Daily use of lateral flow devices by contacts of confirmed COVID-19 cases to enable exemption from isolation compared with standard self-isolation to reduce onward transmission of SARS-CoV-2 in England: a randomised, controlled, non-inferiority trial.

BACKGROUND: In the UK, during the study period (April to July, 2021), all contacts of people with COVID-19 were required to self-isolate for 10 days, which had adverse impacts on individuals and society. Avoiding the need to self-isolate for those who remain uninfected would be beneficial. We investigated whether daily use of lateral flow devices (LFDs) to test for SARS-CoV-2, with removal of self-isolation for 24 h if negative, could be a safe alternative to self-isolation as a means to minimise onward transmission of the virus. METHODS: We conducted a randomised, controlled, non-inferiority trial in adult contacts identified by COVID-19 contact tracing in England. Consenting participants were randomly assigned to self-isolation (single PCR test, 10-day isolation) or daily contact testing (DCT; seven LFD tests, two PCR tests, no isolation if negative on LFD); participants from a single household were assigned to the same group. Participants were prospectively followed up, with the effect of each intervention on onward transmission established from routinely collected NHS Test and Trace contact tracing data for participants who tested PCR-positive for SARS-CoV-2 during the study period and tertiary cases arising from their contacts (ie, secondary contacts). The primary outcome of the study was the attack rate, the percentage of secondary contacts (close contacts of SARS-CoV-2-positive study participants) who became COVID-19 cases (tertiary cases) in each group. Attack rates were derived from Bernoulli regression models using Huber-White (robust) sandwich estimator clustered standard errors. Attack rates were adjusted for household exposure, vaccination status, and ability to work from home. The non-inferiority margin was 1·9%. The primary analysis was a modified intention-to-treat analysis excluding those who actively withdrew from the study as data from these participants were no longer held. This study is registered with the Research Registry (number 6809). Data collection is complete; analysis is ongoing. FINDINGS: Between April 29 and July 28, 2021, 54 923 eligible individuals were enrolled in the study, with final group allocations (following withdrawals) of 26 123 (52·6%) participants in the DCT group and 23 500 (47·4%) in the self-isolation group. Overall, 4694 participants tested positive for SARS-CoV-2 by PCR (secondary cases), 2364 (10·1%) in the self-isolation group and 2330 (8·9%) in the DCT group. Adjusted attack rates (among secondary contacts) were 7·5% in the self-isolation group and 6·3% in the DCT group (difference of -1·2% [95% CI -2·3 to -0·2]; significantly lower than the non-inferiority margin of 1·9%). INTERPRETATION: DCT with 24 h exemption from self-isolation for essential activities appears to be non-inferior to self-isolation. This study, which provided evidence for the UK Government's daily lateral flow testing policy for vaccinated contacts of COVID-19 cases, indicated that daily testing with LFDs could allow individuals to reduce the risk of onward transmission while minimising the adverse effects of self-isolation. Although contacts in England are no longer required to isolate, the findings will be relevant for future policy decisions around COVID-19 or other communicable infections. FUNDING: UK Government Department of Health and Social Care.

Exploring the impact of shielding advice on the wellbeing of individuals identified as clinically extremely vulnerable amid the COVID-19 pandemic: a mixed-methods evaluation.

BACKGROUND: The national shielding programme was introduced by UK Government at the beginning of the COVID-19 pandemic, with individuals identified as clinically extremely vulnerable (CEV) offered advice and support to stay at home and avoid all non-essential contact. This study aimed to explore the impact and responses of "shielding" on the health and wellbeing of CEV individuals in Southwest England during the first COVID-19 lockdown. METHODS: A two-stage mixed methods study, including a structured survey (7 August-23 October 2020) and semi-structured telephone interviews (26 August-30 September 2020) with a sample of individuals who had been identified as CEV and advised to "shield" by Bristol, North Somerset & South Gloucestershire (BNSSG) Clinical Commissioning Group (CCG). RESULTS: The survey was completed by 203 people (57% female, 54% > 69 years, 94% White British, 64% retired) in Southwest England identified as CEV by BNSSG CCG. Thirteen survey respondents participated in follow-up interviews (53% female, 40% > 69 years, 100% White British, 61% retired). Receipt of 'official' communication from NHS England or General Practitioner (GP) was considered by participants as the legitimate start of shielding. 80% of survey responders felt they received all relevant advice needed to shield, yet interviewees criticised the timing of advice and often sought supplementary information. Shielding behaviours were nuanced, adapted to suit personal circumstances, and waned over time. Few interviewees received community support, although food boxes and informal social support were obtained by some. Worrying about COVID-19 was common for survey responders (90%). Since shielding had begun, physical and mental health reportedly worsened for 35% and 42% of survey responders respectively. 21% of survey responders scored ≥ 10 on the PHQ-9 questionnaire indicating possible depression and 15% scored ≥ 10 on the GAD-7 questionnaire indicating possible anxiety. CONCLUSIONS: This research highlights the difficulties in providing generic messaging that is applicable and appropriate given the diversity of individuals identified as CEV and the importance of sharing tailored and timely advice to inform shielding decisions. Providing messages that reinforce self-determined action and assistance from support services could reduce the negative impact of shielding on mental health and feelings of social isolation.

A mixed methods analysis of participation in a social contact survey.

BACKGROUND: Social contact survey data forms a core component of modern epidemic models: however, there has been little assessment of the potential biases in such data. METHODS: We conducted focus groups with university students who had (n = 13) and had never (n = 14) completed a social contact survey during the COVID-19 pandemic. Qualitative findings were explored quantitatively by analysing participation data. RESULTS: The opportunity to contribute to COVID-19 research, to be heard and feel useful were frequently reported motivators for participating in the contact survey. Reductions in survey engagement following lifting of COVID-19 restrictions may have occurred because the research was perceived to be less critical and/or because the participants were busier and had more contacts. Having a high number of contacts to report, uncertainty around how to report each contact, and concerns around confidentiality were identified as factors leading to inaccurate reporting. Focus groups participants thought that financial incentives or provision of study results would encourage participation. CONCLUSIONS: Incentives could improve engagement with social contact surveys. Qualitative research can inform the format, timing, and wording of surveys to optimise completion and accuracy.

A qualitative process analysis of daily contact testing as an alternative to self-isolation following close contact with a confirmed carrier of SARS-CoV-2.

BACKGROUND: In July 2021, a randomised controlled trial was conducted to compare the effect on SARS-CoV-2 transmission of seven days of Daily Contact Testing (DCT) using Lateral Flow Test (LFT) and two Polymerase Chain Reaction (PCR) tests as an alternative to 10 days of standard self-isolation with one PCR, following close contact with a SARS-CoV-2 carrier. In this qualitative study, we used a nested process evaluation to aid interpretation of the trial and provide insight into factors influencing use of tests, understanding of test results, and how tests were used to inform behavioural decisions. METHODS: Interviews were conducted with 60 participants (42 randomised to DCT and 18 randomised to self-isolation) who had been in close contact with a confirmed SARS-CoV-2 carrier and had consented to take part in the trial. RESULTS: Data were organised into three overarching themes: (1) assessing the risks and benefits of DCT (2) use of testing during the study period and (3) future use of testing. Attitudes toward DCT as an alternative to self-isolation and behaviour during the testing period appeared to be informed by an assessment of the associated risks and benefits. Participants reported how important it was for them to avoid isolation, how necessary self-isolation was considered to be, and the ability of LFTs to detect infection. Behaviour during the testing period was modified to reduce risks and harms as much as possible. Testing was considered a potential compromise, reducing both risk of transmission and the negative impact of self-isolation, and was regarded as a way to return to normal. CONCLUSION: Participants in this study viewed DCT as a sensible, feasible, and welcome means of avoiding unnecessary self-isolation. Although negative LFTs provided reassurance, most people still restricted their activity as recommended. DCT was also highly valued by those in vulnerable households as a means of providing reassurance of the absence of infection and as an important means of detecting infection and prompting self-isolation when necessary.

The Rapid Adaptation and Optimisation of a Digital Behaviour-Change Intervention to Reduce the Spread of COVID-19 in Schools.

The rapid transmission of COVID-19 in school communities has been a major concern. To ensure that mitigation systems were in place and support was available, a digital intervention to encourage and facilitate infection-control behaviours was rapidly adapted and optimised for implementation as a whole-school intervention. Using the person-based approach, 'Germ Defence' was iteratively adapted, guided by relevant literature, co-production with Patient and Public Involvement representatives, and think-aloud interviews with forty-five school students, staff, and parents. Suggested infection-control behaviours deemed feasible and acceptable by the majority of participants included handwashing/hand-sanitising and wearing a face covering in certain contexts, such as crowded public spaces. Promoting a sense of collective responsibility was reported to increase motivation for the adoption of these behaviours. However, acceptability and willingness to implement recommended behaviours seemed to be influenced by participants' perceptions of risk. Barriers to the implementation of recommended behaviours in school and at home primarily related to childcare needs and physical space. We conclude that it was possible to rapidly adapt Germ Defence to provide an acceptable resource to help mitigate against infection transmission within and from school settings. Adapted content was considered acceptable, persuasive, and accessible.

Exploration of attitudes regarding uptake of COVID-19 vaccines among vaccine hesitant adults in the UK: a qualitative analysis.

BACKGROUND: The aim of this work was to explore barriers and facilitators to uptake of COVID-19 vaccines and to explore views and reactions to efforts to improve vaccine uptake among vaccine hesitant individuals. METHODS: Semi-structured interviews were conducted with people between the age of 18-29 years who had not had a COVID-19 vaccine, and those between 30 and 49 years who had not had a second dose of a COVID-19 vaccine. RESULTS: A total of 70 participants took part in the study, 35 participants had received one dose, and 35 had not been vaccinated. Participants described a willingness to be vaccinated to keep themselves and those around them safe and to avoid restrictions. Barriers to uptake included: (1) perceived lack of need for COVID-19 vaccinations, (2) concerns about the efficacy of vaccinations, (3) concerns about safety, and (4) access issues. Uptake appeared to be influenced by age and health status, trust in government, and knowledge and understanding of science. Introduction of vaccine passes may provide a motive for having a vaccine but may be viewed as coercive. CONCLUSION: Participants were hesitant, rather than opposed, and had questions about their need for, and the safety and efficacy of the vaccine. Young people did not consider themselves to be at risk of becoming ill from COVID-19, did not think the vaccination was effective in preventing transmission, and did not think sufficient research had been conducted regarding possible long-term side-effects. Concerns were exacerbated by a lack of trust in government, and misunderstanding of science. To promote uptake, public health campaigns should focus on the provision of information from trusted sources that explains the benefits of vaccination and addresses safety concerns more effectively. To overcome inertia in people with low levels of motivation to be vaccinated, appointments must be easily accessible.

Feasibility and acceptability of daily testing at school as an alternative to self-isolation following close contact with a confirmed case of COVID-19: a qualitative analysis.

BACKGROUND: Daily testing using a rapid Lateral Flow Device (LFD) has been suggested as an alternative to self-isolation. A randomised trial comparing daily contact testing (DCT) in schools with self-isolation found that SARS-CoV-2 transmission within school was comparable and low in both groups. However, if this approach is to be adopted widely, it is critical that we understand the perspective of those who will be delivering and receiving DCT. The aim of this qualitative process study embedded in the randomised controlled trial (RCT) was to improve understanding of a range of behavioural factors that could influence implementation. METHODS: Interviews were conducted with 63 participants, including staff, students, and parents of students who had been identified as being in close contact with someone with COVID-19. The topic guide explored perceptions of daily testing, understanding of positive and negative test results, and adherence to guidance. Data were analysed using an inductive thematic approach. RESULTS: Results were organised under three main headings: (1) factors influencing daily testing (2) interpretation of test results (3) behaviour during testing period. Participants recognized that daily testing may allow students to remain in school, which was viewed as necessary for both education and social needs. Whilst some felt safer as a result of daily testing, others raised concerns about safety. Participants did not always understand how to interpret and respond to test results, and although participants reported high levels of adherence to the guidance, improved communications were desired. CONCLUSION: Daily testing may be a feasible and acceptable alternative to self-isolation among close contacts of people who test positive. However, improved communications are needed to ensure that all students and parents have a good understanding of the rationale for testing, what test results mean, how test results should be acted on, and how likely students are to test positive following close contact. Support is needed for students and parents of students who have to self-isolate and for those who have concerns about the safety of daily testing.

Development of a multicomponent intervention to increase parental vaccine confidence and young people's access to the universal HPV vaccination programme in England: protocol for a co-design study.

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.

Preventing within household transmission of Covid-19: is the provision of accommodation to support self-isolation feasible and acceptable?

BACKGROUND: Within-household transmission of Covid-19 is responsible for a significant number of infections. Efforts to protect at risk communities are needed. This study explored the acceptability of offering accommodation to support self-isolation among at risk populations, to prevent transmission of Covid-19 within vulnerable households. METHODS: Mixed methods design structured in two phases. Phase 1: Survey of 545 individuals who had provided consent to be contacted about ongoing research projects into infection control. Phase 2: Semi-structured interviews with 19 participants from ethnic minority and low income communities. RESULTS: Many survey and interview participants viewed the provision of accommodation as important and necessary in certain contexts. Of the 110 survey respondents, 85 (77%) said that they were not able to isolate at home. Among this group, 24 (28%) said they would accept accommodation and 23 (27%) said that they would probably accept. Of those unable to isolate at home, and at high risk if they caught the virus (N = 36) or living with someone at high risk (N 18), 19 (35%) said that they would accept, and 12 (22%) said they would probably accept accommodation. Factors influencing uptake of accommodation included perceived 1) household vulnerability 2) virus exposure and 3) lack of isolation at home options. Barriers to accepting the accommodation offer included 1) able to isolate at home 2) wanting to be with family 3) caring responsibilities 4) mental wellbeing concerns 5) concerns about moving when ill and 6) infection control concerns. Participants raised issues that should be addressed before accommodation is offered, including questions regarding who should use temporary accommodation and when, and how infection control in temporary accommodation would be managed. CONCLUSION: The provision of accommodation to prevent within household transmission of Covid-19 is viewed as acceptable, feasible and necessary by some people who are concerned about infection transmission in the home and are unable to self-isolate or socially distance at home. Different households will have different requirements, e.g., those with caring responsibilities, and to overcome these challenges additional support may be needed for the provision of accommodation to be feasible to those who could benefit most.

Engagement With Daily Testing Instead of Self-Isolating in Contacts of Confirmed Cases of SARS-CoV-2: A Qualitative Analysis.

Introduction: In December 2020 and January 2021 Public Health England (PHE) with NHS Test and Trace conducted a study to explore the feasibility and acceptability of daily testing as an alternative to self-isolation following close contact with a confirmed COVID-19 case. This qualitative paper aims to identify factors influencing uptake among those offered daily testing, and the subsequent impact on behaviour. Methods: We conducted in-depth interviews with 52 participants who had taken part in the feasibility study. Participants were asked about their experiences of daily testing or self-isolating, their reasons for choosing to test or isolate, and their behaviour during the study period. Data were analysed using inductive thematic analysis. Results: Results are presented under two main headings: (1) factors influencing acceptance of testing and (2) impact of test results. Participants appeared highly motivated to engage in behaviours that would protect others from the virus. Factors influencing the decision to accept testing included (1) needing to avoid self-isolation, (2) concerns about test sensitivity, and (3) perceived benefits of detecting infection. Participants who were taking tests reported: (1) positive consequences following confirmation of COVID status, (2) engaging in essential activities, (3) uncertainty, and (4) self-isolating whilst testing. Conclusions: This study has identified a range of factors that appear to influence the decision to engage in daily testing or to self-isolate following close contact with a positive case, many of which could be addressed by clear communications. Covid-19 infection rates and government restrictions influenced experiences, and so further research is needed to explore perceptions of daily testing and behaviour following close contact with a positive case among a wider range of individuals, in the context of lower rates of COVID-19, few government restrictions on general population behaviour and more widespread testing.

Effectiveness of digital interventions to improve household and community infection prevention and control behaviours and to reduce incidence of respiratory and/or gastro-intestinal infections: a rapid systematic review.

BACKGROUND: Digital interventions have potential to efficiently support improved hygiene practices to reduce transmission of COVID-19. OBJECTIVE: To evaluate the evidence for digital interventions to improve hygiene practices within the community. METHODS: We reviewed articles published between 01 January 2000 and 26 May 2019 that presented a controlled trial of a digital intervention to improve hygiene behaviours in the community. We searched MEDLINE, Embase, PsycINFO, Cochrane Controlled Register of Trials (CENTRAL), China National Knowledge Infrastructure and grey literature. Trials in hospitals were excluded, as were trials aiming at prevention of sexually transmitted infections; only target diseases with transmission mechanisms similar to COVID-19 (e.g. respiratory and gastrointestinal infections) were included. Trials had to evaluate a uniquely digital component of an intervention. Study designs were limited to randomised controlled trials, controlled before-and-after trials, and interrupted time series analyses. Outcomes could be either incidence of infections or change in hygiene behaviours. The Risk of Bias 2 tool was used to assess study quality. RESULTS: We found seven studies that met the inclusion criteria. Six studies reported successfully improving self-reported hygiene behaviour or health outcomes, but only one of these six trials, Germ Defence, confirmed improvements using objective measures (reduced consultations and antibiotic prescriptions). Settings included kindergartens, workplaces, and service station restrooms. Modes of delivery were diverse: WeChat, website, text messages, audio messages to mobiles, electronic billboards, and electronic personal care records. Four interventions targeted parents of young children with educational materials. Two targeted the general population; these also used behaviour change techniques or theory to inform the intervention. Only one trial had low risk of bias, Germ Defence; the most common concerns were lack of information about the randomisation, possible bias in reporting of behavioural outcomes, and lack of an analysis plan and possible selective reporting of results. CONCLUSION: There was only one trial that was judged to be at low risk of bias, Germ Defence, which reduced incidence and severity of illness, as confirmed by objective measures. Further evaluation is required to determine the effectiveness of the other interventions reviewed. TRIAL REGISTRATION: PROSPERO CRD42020189919 .

Engagement with daily testing instead of self-isolating in contacts of confirmed cases of SARS-CoV-2.

BACKGROUND: In December 2020, Public Health England with NHS Test and Trace initiated a pilot study in which close contacts of people with confirmed COVID-19 were given the option to carryout lateral flow device antigen tests at home, as an alternative to self-isolation for 10-14 days. In this study, we evaluated engagement with daily testing, and assessed levels of adherence to the rules relating to behaviour following positive or negative test results. METHODS: We conducted a service evaluation of the pilot study, examining survey responses from a subset of those who responded to an evaluation questionnaire. We used an online cross-sectional survey offered to adult contacts of confirmed COVID-19 cases who consented to daily testing. We used a comparison group of contacts who were not offered testing and instead self-isolated. RESULTS: Acceptability of daily testing was lower among survey respondents who were not offered the option of testing and among people from ethnic minority groups. Overall, 52% of respondents reported being more likely to share details of people that they had been in contact with following a positive test result, if they knew that their contacts would be offered the option of daily testing. Only 2% reported that they would be less likely to provide details of their contacts. On the days that they were trying to self-isolate, 19% of participants reported that they left the house, with no significant group differences. Following a negative test, 13% of respondents reported that they increased their contacts, but most (58%) reported having fewer risky contacts. CONCLUSIONS: Our data suggest that daily testing is potentially acceptable, may facilitate sharing contact details of close contacts among those who test positive for COVID-19, and promote adherence to self-isolation. A better understanding is needed of how to make this option more acceptable for all households. The impact of receiving a negative test on behaviour remains a risk that needs to be monitored and mitigated by appropriate messaging. Future research should examine attitudes and behaviour in a context where infection levels are lower, testing is more familiar, and restrictions on activity have been reduced.

Understanding patterns of adherence to COVID-19 mitigation measures: a qualitative interview study.

BACKGROUND: Evidence highlights the disproportionate impact of measures that have been introduced to reduce the spread of coronavirus on individuals from Black, Asian and minority ethnic (BAME) communities, and among those on a low income. An understanding of barriers to adherence in these populations is needed. In this qualitative study, we examined the patterns of adherence to mitigation measures and reasons underpinning these behaviors. METHODS: Semi-structured interviews were conducted with 20 participants from BAME and low-income White backgrounds. The topic guide was designed to explore how individuals are adhering to social distancing and self-isolation during the pandemic and to explore the reasons underpinning this behavior. RESULTS: We identified three categories of adherence to lockdown measures: (i) caution-motivated super-adherence (ii) risk-adapted partial-adherence and (iii) necessity-driven partial-adherence. Decisions about adherence considered potential for exposure to the virus, ability to reduce risk through use of protective measures and perceived importance of/need for the behavior. CONCLUSIONS: This research highlights a need for a more nuanced understanding of adherence to lockdown measures. Provision of practical and financial support could reduce the number of people who have to engage in necessity-driven partial-adherence. More evidence is required on population level risks of people adopting risk-adapted partial-adherence.