, reaching 64.3% seroprevalence within 10 months, and we surveyed this community both for serological status and individual-level attendance at particular settings. Using these data, and a network model of people and places represented as a stochastic graph rewriting system, we estimated the relative contribution of transmission in households, schools and religious institutions to the epidemic, and the relative risk of infection in each of these settings. All congregate settings were important for transmission, with some such as primary schools and places of worship having a higher share of transmission than others. We found that the model needed a higher general-community transmission rate for women (3.3-fold), and lower susceptibility to infection in children to recreate the observed serological data. The precise share of transmission in each place was related to assumptions about the internal structure of those places. Identification of key settings of transmission can allow public health interventions to be targeted at these locations.

Plain English summary In England, young people are offered the human papillomavirus (HPV) vaccine in schools at age 12–13 years to prevent some types of cancer. Some young people have unanswered questions which may stop them getting vaccinated. We report how we developed a lesson about the HPV vaccine jointly with young people and professionals to improve how information about the HPV vaccine is given. First, we reviewed research studies and HPV vaccine information materials designed for young people. Then, we carried out interviews and workshops to ask about the best way to give a lesson and the most important information to include. We worked with creative designers to produce films and animations. Finally, we asked young people and professionals for feedback on the lesson materials. The lesson includes a PowerPoint presentation with five films and guidance for people leading the session. Key topics about the HPV vaccine to be covered were identified by young people. These included information about how vaccines work and ways to improve young people’s experience of having the HPV vaccine at school. We made changes to the information in the lesson to ensure that it was relevant to young people. We are now carrying out a study to find out how well the lesson is given and whether it can help more young people get the HPV vaccine if they want it.

BackgroundThe UK was the first country to launch a national pandemic COVID-19 vaccination programme, which was implemented swiftly despite significant vaccine supply constraints. The delivery strategy used a combination of mass vaccination sites operated by NHS secondary care providers and local sites led by Primary Care Networks, and local pharmacies. Despite nation-wide rollout, persistent gaps in coverage continued to affect particular populations, including ethnic minority and marginalised social groups.AimThe study examined sub-national immunisation commissioners and providers' perspectives on how the COVID-19 vaccine programme was operationalised, and how delivery strategies impacted inequalities in access to vaccination services and uptake. The study aimed to inform national programme implementation, sustainability and future pandemic preparedness.MethodsQualitative research was conducted in eight local NHS areas in 4 regions of England. Semi-structured interviews were performed with 82 sub-national NHS and public health vaccine providers and commissioners.ResultsEngland's COVID-19 vaccination programme was described as top down, centralised and highly political. The programme gradually morphed from a predominantly mass vaccination strategy into more locally driven and tailored approaches able to respond more effectively to inequalities in uptake. Over time more flexibility was introduced, as providers adapted services by "working around" the national systems for vaccine supply and appointment booking. The constant change faced by providers and commissioners was mitigated by high staff motivation and resilience, local collaboration and pragmatism. Opportunities for efficient implementation were missed because priority was given to achieving national performance targets at the expense of a more flexible sub-national tailored delivery.ConclusionPandemic vaccination delivery models need to be adapted for underserved and hesitant groups, working in collaboration with local actors. Learnings from the initial COVID-19 vaccine roll-out in England and elsewhere is important to inform future pandemic responses, in tailoring strategies to local communities, and improve large-scale vaccination programmes.

Objectives: A WHO Tailoring Immunization Programmes (TIP) evaluation was conducted in 2014-16 to investigate suboptimal childhood vaccination coverage in the north London Orthodox Jewish community. In 2021-22 a qualitative evaluation of the COVID-19 vaccine programme (CVP) was conducted in the same setting. This paper examines whether the issues identified by the TIP affected the CVP and what differences emerged between these two vaccine programme evaluations. Study design: Qualitative study. Methods: The CVP evaluation involved conducting 28 semi-structured interviews with public health professionals, Orthodox Jewish welfare and religious representatives, and household members in February-May 2021. The key considerations arising from the thematic analysis of this data was then compared systematically with the overarching findings from the TIP study. Results: The issues identified in the TIP study diverged and converged with results from the CVP evaluation: i) participants did not express concerns of unmet CVP information needs; ii) the social value of COVID-19 vaccines was influenced by international travel requirements; iii) in contrast to commissioning constraints noted to have limited flexible delivery of childhood immunisations in the TIP evaluation, the CVP was characterised by a flexible commissioning and delivery model. This model was facilitated by significant government investment as part of the COVID-19 pandemic response. Conclusions: The comparative analysis indicates that flexible vaccine commissioning and fit for purpose public health investment can influence how documented knowledge is translated into action. Implications are raised for how routine vaccination services are equipped to serve the needs of minority populations with historically suboptimal coverage levels.

Abstract Background Family planning (FP) has the potential to improve maternal and child health outcomes and to reduce poverty in sub-Saharan Africa. However, substantial unmet need for modern contraceptive methods (MCMs) persists in this region. Current literature highlights multi-level barriers, including socio-cultural norms that discourage the use of MCMs. This paper explores women’s choices and decision-making around MCM use and examines whether integrating FP services with childhood immunisations influenced women’s perceptions of, and decision to use, an MCM. Methods 94 semi-structured interviews and 21 focus group discussions with women, health providers, and community members (N = 253) were conducted in health facilities and outreach clinics where an intervention was delivering integrated FP and childhood immunisation services in Benin, Ethiopia, Kenya, Malawi and Uganda. Data were coded using Nvivo software and an analytical framework was developed to support interpretative and thematic analyses on women’s decision-making about MCM use. Results Most women shared the reproductive desire to space or limit births because of the perceived benefits of improved health and welfare for themselves and for their children, including the economic advantages. For some, choices about MCM use were restricted because of wider societal influences. Women’s decision to use MCMs was driven by their reproductive desires, but for some that was stymied by fears of side effects, community stigma, and disapproving husbands, which led to clandestine MCM use. Health providers acknowledged that women understood the benefits of using MCMs, but highlighted that the wider socio-cultural norms of their community often contributed to a reluctance to use them. Integration of FP and childhood immunisation services provided repeat opportunities for health providers to counter misinformation and it improved access to MCMs, including for women who needed to use them covertly. Conclusions Some women chose to use MCMs without the approval of their husbands, and/or despite cultural norms, because of the perceived health and economic benefits for themselves and for their families, and because they lived with the consequences of short birth intervals and large families. Integrated FP and childhood immunisation services expanded women’s choices about MCM use and created opportunities for women to make decisions autonomously.

Abstract Background Maternal and child health are key priorities among the Sustainable Development Goals, which include a particular focus on reducing morbidity and mortality among women of reproductive age, newborns, and children under the age of five. Two components of maternal and child health are family planning (FP) and immunisation. Providing these services through an integrated delivery system could increase the uptake of vaccines and modern contraceptive methods (MCMs) particularly during the post-partum period. Methods A realist evaluation was conducted in two woredas in Ethiopia to determine the key mechanisms and their triggers that drive successful implementation and service uptake of an intervention of integrated delivery of immunisations and FP. The methodological approach included the development of an initial programme theory and the selection of relevant, published implementation related theoretical frameworks to aid organisation and cumulation of findings. Data from 23 semi-structured interviews were then analysed to determine key empirical mechanisms and drivers and to test the initial programme theory. These mechanisms were mapped against published theoretical frameworks and a revised programme theory comprised of context-mechanism-outcome configurations was developed. A critique of theoretical frameworks for abstracting empirical mechanisms was also conducted. Results Key contextual factors identified were: the use of trained Health Extension Workers (HEWs) to deliver FP services; a strong belief in values that challenged FP among religious leaders and community members; and a lack of support for FP from male partners based on religious values. Within these contexts, empirical mechanisms of acceptability, access, and adoption of innovations that drove decision making and intervention outcomes among health workers, religious leaders, and community members were identified to describe intervention implementation. Conclusions Linking context and intervention components to the mechanisms they triggered helped explain the intervention outcomes, and more broadly how and for whom the intervention worked. Linking empirical mechanisms to constructs of implementation related theoretical frameworks provided a level of abstraction through which findings could be cumulated across time, space, and conditions by theorising middle-range mechanisms.

Background: In the UK, 4.7 million people are currently living with diabetes. This is projected to increase to 5 million by 2025. The direct and indirect costs of T1DM and T2DM are rising, and direct costs already account for approximately 10% of the National Health Service (NHS) budget.Objective: The aim of this review is to assess the economic models used in the context of NICE’s Technology Appraisals (TA) Programme of T1DM and T2DM treatments, as well as to examine their compliance with the American Diabetes Association’s (ADA) guidelines on computer modelling.Methods: A review of the economic models used in NICE’s TA programme of T1DM and T2DM treatments was undertaken. Relevant TAs were identified through searching the NICE website for published appraisals completed up to April 2021. The review also examined the associated Evidence Review Group (ERG) reports and Final Appraisal Documents (FAD), which are publicly accessible. ERG reports were scrutinised to identify major issues pertaining to the economic modelling. The FAD documents were then examined to assess how these issues reflected on NICE recommendations.Results: Overall, 10 TAs pertaining to treatments of T1DM and T2DM were identified. Two TAs were excluded as they did not use economic models. Seven of the 8 included TAs related to a novel class of oral antidiabetic drugs (OADs), gliflozins, and one to continuous subcutaneous insulin infusion (CSII) devices. There is a lack of recent, robust data informing risk equations to enable the derivation of transition probabilities. Despite uncertainty surrounding its clinical relevance, bodyweight/BMI is a key driver in many T2DM-models. HbA1c’s reliability as a predictor of hard outcomes is uncertain, chiefly for macrovascular complications. The external validity of T1DM is even less clear. There is an inevitable trade-off between the sophistication of models’ design, their transparency and practicality.Conclusion: Economic models are essential tools to support decision-making in relation to market access and ascertain diabetes technologies’ cost effectiveness. However, key structural and methodological issues exist. Models’ shortcomings should be acknowledged and contextualised within the framework of technology appraisals. Diabetes medications and other technologies should also be subject to regular and consistent re-appraisal to inform disinvestment decisions. Artificial intelligence could potentially enhance models’ transparency and practicality.

Introduction Persistent infection with HPV can result in cancers affecting men and, especially, women. Lower uptake exists by area and different population groups. Increasing parental confidence about, and adolescent access to, the universal HPV vaccination programme may help reduce inequalities in uptake. However, the evidence-base for interventions to address uptake for schools-based HPV vaccination programmes is currently lacking. This study protocol outlines how a multicomponent intervention to address this evidence gap will be codesigned with parents.Methods and analysis The proposed research will be undertaken in localities covered by two immunisation teams in London and the south-west of England. The ‘person-based approach’ to intervention development will be followed. In the first phase, an exploratory qualitative study will be undertaken with key stakeholders (n=8) and parents (n=40) who did not provide consent for their adolescent child to be vaccinated. During the interviews, parents’ views on ways to improve parental confidence about, and adolescents’ access to, HPV vaccination will be sought. The findings will be used to inform the co-design of a preliminary plan for a targeted, multicomponent intervention. In the second phase, at least two parent working groups (n=8) will be convened and will work with creative designers to co-design communication materials aimed at increasing parents’ confidence in vaccination. At least two workshops with each parent group will be organised to obtain feedback on the intervention plan and communication materials to ensure they are fit for purpose. These findings will inform a protocol for a future study to test the effectiveness of the intervention at increasing HPV vaccination uptake.Ethics and dissemination The National Health Services Research Ethics Service and London School of Hygiene & Tropical Medicine Observational / Interventions Research Ethics Committee provided approvals for the study (reference 22/SW/0003 & 26902, respectively). We will work with parent advisory groups to inform our dissemination strategy and co-present our findings (eg, at community events or through social media). We will disseminate our findings with academics and healthcare professionals through webinars and academic conferences, as well as peer-reviewed publications.

China’s immunization programme is relatively strong, with latest WHO-UNICEF monitoring rates for 2019 showing national vaccination coverage over 90%. However, vaccination coverage is heterogeneous, varying across geographic regions, rural–urban communities, and sub-populations. We conducted a qualitative study from a critical realist perspective, analyzing semi-structured interviews with 26 vaccination providers in three provinces, selected to represent regional socioeconomic disparities across Eastern, Central, and Western China. We analyzed data thematically, using deductive and inductive coding. Providers reported vaccination coverage in their areas had increased significantly, but remained lower among migrant and left-behind children. Main coverage determinants were child-related (i.e. gender, number, health status), caregiver-related (i.e. socioeconomic status, role, education level, ethnicity), institution-related (i.e. vaccinator numbers, information system, appointment process), and system-related (i.e. vaccine supply, intersectoral cooperation, vaccine ‘hesitancy’). Potentially effective measures to promote vaccination coverage included using routine maternal and child health-care visits for catch-up vaccination, providing additional health education, conducting follow-up family visits by village doctors, and requiring vaccination verification at school enrollment. This is the first qualitative study to examine potential determinants of low vaccination coverage in these areas of China. Findings can inform policies to strengthen the role of schools, develop the national immunization information system, and promote appointment apps. More consideration is needed to improve service quality and eliminating inequities, such as strengthening health education and service provision for migrant and left-behind children.

The uptake of non-EPI vaccines, such as influenza and pneumonia vaccines, are very low in China compared to other countries. In China, immunization services are provided by dedicated vaccination service providers (VSPs), and their recommendation is the key to improve vaccine uptake. This study explores VSP recommendation practices for non-EPI vaccines from a socio-ecological perspective. A mixed-methods study, combining a questionnaire survey and key informant interviews, was conducted in Anhui, Shaanxi, and Guangdong provinces. 555 VSPs completed the valid questionnaire, and 49 VSPs participated in in-depth interviews. Among the surveyed VSPs, 51.54% stated that they always or often recommended non-EPI vaccines in work, and the remaining half reported that they sometimes or never recommended non-EPI vaccines. Most VSPs interviewed communicated about non-EPI vaccines with the public in an informed style, not a presumptive one, and provided the public with all the decision-making latitude. The infrequent recommendation of non-EPI vaccines was widely prevalent among Chinese VSPs regardless of their individual characteristics, and was mainly driven by the interpersonal relationship, institutional arrangement, and public policy. Firstly, the VSPs were concerned about conflicts arising from the recommendation of self-paid vaccines and the risk of adverse reactions following vaccination. Secondly, high workloads left them insufficient time to communicate about non-EPI vaccines. Thirdly, there was no performance assessment or financial incentive for VSPs to recommend non-EPI vaccination, and their main responsibility was around EPI vaccination. Therefore, multi-level socio-ecological systems around non-EPI vaccination should be improved to optimize the communication between VSPs and the public, which include a better system of legal redress to resolve potential misunderstandings between the VSPs and the public, more effective workload management through whole-process health information system and strengthening public health workforce, and the introduction of performance assessment and appropriate incentives on non-EPI vaccination.

Young children aged 6–59 months are recommended as one of the priority groups for seasonal influenza vaccination in China. This study assessed influenza vaccination coverage and the factors associated with vaccination uptake among children in three Chinese provinces. In September 2021, 2081 caregivers with children

Background: General practices in England have continued to care for patients throughout the COVID-19 pandemic by instigating major changes to service delivery. Immunisations have continued, although the number of vaccines delivered initially dropped in April 2020. Aim: To evaluate how COVID-19 impacted the delivery of immunisations in London and identify innovative practices to inform future delivery, including for COVID-19 vaccines. Design & setting: A mixed-methods study of immunisation delivery in London, UK. Method: An online survey of London general practices was undertaken in May 2020 to produce a descriptive analysis of childhood immunisation delivery and identify innovative delivery models. Semi-structured interviews were conducted between August and November 2020 to explore innovative immunisation models, which were analysed thematically. Results: Sixty-eight per cent (n = 830) of London practices completed the survey and 97% reported having continued childhood immunisation delivery. Common delivery adaptations included spaced-out appointments, calling parents beforehand, and having only one parent attend. Forty-three practices were identified as having innovative models, such as delivering immunisations outside practice buildings or offering drive-through services. The thematic analysis of 14 semi-structured interviews found that, alongside adaptations to immunisation delivery within practices, existing local networks collaborated to establish new immunisation delivery models. Local population characteristics affected delivery and provide insights for large-scale vaccine deployment. Conclusion: Immunisations continued during 2020 with practices adapting existing services. New delivery models were developed by building on existing local knowledge, experiences, and networks. Immunisation delivery during the pandemic, including for COVID-19 vaccines, should be tailored to local population needs by building on primary care immunisation expertise.

Background: Ethnic and religious minorities have been disproportionately affected by SARS-CoV-2 worldwide. The UK strictly-Orthodox Jewish community has been severely affected by the pandemic. This group shares characteristics with other ethnic minorities including larger family sizes, higher rates of household crowding and relative socioeconomic deprivation. We studied a UK strictly-Orthodox Jewish population to understand transmission of COVID-19 within this community. Methods: We performed a household-focused cross-sectional SARS-CoV-2 serosurvey between late-October and early December 2020 prior to the third national lockdown. Randomly-selected households completed a standardised questionnaire and underwent serological testing with a multiplex assay for SARS-CoV-2 IgG antibodies. We report clinical illness and testing before the serosurvey, seroprevalence stratified by age and sex. We used random-effects models to identify factors associated with infection and antibody titres. Findings: A total of 343 households, consisting of 1,759 individuals, were recruited. Serum was available for 1,242 participants. The overall seroprevalence for SARS-CoV-2 was 64.3% (95% CI 61.6-67.0%). The lowest seroprevalence was 27.6% in children under 5 years and rose to 73.8% in secondary school children and 74% in adults. Antibody titres were higher in symptomatic individuals and declined over time since reported COVID-19 symptoms, with the decline more marked for nucleocapsid titres. Interpretation: In this tight-knit religious minority population in the UK, we report one of the highest SARS-CoV-2 seroprevalence levels in the world to date, which was markedly higher than the reported 10% seroprevalence in London at the time of the study. In the context of this high force of infection, all age groups experienced a high burden of infection. Actions to reduce the burden of disease in this and other minority populations are urgently required. Funding: This work was jointly funded by UKRI and NIHR [COV0335; MR/V027956/1], a donation from the LSHTM Alumni COVID-19 response fund, HDR UK, the MRC and the Wellcome Trust.

Abstract Background The English national health system experienced a major reorganisation in April 2013. This mixed methods study examined how staff managed to deliver the national immunisation programme within a new health infrastructure and explored the role and contribution of ‘partnership working’ to programme implementation. Methods A cross-sectional online questionnaire survey and a qualitative evaluation of an urban immunisation board were conducted in 2016. The questionnaire included 38 questions about immunisation responsibilities, collaboration, service evaluation and programme support. It was completed by 199 immunisation providers and 70 people involved in the management of the immunisation programme. The evaluation involved 12 semi-structured interviews, 3 observations of forum meetings and the review of forum meeting minutes. Descriptive statistical analysis of the survey data was performed using SPSS version 23 and qualitative data from both study components were uploaded to NVivo 11 and analysed thematically. Results Screening and Immunisation Teams were cited as responsible for programme leadership by 56% of survey respondents, but concerns were raised about their capacity to oversee larger geographies and a case made for decentralised accountability mechanisms. Only 44% of immunisation managers stated that poor performance was addressed adequately, and half of respondents thought that support given to providers was inadequate. Managers reported that partnership working improved the organisation (83%) and performance (78%) of immunisation, but stated it was more beneficial for information-sharing than implementation. A preference for a “locality working approach” with committees covering smaller health economies rather than larger commissioning areas was voiced. The immunisation board examined in the qualitative evaluation sought to achieve this by forging links with locally based steering committees, but also had to address internal challenges related to the role of the board and contribution of members to programmatic decision-making. Conclusions Key challenges in delivering the immunisation programme were rooted in the new health infrastructure, which had created greater distance between commissioners and providers and resulted in the fragmentation of programme responsibilities. Partnership working bridged gaps but more needs to be done to strengthen accountability mechanisms and ensure that collaborative activities are outcome oriented and sustainable in the shifting environment of reorganisation.

Gene drive research is progressing towards future field evaluation of modified mosquitoes for malaria control in sub-Saharan Africa. While many literature sources and guidance point to the inadequacy of individual informed consent for any genetically modified mosquito release, including gene drive ones, (outside of epidemiological studies that might require blood samples) and at the need for a community-level decision, researchers often find themselves with no specific guidance on how that decision should be made, expressed and by whom. Target Malaria, the Kenya Medical Research Institute and the Pan African Mosquito Control Association co-organised a workshop with researchers and practitioners on this topic to question the model proposed by Target Malaria in its research so far that involved the release of genetically modified sterile male mosquitoes and how this could be adapted to future studies involving gene drive mosquito releases for them to offer reflections about potential best practices. This paper shares the outcomes of that workshop and highlights the remaining topics for discussion before a comprehensive model can be designed.

Aim To co-produce with young people an educational package about the human papillomavirus (HPV) vaccine that is tailored to increase vaccine uptake in schools and populations with lower uptake.Introduction Persistent infection with HPV can result in cancers affecting men and especially women. From September 2019, the English-schools-based HPV vaccination programme was expanded to include young men (in addition to young women) aged 12–13 years. Some young people attending schools with lower uptake of the vaccine have unmet information needs. We hypothesise that mechanisms to address information needs and increase young people’s autonomy in consent procedures will result in higher uptake.Methods and analysis The Medical Research Council’s framework for development and evaluation of complex interventions will inform intervention development. Recruitment of young people aged 12–15 years and key stakeholders (National Health Service commissioners, school staff, immunisation nurses and youth workers/practitioners) will be facilitated through existing links with healthcare organisations, schools and youth organisations in areas with lower uptake of the HPV vaccination programme. The proposed research will comprise three phases: (1) a rapid review of adolescent immunisation materials and preliminary qualitative interviews with young people and key stakeholders, (2) theory development and co-production of HPV vaccine communication materials through an iterative process with young people and (iii) testing delivery mechanisms and acceptability of the educational package in four schools with lower uptake.Ethics and dissemination The University of Bristol’s Faculty of Health Sciences and London School of Hygiene and Tropical Medicine's Research Ethics Committees provided approvals for the study. A dissemination event for young people and key stakeholders and webinar with the National Immunisation Network will be organised. The study findings will be published in peer-reviewed journals and presented at conferences. Recommendations for a future larger scale study will be made.

Objectives To evaluate the usability and acceptability of an electronic consent pilot intervention for school-based immunisations and assess its impact on consent form returns and human papilloma virus (HPV) vaccine uptake.Design Mixed-methods theory-informed study applying qualitative methods to examine the usability and acceptability of the intervention and quantitative methods to assess its impact.Setting and participants The intervention was piloted in 14 secondary schools in seven London boroughs in 2018. Intervention schools were matched with schools using paper consent based on the proportion of students with English as a second language and students receiving free school meals. Participants included nurses, data managers, school-link staff, parents and adolescents.Interventions An electronic consent portal where parents could record whether they agreed to or declined vaccination, and nurses could access data to help them manage the immunisation programme.Primary and secondary outcome measures Comparison of consent form return rates and HPV vaccine uptake between intervention and matched schools.Results HPV vaccination uptake did not differ between intervention and matched schools, but timely consent form return was significantly lower in intervention schools (73.3% vs 91.6%, p=0.008). The transition to using electronic consent was not straightforward, while schools and staff understood the potential benefits, they found it difficult to adapt to new ways of working which removed some level of control from schools. Reasons for lower consent form return in e-consent schools included difficulties encountered by some parents in accessing and using the intervention. Adolescents highlighted the potential for electronic consent to by-pass their information needs.Conclusions The pilot intervention did not improve consent form return or vaccine uptake due to challenges encountered in transitioning to new working practice. New technologies require embedding before they become incorporated in everyday practice. A re-evaluation once stakeholders are accustomed with electronic consent may be required to understand its impact.

BackgroundRoutine immunization coverage has stagnated over the past decade and fallen short of WHO targets in Ethiopia. Community engagement strategies that reach beyond traditional health systems may reduce dropout and increase coverage. This evaluation assesses changes in immunization, postpartum family planning, and antenatal care coverage after implementation of an enhanced community engagement and defaulter tracing strategy, entitled "Fifth Child" project, across two districts in Benishangul-Gumuz Regional State (BGRS), Ethiopia.Methods and findingsA formative evaluation was conducted to examine the contribution of the strategy on immunization, postpartum family planning and antenatal care utilization in Assosa and Bambasi districts of BGRS. The quantitative findings are presented here. Routine and project-specific data were analyzed to assess changes in uptake of childhood vaccinations, postpartum family planning and antenatal care. Between January 2013 and December 2016, pentavalent-3 coverage increased from 63% to 84% in Assosa, and from 78% to 93% in Bambasi. Similarly, measles vaccine coverage increased from 77% to 81% in Assosa, and from 59% to 86% in Bambasi. Approximately 54% of all eligible infants across both woredas defaulted on scheduled vaccinations at least once during the period. Among defaulting children, 84% were identified and subsequently caught up on the vaccinations missed. Secondary outcomes of postpartum family planning and antenatal care also increased in both woredas.ConclusionThe "Fifth Child" project likely contributed to enhanced immunization performance and increased utilization of immunization and select perinatal health services in two woredas of BGRS. Further research is required in order to determine the impact of this community engagement strategy.

Recommendations by health professionals are important for vaccines that are not included in national schedules. This study explored health professionals’ perspectives on recommending non-scheduled (user-fee) childhood vaccinations in China, identifying key influences on professionals’ interactions with caregivers. We conducted individual semi-structured interviews with 20 health professionals from three provinces in China and analyzed data thematically using deductive and inductive coding. Health professionals from all three provinces were uncomfortable about being perceived to encourage parents to accept vaccines that incurred a fee. They provided information about non-scheduled vaccines but emphasized parental autonomy in decision-making. Rural parents were less aware of unscheduled vaccines and health professionals were more likely to encourage parents living in more affluent areas to consider these vaccines; varicella vaccine was preferred by parents as a way of preventing school absence. Economic incentives for unscheduled vaccines were given to staff at most study sites, although the amount given varied widely. These variations meant that staff receiving lower incentives were not motivated to promote non-scheduled vaccines if their workload was high; on the contrary, those receiving higher incentives were more likely to promote these vaccines. Health professionals need more guidance on how to recommend unscheduled vaccines in an informative, positive and appropriate manner. It is evident that parents’ awareness of these vaccines, and their economic circumstances, influence vaccinators recommendation practice. Economic incentives prompted health professionals to recommend non-scheduled vaccines; however, the application of such staff incentives varied widely in China. To adopt appropriate economic incentives, professional organizations should develop protocols for the use of incentives that account for their influence on recommendation practices. Suitable recommendation policy needs to balance basic salaries with performance-based incentives, consider overall workload, and include monitoring and evaluation of economic incentives.

Our study explored the effects of parental social integration on migrant children’s vaccination status in China. Using data obtained from the 2014 China Migrants Dynamic Survey, a total of 4915 participants were included in this study. Social integration was measured by economic, social, cultural, and internal identity. Univariate chi-square testing was used to calculate associations between all variables and migrant children’s vaccination status. Binary logistic regression was employed to calculate the impacts of social integration on migrant children’s vaccination status. In total, 94.7% of migrant children had complete vaccinations for their age. Migrants who had medical insurance, spoke the native language when communicating with locals, lived mainly with locals, and did not perceive discrimination were more likely to have their children completely vaccinated. Social integration was positively associated with migrant children’s vaccination status. Our study indicated that to improve vaccination coverage of migrant children, more policy support for migrant employment and housing, promotion of health services for migrants, and language support in health institutions is needed.

In China, there are two categories of vaccines available from the Chinese Center for Disease Control and associated public health agencies. Extended Program of Immunization (EPI) vaccines are government-funded and non-EPI vaccines are voluntary and paid for out-of-pocket. The government plans to transition some non-EPI vaccines to EPI in the coming years, which may burden public health system capacity, particularly in terms of budget, workforce, supply chains, and information systems. Our study explored vaccinator and caregiver perspectives on introducing non-EPI vaccines into routine immunization and perceived facilitators and barriers affecting this transition. We conducted a qualitative study from a realist perspective, analysing semi-structured interviews with 26 vaccination providers and 160 caregivers in three provinces, selected to represent regional socioeconomic disparities across Eastern, Central, and Western China. Data were analysed thematically, using deductive and inductive coding. Most participants were positive about adding vaccines to the national schedule. Candidate EPI vaccines most frequently recommended by participants were varicella, mumps vaccine, and hand–foot–mouth disease. Providers generally considered existing workspaces, cold-chain equipment, and funding sufficient, but described frontline staffing and vaccine information systems as requiring improvement. This is the first qualitative study to explore interest, barriers, and facilitators related to adding vaccines to China’s national schedule from provider and caregiver perspectives. Findings can inform government efforts to introduce additional vaccines, by including efforts to retain and recruit vaccine programme staff and implement whole-process data management and health information systems that allow unified nationwide data collection and sharing.

Background: We investigated pregnant women, community leaders, healthcare workers (HCWs) and programme managers’ perceptions of maternal vaccination in Kampala, Uganda. Methods: We conducted focus group discussions, key informant interviews and in-depth discussions with HCWs (3), community leaders (3), pregnant women (8) and programme managers (10) between November 2019 and October 2020. Data were analysed thematically. Results: Pregnant women, community leaders and some HCWs had limited maternal immunisation knowledge. There was confusion over what constitutes a vaccine. Pregnant women may not receive vaccines because of mistrust of government; use of expired vaccines; reliance on traditional medicine; religious beliefs; fear of side effects; HCWs attitudes; and logistical issues. The key facilitators of maternal vaccination were a desire to prevent diseases, positive influences from HCWs and information about vaccine side effects. Community leaders and some pregnant women highlighted that pregnant women do not make decisions about maternal vaccination independently and are influenced by different individuals, including other pregnant women, older people, partners, relatives (parents), community leaders, HCWs and the government. Conclusions: Our results indicate that public health messaging should target all community members, including partners and parents of pregnant women as well as HCWs, to improve knowledge of and confidence in maternal vaccines.

Access to vaccination information could influence public attitudes towards vaccination. This study investigated the number and types of vaccination-related information sources, and estimated their associations with vaccine confidence and hesitancy in China. In January 2019, we conducted a cross-sectional survey in China, and 2122 caregivers with children

Background: The 2016 Ugandan Demographic and Health Survey indicated that only 86% of children (aged 12–23 months) in northern Uganda had received the third dose of diphtheria-tetanus-pertussis vaccine (DTP3) and only 65% were fully immunised. To help close this gap, the International Rescue Committee developed a data-informed community engagement intervention, the Fifth Child Project, informed by a theory of change and including: (1) an mhealth tool used by health-facility-based staff and defaulter tracing forms used by community health workers aimed at improving data accuracy, (2) training of health workers in interpersonal skills, and (3) involvement of community leaders in planning vaccine outreaches. To test the impact of this intervention and examine its underlying hypothesis that a data-informed community engagement strategy will increase immunisation coverage, we conducted a cluster-randomised controlled trial with an embedded process evaluation. Methods: At baseline, a household two-stage cluster survey was conducted in 32 clusters (16 intervention and 16 control health facility catchment areas) from mid-June to mid-July, 2016. The survey collected information on vaccinations, caregivers’ interactions with community-based and facility-based health workers, and reasons for non-vaccination of eligible children. The primary outcome was DPT3 and measles coverage in children aged 9–23 months. Process evaluation activities included: quarterly monitoring reports, interviews, focus group discussions, and observations conducted in four intervention and two control clusters (March–April, 2017). The endline survey was conducted from Sept 19, 2017, to Oct 2, 2017. Findings: The sample included 916 households (935 children aged 9–23 months) in the intervention clusters and 881 households (897 children aged 9–23 months) in control clusters. Baseline estimates of immunisation coverage were similar for intervention and control arms. Both arms combined baseline coverage of DTP3 and measles vaccines using information from child immunisation cards, and caregiver recall was 78·3% (95% CI 76·0–81·5) and 64·6% (95% CI 60·9–67·3%), respectively. About 19% of children who received DTP1 had not received the measles vaccine in the intervention arm, compared with 21% of children in the control arm at baseline. The major barriers to complete immunisation included caregivers’ lack of awareness of immunisation schedule and vaccine stock-outs. Interpretation: Endline and process evaluation findings will be available in March 2018 and will provide a more complete assessment of the impact of the Fifth Child Project. Funding: International initiative for Impact Evaluation (3ie).

Objective There is significant interest in the role of digital health technology in enabling optimal monitoring of heart failure patients. To harness this potential, it is vital to account for users’ capacity and preferences in the development of technological solutions. We adopted an iterative approach focussed on learning from users’ interactions with a mobile-health monitoring system. Methods We used a participatory mixed methods research approach to develop and evaluate a mobile-health monitoring system. Fifty-eight heart failure patients were recruited from three health care settings in the UK and provided with Internet-enabled tablet computers that were wirelessly linked to sensor devices for blood pressure, heart rate and weight monitoring. One to two home visits were conducted with a subgroup of 29 participants to evaluate the usability of the system over a median follow-up period of six months. The thematic analysis of observational data and 45 interviews was informed by the domestication of technology theory. Results Our findings indicate that digital health technologies need to create and extend connections with health professionals, be incorporated into users’ daily routines, and be personalised according to users’ technological competencies and interest in assuming a proactive or more passive role in monitoring their condition. Conclusions Users' patterns of engagement with health technology changes over time and varies according to their need and capacity to use the technology. Incorporating diverse user experiences in the development and maintenance of mobile-health systems is likely to increase the extent of successful uptake and impacts on outcomes for patients and providers.