Two-factor factorial randomized multi-arm parallel controlled trial of four SARS-CoV-2 surveillance strategies in representative population sample points.

BACKGROUND: The SARS-CoV-2 pandemic is characterized by a constant risk of a rapid increase in infection burden due to the emergence of new variants with higher transmissibility and immune escape. Monitoring the SARS-CoV-2 pandemic has so far mainly relied on passive surveillance, which yields biased epidemiological measures due to the disproportionate number of undetected asymptomatic cases. In contrast, active surveillance could provide more accurate estimates of the true SARS-CoV-2 prevalence that help to forecast the evolution of the pandemic, enabling evidence-based decision-making. OBJECTIVE: The objective of this study was to compare four different approaches of active SARS-CoV-2 surveillance, focusing on feasibility and epidemiological outcomes. METHODS: The randomized, two-factor factorial, multi-arm parallel trial was conducted in 2020 in a German district with 700,000 inhabitants. The epidemiological outcome comprised the SARS-CoV-2 prevalence and its precision. The four study arms combined two factors: i) individuals versus households, ii) direct testing versus testing conditioned on symptom pre-screening. Individuals seven years and older were eligible. Altogether, 27,908 addresses from general population representative samples of 51 municipalities were randomly allocated to the arms and 15 consecutive recruitment weekdays. Data collection and logistics were highly digitized, a website in five languages enabled low-barrier registration and tracking of results. Gargle sample collection kits were sent by post. Participants collected a gargle sample at home and mailed it to the laboratory. Samples were analyzed with RT-LAMP, positive/weak results were confirmed with RT-qPCR. RESULTS: Recruitment took place between 18 November and 11 December 2020. The response rates in the four arms varied between 34% and 41%. The pre-screening classified 17% as COVID-19 symptomatic. Altogether, 4,232 persons without pre-screening and 7,623 participating in the pre-screening provided 5,351 gargle samples, of which 5,319 (99%) could be analyzed, yielding 17 confirmed SARS-CoV-2 infections and a combined prevalence of 0.36% (95% CI [0.14%; 0.59%]) in the arms without, respectively 0.05% (95% CI [0.00%; 0.108%]) with pre-screening (initial contacts only). In more detail, we found a prevalence of 0.31% (95% CI [0.06; 0.58]), respectively 0.35% (95% CI [0.09; 0.6], household members included), and lower estimates with pre-screening (0.07% (95% CI [0.0; 0.15], respectively with household members 0.02 (95% CI [0.0; 0.06]). Asymptomatic infections occurred in 3/11 positive cases with symptom data. The two arms without pre-screening performed best regarding effectiveness and accuracy. CONCLUSIONS: This study has shown that the combination of postal mailing of gargle sample kits as well as returning home-based self-collected liquid gargle samples and a subsequent analysis with high-sensitivity RT-LAMP is generally a feasible way to conduct active SARS-CoV-2 population surveillance without burdening routine diagnostic testing. Efforts to improve participation rates and to facilitate integration into the public health system may increase the potential to effectively monitor the course of the pandemic. CLINICALTRIAL: The trial was registered (30 November 2020) at the German Clinical Trials Register, registration number DRKS00023271. INTERNATIONAL REGISTERED REPORT: RR2-10.1186/s13063-021-05619-5.

Calculation, knowledge, and identity: Dimensions of trust when making COVID-19 vaccination choices in China.

Vaccine hesitancy threatens the response to the COVID-19 pandemic and to other infectious disease outbreaks globally. Fostering trust has been highlighted as a critical factor in addressing vaccine hesitancy and expanding vaccine coverage, but qualitative exploration of trust in the context of vaccination remains limited. We contribute to filling this gap by providing a comprehensive qualitative analysis of trust in the context of COVID-19 vaccination in China. We conducted 40 in-depth interviews with Chinese adults in December 2020. During data collection, trust emerged as a highly salient topic. Interviews were audio-recorded, transcribed verbatim, translated into English, and analyzed with a combination of inductive and deductive coding. Following established trust literature, we differentiate between three types of trust - calculation-based trust, knowledge-based trust, and identity-based trust - which we grouped across components of the health system, as informed by the WHO's building blocks. Our results highlight how participants attributed their level of trust in COVID-19 vaccines to their trust in the medical technology itself (based on assessing risks and benefits or previous vaccination experiences), the service delivery and health workforce (informed by past experiences with health providers and their role throughout the pandemic), and leadership and governance (drawing on notions of government performance and patriotism). Reducing negative impact from past vaccine controversies, increasing the credibility of pharmaceutical companies, and fostering clear communication are identified as important channels for facilitating trust. Our findings emphasize a strong need for comprehensive information on COVID-19 vaccines and increased promotion of vaccination by credible figures.

Kopfkino: Phases of quarantine among asymptomatic SARS-COV-2 carriers in Germany.

Although a majority of SARS-COV-2 diagnosis are asymptomatic, presymptimatic or minimally symptomatic, little has been described and understood about the illness careers of these individuals. This study explored the lived experience of a SARS-COV-2 diagnosis and subsequent quarantine among individuals in Germany who were diagnosed with SARS-COV-2 during the second wave of the pandemic (late 2020-early 2021), but whose diagnosis was unexpected due to a lack of a known contact, or the asymptomatic nature of their case at the time of diagnosis. In-depth interviews (n â€‹= â€‹22) were conducted by phone or video call, audio-recorded, and transcribed verbatim. Routine debriefings guided data collection and facilitated analysis, which followed a framework approach. Regardless of age, gender or socioeconomic status, data consistently demonstrated a diagnosis and quarantine career marked by five emotional phases: overconfidence, shock and denial, coming to grips and asking questions, enduring, and cautious optimism as quarantine ended. These experiences suggest that providing trustworthy, easily accessible information regarding certain key aspects of the post diagnosis and quarantine period could benefit patients in terms of reducing stress, understanding the consequences of a diagnosis and mitigating foreseeable challenges in terms of personal, logistical and emotional issues. Follow-up research with providers and public health bureaus could inform how to best tailor such messaging for clients who experience an unexpected diagnosis.

From disgusting and complicated to simple and brilliant: Implementation perspectives and lessons learned from users and rejectors of mail-in SARS-CoV-2 gargle tests.

Background: Despite the important role of testing as a measure against the COVID-19 pandemic, user perspectives on SARS-CoV-2 tests remain scarce, inhibiting an improvement of testing approaches. As the world enters the third year of the pandemic, more nuanced perspectives of testing, and opportunities to expand testing in a feasible and affordable manner merit consideration. Methods: Conducted amid the second pandemic wave (late 2020-early 2021) during and after a multi-arm trial evaluating SARS-CoV-2 surveillance strategies in the federal state Baden-Württemberg, Germany, this qualitative sub-study aimed to gain a deeper understanding of how test users and test rejectors perceived mail-in SARS-CoV-2 gargle tests. We conducted 67 semi-structured in-depth interviews (mean duration: 60 min) via telephone or video call. Interviews were audio-recorded, transcribed verbatim and analyzed inductively using thematic analysis. The Consolidated Framework for Implementation Research guided the findings' presentation. Results: Respondents generally described gargle sampling as simple and comfortable. However, individual perceptions of the testing method and its feasibility varied widely from disgusting and complicated to simple and brilliant. Self-sampling was appreciated for lowering infection risks during testing, but also considered more complex. Gargle-sampling increased participants' self-efficacy to sample correctly. Communication (first contact, quantity and content of information, reminders, support system) and trust (in the study, its institutional affiliation and test method) decisively influenced the intervention's acceptability. Conclusion: User-driven insights on how to streamline testing include: consider communication, first impressions of tests and information as key for successful mail-in testing; pay attention to the role of mutual trust between those taking and administering tests; implement gargle self-sampling as a pleasant alternative to swab testing; offer multiple test methods to increase test up-take.

From disgusting and complicated to simple and brilliant: Implementation perspectives and lessons learned from users and rejectors of mail-in SARS-CoV-2 gargle tests

Background Despite the important role of testing as a measure against the COVID-19 pandemic, user perspectives on SARS-CoV-2 tests remain scarce, inhibiting an improvement of testing approaches. As the world enters the third year of the pandemic, more nuanced perspectives of testing, and opportunities to expand testing in a feasible and affordable manner merit consideration. Methods Conducted amid the second pandemic wave (late 2020–early 2021) during and after a multi-arm trial evaluating SARS-CoV-2 surveillance strategies in the federal state Baden-Württemberg, Germany, this qualitative sub-study aimed to gain a deeper understanding of how test users and test rejectors perceived mail-in SARS-CoV-2 gargle tests. We conducted 67 semi-structured in-depth interviews (mean duration: 60 min) via telephone or video call. Interviews were audio-recorded, transcribed verbatim and analyzed inductively using thematic analysis. The Consolidated Framework for Implementation Research guided the findings' presentation. Results Respondents generally described gargle sampling as simple and comfortable. However, individual perceptions of the testing method and its feasibility varied widely from disgusting and complicated to simple and brilliant. Self-sampling was appreciated for lowering infection risks during testing, but also considered more complex. Gargle-sampling increased participants' self-efficacy to sample correctly. Communication (first contact, quantity and content of information, reminders, support system) and trust (in the study, its institutional affiliation and test method) decisively influenced the intervention's acceptability. Conclusion User-driven insights on how to streamline testing include: consider communication, first impressions of tests and information as key for successful mail-in testing;pay attention to the role of mutual trust between those taking and administering tests;implement gargle self-sampling as a pleasant alternative to swab testing;offer multiple test methods to increase test up-take.

Deliberation, context, emotion and trust - understanding the dynamics of adults' COVID-19 vaccination decisions in Germany.

BACKGROUND: Willingness to vaccinate against coronavirus disease 2019 (COVID-19), which is vital to successful vaccination campaigns, is wavering and suboptimal. In Germany, quantitative research highlighted concerns regarding the safety and efficacy of COVID-19 vaccines as barriers to uptake, but qualitative insights regarding individuals' decisions about COVID-19 vaccines and how personal perceptions reflect or refute existing behavioral theories are lacking. METHODS: To identify how individuals make COVID-19 vaccination decisions within real-life contexts, we conducted 33 semi-structured, in-depth qualitative interviews with individuals in Germany between March and April 2021 using maximum variation sampling, focusing on perceptions of COVID-19 vaccines. Analysis, informed by a framework approach, began in the field via debriefings and was amplified upon the conclusion of data collection. RESULTS: Four interconnected themes (deliberation, context, emotion, trust) shaped respondents' decisions about vaccination. Personal deliberation regarding benefits and risks of vaccines and perceptions of the broader social and political context sparked a spectrum of emotions that underpinned vaccination decisions. Trust in science and researchers emerged as a powerful protective factor facilitating the decision to get vaccinated even amidst a rapidly changing context and disconcerting information. CONCLUSIONS: Our findings add to ongoing debates about the breadth of vaccination decisions by highlighting how respondents are influenced by their perceptions of the political context and the emotional heft of their decisions. The role of cognitive evaluation, context, and emotions mirrors other decision-making frameworks, particularly the Risk as Feelings Theory. We extend on the elements of this theory by highlighting trust as a protective factor when making decisions particularly in highly uncertain contexts. Success of vaccination campaigns, more important than ever as new variants of COVID-19 emerge, is interwoven with an ability to bolster trust in science. Communicating public-health decisions and information about vaccines transparently without instilling fear offers promising chances to strengthen public trust in COVID-19 vaccines. TRIAL REGISTRATION: German Clinical Trials Register ( DRKS00024505 ).

Bargaining and gendered authority: a framework to understand household decision-making about childhood vaccines in the Philippines.

INTRODUCTION: Targeted vaccination promotion efforts aimed at building vaccine confidence require an in-depth understanding of how and by whom decisions about vaccinating children are made. While several studies have highlighted how parents interact with other stakeholders when discussing childhood vaccination, less is known about the way in which vaccination uptake is negotiated within households. METHODS: We conducted 44 in-depth interviews with caregivers of children under five in the Philippines who had delayed or refused vaccination. Interviews were conducted between August 2020 and March 2021 and were audio-recorded, transcribed verbatim and translated into English. Notions of intra-household vaccination bargaining emerged early during systematic debriefings and were probed more pointedly throughout data collection. RESULTS: Parents as well as paternal and maternal families proved to be dominant stakeholders in intra-household bargaining for childhood vaccination. Although bargaining among these stakeholders was based on engrained, gender-based power imbalances, disadvantaged stakeholders could draw on a range of interrelated sources of bargaining power to nevertheless shape decision-making. Sources of bargaining power included, in descending order of their relevance for vaccination, (1) physical presence at the household (at the time of vaccination decision-making), (2) interest in the topic of vaccination and conviction of one's own position, (3) previous vaccination and caregiving experience, and (4) access to household resources (including finances). The degree to which each household member could draw on these sources of bargaining power varied considerably over time and across households. CONCLUSION: Our findings highlight how bargaining due to intra-household disagreement coins decisions regarding childhood vaccination. Considering the risks for public health associated with vaccine hesitancy globally, we advocate for acknowledging intra-household dynamics in research and practice, such as by purposefully targeting household members with decision-making capacity in vaccination promotion efforts, aligning promotion efforts with available bargaining capacity or further empowering those convinced of vaccination.

Animated, video entertainment-education to improve vaccine confidence globally during the COVID-19 pandemic: an online randomized controlled experiment with 24,000 participants.

BACKGROUND: Science-driven storytelling and entertainment-education (E-E) media demonstrate potential for promoting improved attitudes and behavioral intent towards health-related practices. Months after the outbreak of coronavirus disease 2019 (COVID-19), emerging research highlights the essential role of interventions to improve public confidence in the COVID-19 vaccine. To improve vaccine confidence, we designed three short, animated videos employing three research-informed pedagogical strategies. These can be distributed globally through social media platforms, because of their wordless and culturally accessible design. However, the effectiveness of short, animated storytelling videos, deploying various pedagogic strategies, needs to be explored across different global regions. METHODS/DESIGN: The present study is a multi-site, parallel group, randomized controlled trial (RCT) comparing the effectiveness of (i) a storytelling-instructional-humor approach, (ii) a storytelling-analogy approach, (iii) a storytelling-emotion-focused approach, and (iv) no video. For our primary outcomes, we will measure vaccine hesitancy, and for secondary outcomes, we will measure behavioral intent to seek vaccination and hope. Using online platforms, we will recruit 12,000 participants (aged 18-59 years) from the USA and China, respectively, yielding a total sample size of 24,000. DISCUSSION: This trial uses innovative online technology, reliable randomization algorithms, validated survey instruments, and list experiments to establish the effectiveness of three short, animated videos employing various research-informed pedagogical strategies. Results will be used to scientifically support the broader distribution of these short, animated video as well as informing the design of future videos for rapid, global public health communication. TRIAL REGISTRATION: German Clinical Trials Register DRKS #00023650 . Date of registration: 2021/02/09.

Misinformation, infighting, backlash, and an 'endless' recovery; policymakers recount challenges and mitigating measures after a vaccine scare in the Philippines.

BACKGROUND: Vaccine scares undermine longstanding global health achievements. Remarkably little data has documented the lived experiences of policymakers working amidst vaccine scares and navigating their fallout. As a result, chances and challenges of large-scale national recuperation efforts are poorly understood. OBJECTIVE: This study aims to explore the perspectives of policymakers involved in ongoing efforts to boost vaccine confidence in the Philippines following a 2017 Dengvaxia scare and the current COVID-19 pandemic. METHODS: Between August and November 2020, we conducted 19 semi-structured narrative interviews with purposively selected policymakers from governmental agencies and non-governmental organizations in the Philippines. Interviews were conducted online, transcribed, and analyzed following the tenets of reflexive thematic analysis. RESULTS: We present results as an emerging model that draws on a chronology conveyed by policymakers in their own words. The Dengvaxia scare proved 'a decisive wedge' that splintered Filipino society and pitted governmental agencies against one another. The scare stoked distorted vaccination narratives, which were 'accelerated rapidly' via social media, and ignited feelings of uncertainty among policymakers of how to convey clear, accurate health messaging and how to prevent drops in care-seeking more broadly. CONCLUSIONS: Efforts to regain trust placed exceptional burdens on an already-strained health system. Respondent-driven recommendations on how to reinforce vaccine confidence and improve vaccination rollout include: developing clear vaccine messages, fostering healthcare providers' and policymakers' communication skills, and rebuilding trust within, toward and across governmental agencies. Further research on how to build enabling environments and rebuild trust in and across institutions remains paramount.

Highly valued despite burdens: Qualitative implementation research on rapid tests for hospital-based SARS-CoV-2 screening.

Antigen-based rapid diagnostic tests (RDTs) for SARS-CoV-2 have good reliability and have been repeatedly implemented as part of pandemic response policies, especially for screening in high-risk settings (e.g., hospitals and care homes) where fast recognition of an infection is essential. However, evidence from actual implementation efforts and associated experiences is lacking. We conducted a qualitative study at a large tertiary care hospital in Germany to identify step-by-step processes when implementing RDTs for the screening of incoming patients, as well as stakeholders' implementation experiences. We relied on 30 in-depth interviews with hospital staff (members of the regulatory body, department heads, staff working on the wards, staff training providers on how to perform RDTs, and providers performing RDTs as part of the screening) and patients being screened with RDTs. Despite some initial reservations, RDTs were rapidly accepted and adopted as the best available tool for accessible and reliable screening. Decentralized implementation efforts resulted in different procedures being operationalized across departments. Procedures were continuously refined based on initial experiences (e.g., infrastructural or scheduling constraints), pandemic dynamics (growing infection rates), and changing regulations (e.g., screening of all external personnel). To reduce interdepartmental tension, stakeholders recommended high-level, consistently communicated and enforced regulations. Despite challenges, RDT-based screening for all incoming patients was observed to be feasible and acceptable among implementers and patients, and merits continued consideration in the context of high infection and stagnating vaccination rates.

Attitudes Toward the Global Allocation of Chinese COVID-19 Vaccines: Cross-sectional Online Survey of Adults Living in China.

BACKGROUND: COVID-19 vaccines are in short supply worldwide. China was among the first countries to pledge supplies of the COVID-19 vaccine as a global public product, and to date, the country has provided more than 600 million vaccines to more than 200 countries and regions with low COVID-19 vaccination rates. Understanding the public's attitude in China toward the global distribution of COVID-19 vaccines could inform global and national decisions, policies, and debates. OBJECTIVE: The aim of this study was to determine the attitudes of adults living in China regarding the global allocation of COVID-19 vaccines developed in China and how these attitudes vary across provinces and by sociodemographic characteristics. METHODS: We conducted a cross-sectional online survey among adults registered with the survey company KuRunData. The survey asked participants 31 questions about their attitudes regarding the global allocation of COVID-19 vaccines developed in China. We disaggregated responses by province and sociodemographic characteristics. All analyses used survey sampling weights. RESULTS: A total of 10,000 participants completed the questionnaire. Participants generally favored providing COVID-19 vaccines to foreign countries before fulfilling domestic needs (75.6%, 95% CI 74.6%-76.5%). Women (3778/4921, 76.8%; odds ratio 1.18, 95% CI 1.07-1.32; P=.002) and those living in rural areas (3123/4065, 76.8%; odds ratio 1.13, 95% CI 1.01-1.27; P=.03) were especially likely to hold this opinion. Most respondents preferred providing financial support through international platforms rather than directly offering support to individual countries (72.1%, 95% CI 71%-73.1%), while for vaccine products they preferred direct provision to relevant countries instead of via a delivery platform such as COVAX (77.3%, 95% CI 76.3%-78.2%). CONCLUSIONS: Among our survey sample, we found that adults are generally supportive of the international distribution of COVID-19 vaccines, which may encourage policy makers to support and implement the distribution of COVID-19 vaccines developed in China worldwide. Conducting similar surveys in other countries could help align policy makers' actions on COVID-19 vaccine distribution with the preferences of their constituencies.

How can human-centered design build a story-based video intervention that addresses vaccine hesitancy and bolsters vaccine confidence in the Philippines? A mixedmethod protocol for project SALUBONG.

INTRODUCTION: Since the onset of a dengue vaccine controversy in late 2017, vaccine confidence has plummeted in the Philippines, leading to measles and polio outbreaks in early 2019. This protocol outlines a human-centered design (HCD) approach to co-create and test an intervention that addresses vaccine hesitancy (VH) via narrative and empathy with and among families and healthcare workers. METHODS AND ANALYSIS: 'Salubong' is a Filipino term that means to welcome someone back into one's life, reinforcing notions of family ties and friendships. We apply this sentiment to vaccines. Following the phases of HCD, guided by a theoretical framework, and drawing from locally held understandings of faith and acceptance, we will conduct in-depth interviews (IDIs) and focus group discussions (FGDs) in rural and urban Filipino communities that witnessed dramatic increases in measles cases in recent years. During qualitative engagements with caretakers, providers, and policymakers, we will collect narratives about family and community perceptions of childhood vaccinations, public health systems and opportunities to restore faith. IDIs and FGDs will continuously inform the development of (and delivery mechanisms for) story-based interventions. Once developed, we will test our co-created interventions among 800 caretakers and administer a VH questionnaire prior to and immediately following the intervention encounter. We will use the feedback gained through the survey and Kano-style questionnaires to further refine the intervention. Considering the data collection challenges posed by the ongoing COVID-19 pandemic, we have developed workarounds to conduct data collection primarily online. We will use systematic online debriefings to facilitate comprehensive participation of the full research team. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Institutional Review Board of the Research Institute for Tropical Medicine (number 2019-44) and Ethical Commission of Heidelberg University, Faculty of Medicine (S-833/2019). Study findings will be disseminated in scientific conferences and published in peer-reviewed journals.

Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions.

Individual informed consent is a central requirement for clinical research on human subjects, yet whether and how consent requirements should apply to health policy experiments (HPEs) remains unclear. HPEs test and evaluate public health policies prior to implementation. We interviewed 58 health experts in Tanzania, Bangladesh and Germany on informed consent requirements for HPEs. Health experts across all countries favored a strong evidence base, prior information to the affected populations, and individual consent for 'risky' HPEs. Differences pertained to individual risk perception, how and when consent by group representatives should be obtained and whether HPEs could be treated as health policies. The study adds to representative consent options for HPEs, yet shows that more research is needed in this field - particularly in the present Covid-19 pandemic which has highlighted the need for HPEs nationally and globally.

Experiences with opt-in, at-home screening for SARS-CoV-2 at a primary school in Germany: an implementation study.

Background: Over the course of the pandemic, many countries have repeatedly closed schools and shifted schoolchildren to remote learning. However, evidence for negative mental and physiological health consequences of such measures for schoolchildren is increasing, highlighting the need for evidence-based recommendations on how to safely reopen schools. This study aims to assess implementation experiences, acceptability and feasibility of opt-in, at-home SARS-CoV-2 screening using rapid diagnostic tests (RDTs) to facilitate safe face-to-face teaching during a pandemic. Methods: We present data from a prospective study implementing an RDT-based screening programme at a primary school in southwest Germany. In addition to quantitative data collected to assess screening diagnostic yield (number of participants, tests handed out to participants, positive RDT results reported), we conducted qualitative in-depth interviews with participating pupils, parents and school stakeholders to elicit implementation experiences and screening perceptions. Results: The screening intervention was highly accepted and appreciated among participants; no screening-associated positive RDT was reported over the duration of the study. Self-testing at home before coming to school was feasible, but more positive consequences of screening participation (eg, easing of mask mandates) besides a personal feeling of safety would have been appreciated across respondent groups. Participants preferred home-based RDTs over some other measures, particularly mask mandates. Despite the RDTs being licensed as self-tests in Germany, additional training can help avoid mistakes, and ensuring intervention ownership and improving pre-implementation communication can facilitate buy-in. Conclusions: Antigen-RDT-based SARS-CoV-2 screening programmes relying on self-testing at home are a feasible and acceptable supplement to the public health toolbox to facilitate a safe return to face-to-face teaching at schools. Trial registration number: DRKS00024845.

Nudging toward vaccination: a systematic review.

BACKGROUND: Vaccine hesitancy (VH) and the global decline of vaccine coverage are a major global health threat, and novel approaches for increasing vaccine confidence and uptake are urgently needed. 'Nudging', defined as altering the environmental context in which a decision is made or a certain behaviour is enacted, has shown promising results in several health promotion strategies. We present a comprehensive synthesis of evidence regarding the value and impact of nudges to address VH. METHODS: We conducted a systematic review to determine if nudging can mitigate VH and improve vaccine uptake. Our search strategy used Medical Subject Headings (MeSH) and non-MeSH terms to identify articles related to nudging and vaccination in nine research databases. 15 177 titles were extracted and assessed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The final list of included articles was evaluated using the Mixed Methods Appraisal Tool and the Grading of Recommendations, Assessment, Development and Evaluations framework. FINDINGS: Identified interventions are presented according to a framework for behaviour change, MINDSPACE. Articles (n=48) from 10 primarily high-income countries were included in the review. Nudging-based interventions identified include using reminders and recall, changing the way information is framed and delivered to an intended audience, changing the messenger delivering information, invoking social norms and emotional affect (eg, through storytelling, dramatic narratives and graphical presentations), and offering incentives or changing defaults. The most promising evidence exists for nudges that offer incentives to parents and healthcare workers, that make information more salient or that use trusted messengers to deliver information. The effectiveness of nudging interventions and the direction of the effect varies substantially by context. Evidence for some approaches is mixed, highlighting a need for further research, including how successful interventions can be adapted across settings. CONCLUSION: Nudging-based interventions show potential to increase vaccine confidence and uptake, but further evidence is needed for the development of clear recommendations. The ongoing COVID-19 pandemic increases the urgency of undertaking nudging-focused research. PROSPERO REGISTRATION NUMBER: CRD42020185817.

Evaluation of a community-based mobile video breastfeeding intervention in Khayelitsha, South Africa: The Philani MOVIE cluster-randomized controlled trial.

BACKGROUND: In South Africa, breastfeeding promotion is a national health priority. Regular perinatal home visits by community health workers (CHWs) have helped promote exclusive breastfeeding (EBF) in underresourced settings. Innovative, digital approaches including mobile video content have also shown promise, especially as access to mobile technology increases among CHWs. We measured the effects of an animated, mobile video series, the Philani MObile Video Intervention for Exclusive breastfeeding (MOVIE), delivered by a cadre of CHWs ("mentor mothers"). METHODS AND FINDINGS: We conducted a stratified, cluster-randomized controlled trial from November 2018 to March 2020 in Khayelitsha, South Africa. The trial was conducted in collaboration with the Philani Maternal Child Health and Nutrition Trust, a nongovernmental community health organization. We quantified the effect of the MOVIE intervention on EBF at 1 and 5 months (primary outcomes), and on other infant feeding practices and maternal knowledge (secondary outcomes). We randomized 1,502 pregnant women in 84 clusters 1:1 to 2 study arms. Participants' median age was 26 years, 36.9% had completed secondary school, and 18.3% were employed. Mentor mothers in the video intervention arm provided standard-of-care counseling plus the MOVIE intervention; mentor mothers in the control arm provided standard of care only. Within the causal impact evaluation, we nested a mixed-methods performance evaluation measuring mentor mothers' time use and eliciting their subjective experiences through in-depth interviews. At both points of follow-up, we observed no statistically significant differences between the video intervention and the control arm with regard to EBF rates and other infant feeding practices [EBF in the last 24 hours at 1 month: RR 0.93 (95% CI 0.86 to 1.01, P = 0.091); EBF in the last 24 hours at 5 months: RR 0.90 (95% CI 0.77 to 1.04, P = 0.152)]. We observed a small, but significant improvement in maternal knowledge at the 1-month follow-up, but not at the 5-month follow-up. The interpretation of the results from this causal impact evaluation changes when we consider the results of the nested mixed-methods performance evaluation. The mean time spent per home visit was similar across study arms, but the intervention group spent approximately 40% of their visit time viewing videos. The absence of difference in effects on primary and secondary endpoints implies that, for the same time investment, the video intervention was as effective as face-to-face counseling with a mentor mother. The videos were also highly valued by mentor mothers and participants. Study limitations include a high loss to follow-up at 5 months after premature termination of the trial due to the COVID-19 pandemic and changes in mentor mother service demarcations. CONCLUSIONS: This trial measured the effect of a video-based, mobile health (mHealth) intervention, delivered by CHWs during home visits in an underresourced setting. The videos replaced about two-fifths of CHWs' direct engagement time with participants in the intervention arm. The similar outcomes in the 2 study arms thus suggest that the videos were as effective as face-to-face counselling, when CHWs used them to replace a portion of that counselling. Where CHWs are scarce, mHealth video interventions could be a feasible and practical solution, supporting the delivery and scaling of community health promotion services. TRIAL REGISTRATION: The study and its outcomes were registered at clinicaltrials.gov (#NCT03688217) on September 27, 2018.

Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): study protocol for a two-factorial randomized controlled multi-arm trial with cluster sampling.

BACKGROUND: To achieve higher effectiveness in population-based SARS-CoV-2 surveillance and to reliably predict the course of an outbreak, screening, and monitoring of infected individuals without major symptoms (about 40% of the population) will be necessary. While current testing capacities are also used to identify such asymptomatic cases, this rather passive approach is not suitable in generating reliable population-based estimates of the prevalence of asymptomatic carriers to allow any dependable predictions on the course of the pandemic. METHODS: This trial implements a two-factorial, randomized, controlled, multi-arm, prospective, interventional, single-blinded design with cluster sampling and four study arms, each representing a different SARS-CoV-2 testing and surveillance strategy based on individuals' self-collection of saliva samples which are then sent to and analyzed by a laboratory. The targeted sample size for the trial is 10,000 saliva samples equally allocated to the four study arms (2500 participants per arm). Strategies differ with respect to tested population groups (individuals vs. all household members) and testing approach (without vs. with pre-screening survey). The trial is complemented by an economic evaluation and qualitative assessment of user experiences. Primary outcomes include costs per completely screened person, costs per positive case, positive detection rate, and precision of positive detection rate. DISCUSSION: Systems for active surveillance of the general population will gain more importance in the context of pandemics and related disease prevention efforts. The pandemic parameters derived from such active surveillance with routine population monitoring therefore not only enable a prospective assessment of the short-term course of a pandemic, but also a more targeted and thus more effective use of local and short-term countermeasures. TRIAL REGISTRATION: ClinicalTrials.gov DRKS00023271 . Registered November 30, 2020, with the German Clinical Trials Register (Deutsches Register Klinischer Studien).

Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): a structured summary of a study protocol for a cluster-randomised, two-factorial controlled trial.

OBJECTIVES: In this cluster-randomised controlled study (CoV-Surv Study), four different "active" SARS-CoV-2 testing strategies for general population surveillance are evaluated for their effectiveness in determining and predicting the prevalence of SARS-CoV-2 infections in a given population. In addition, the costs and cost-effectiveness of the four surveillance strategies will be assessed. Further, this trial is supplemented by a qualitative component to determine the acceptability of each strategy. Findings will inform the choice of the most effective, acceptable and affordable strategy for SARS-CoV-2 surveillance, with the most effective and cost-effective strategy becoming part of the local public health department's current routine health surveillance activities. Investigating its everyday performance will allow us to examine the strategy's applicability to real time prevalence prediction and the usefulness of the resulting information for local policy makers to implement countermeasures that effectively prevent future nationwide lockdowns. The authors would like to emphasize the importance and relevance of this study and its expected findings in the context of population-based disease surveillance, especially in respect to the current SARS-CoV-2 pandemic. In Germany, but also in many other countries, COVID-19 surveillance has so far largely relied on passive surveillance strategies that identify individuals with clinical symptoms, monitor those cases who then tested positive for the virus, followed by tracing of individuals in close contact to those positive cases. To achieve higher effectiveness in population surveillance and to reliably predict the course of an outbreak, screening and monitoring of infected individuals without major symptoms (about 40% of the population) will be necessary. While current testing capacities are also used to identify such asymptomatic cases, this rather passive approach is not suitable in generating reliable population-based estimates of the prevalence of asymptomatic carriers to allow any dependable predictions on the course of the pandemic. To better control and manage the SARS-CoV-2 pandemic, current strategies therefore need to be complemented by an active surveillance of the wider population, i.e. routinely conducted testing and monitoring activities to identify and isolate infected individuals regardless of their clinical symptoms. Such active surveillance strategies will enable more effective prevention of the spread of the virus as they can generate more precise population-based parameters during a pandemic. This essential information will be required in order to determine the best strategic and targeted short-term countermeasures to limit infection spread locally. TRIAL DESIGN: This trial implements a cluster-randomised, two-factorial controlled, prospective, interventional, single-blinded design with four study arms, each representing a different SARS-CoV-2 testing and surveillance strategy. PARTICIPANTS: Eligible are individuals age 7 years or older living in Germany's Rhein-Neckar Region who consent to provide a saliva sample (all four arms) after completion of a brief questionnaire (two arms only). For the qualitative component, different samples of study participants and non-participants (i.e. eligible for study, but refuse to participate) will be identified for additional interviews. For these interviews, only individuals age 18 years or older are eligible. INTERVENTION AND COMPARATOR: Of the four surveillance strategies to be assessed and compared, Strategy A1 is considered the gold standard for prevalence estimation and used to determine bias in other arms. To determine the cost-effectiveness, each strategy is compared to status quo, defined as the currently practiced passive surveillance approach. Strategy A1: Individuals (one per household) receive information and study material by mail with instructions on how to produce a saliva sample and how to return the sample by mail. Once received by the laboratory, the sample is tested for SARS-CoV-2 using Reverse Transcription Loop-mediated Isothermal Amplification (RT-LAMP). Strategy A2: Individuals (one per household) receive information and study material by mail with instructions on how to produce their own as well as saliva samples from each household member and how to return these samples by mail. Once received by the laboratory, the samples are tested for SARS-CoV-2 using RT-LAMP. Strategy B1: Individuals (one per household) receive information by mail on how to complete a brief pre-screening questionnaire which asks about COVID-19 related clinical symptoms and risk exposures. Only individuals whose pre-screening score crosses a defined threshold, will then receive additional study material by mail with instructions on how to produce a saliva sample and how to return the sample by mail. Once received by the laboratory, the saliva sample is tested for SARS-CoV-2 using RT-LAMP. Strategy B2: Individuals (one per household) receive information by mail on how to complete a brief pre-screening questionnaire which asks about COVID-19 related clinical symptoms. Only individuals whose pre-screening score crosses a defined threshold, will then receive additional study material by mail with instructions how to produce their own as well as saliva samples from each household member and how to return these samples by mail. Once received by the laboratory, the samples are tested for SARS-CoV-2 using RT-LAMP. In each strategy, RT-LAMP positive samples are additionally analyzed with qPCR in order to minimize the number of false positives. MAIN OUTCOMES: The identification of the one best strategy will be determined by a set of parameters. Primary outcomes include costs per correctly screened person, costs per positive case, positive detection rate, and precision of positive detection rate. Secondary outcomes include participation rate, costs per asymptomatic case, prevalence estimates, number of asymptomatic cases per study arm, ratio of symptomatic to asymptomatic cases per study arm, participant satisfaction. Additional study components (not part of the trial) include cost effectiveness of each of the four surveillance strategies compared to passive monitoring (i.e. status quo), development of a prognostic model to predict hospital utilization caused by SARS-CoV-2, time from test shipment to test application and time from test shipment to test result, and perception and preferences of the persons to be tested with regard to test strategies. RANDOMISATION: Samples are drawn in three batches of three continuous weeks. Randomisation follows a two-stage process. First, a total of 220 sampling points have been allocated to the three different batches. To obtain an integer solution, the Cox-algorithm for controlled rounding has been used. Afterwards, sample points have been drawn separately per batch, following a probability proportional to size (PPS) random sample. Second, for each cluster the same number of residential addresses is randomly sampled from the municipal registries (self-weighted sample of individuals). The 28,125 addresses drawn per municipality are then randomly allocated to the four study arms A1, A2, B1, and B2 in the ratio 5 to 2.5 to 14 to 7 based on the expected response rates in each arm and the sensitivity and specificity of the pre-screening tool as applied in strategy B1 and B2. Based on the assumptions, this allocation should yield 2500 saliva samples in each strategy. Although a municipality can be sampled by multiple batches and the overall number of addresses per municipality might vary, the number of addresses contacted in each arm is kept constant. BLINDING (MASKING): The design is single-blinded, meaning the staff conducting the SARS-CoV-2 tests are unaware of the study arm assignment of each single participant and test sample. SAMPLE SIZES: Total sample size for the trial is 10,000 saliva samples equally allocated to the four study arms (i.e. 2,500 participants per arm). For the qualitative component, up to 60 in-depth interviews will be conducted with about 30 study participants (up to 15 in each arm A and B) and 30 participation refusers (up to 15 in each arm A and B) purposefully selected from the quantitative study sample to represent a variety of gender and ages to explore experiences with admission or rejection of study participation. Up to 25 asymptomatic SARS-CoV-2 positive study participants will be purposefully selected to explore the way in which asymptomatic men and women diagnosed with SARS-CoV-2 give meaning to their diagnosis and to the dialectic between feeling concurrently healthy and yet also being at risk for transmitting COVID-19. In addition, 100 randomly selected study participants will be included to explore participants' perspective on testing processes and implementation. TRIAL STATUS: Final protocol version is "Surveillance_Studienprotokoll_03Nov2020_v1_2" from November 3, 2020. Recruitment started November 18, 2020 and is expected to end by or before December 31, 2020. TRIAL REGISTRATION: The trial is currently being registered with the German Clinical Trials Register (Deutsches Register Klinischer Studien), DRKS00023271 ( https://www.drks.de/drks_web/navigate.do?navigationId=trial . HTML&TRIAL_ID=DRKS00023271). Retrospectively registered 30 November 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Scared, powerless, insulted and embarrassed: hesitancy towards vaccines among caregivers in Cavite Province, the Philippines.

BACKGROUND: Several studies have highlighted that vaccine hesitancy (VH) is among the most important threats to global health, especially in low- and middle-income countries, including the Philippines. However, there is a dearth of literature exploring family experiences of-or concerns related to-childhood vaccinations that gives voice to vaccine hesitant caregivers (VHCs) of small children. Here, we present insights from VHCs from the Philippines. METHODS: This research draws on in-depth interviews (IDIs) with 44 VHCs who had previously delayed or refused vaccination for their children in rural and urban communities in Cavite Province, the Philippines. Amid the COVID-19 pandemic, we conducted IDIs via an online platform of the respondents' choosing (ie, Facebook messenger call, Skype and Zoom). All interviews were recorded, transcribed, translated and analysed drawing from the tenets of constructivist grounded theory. We use the social ecological model to structure our results. RESULTS: Among the reasons for delay or refusal of childhood vaccinations, a fear of side effects emerged as the most salient concern, exacerbated by previous negative experiences (including trauma) from a dengue vaccine controversy in 2017. Respondents cited the dengue vaccine controversy as they expressed reluctance (regarding any new vaccines) and suspicion (towards school-based vaccination, the distribution channel used for the dengue vaccine). Heads of households opposing vaccines, perceptions that vaccines are non-essential and influences from the social and traditional media or neighbours contributed to further refusal and delay. Upon probing, VHCs recounted health system concerns particularly with regards to healthcare workers who are sometimes unable to answer their questions and can be dismissive or disrespectful regarding caregivers' concerns. CONCLUSION: Understanding VH from the lens of VHCs highlights pathways for interventions to regain trust and bolster confidence towards vaccines. Our findings may serve as linchpins in the development of VH interventions aiming at changing behaviour on a population scale.