ACCESS TO AND EXPERIENCES OF REMOTE HIV CLINICAL SERVICES IN HIGH-INCOME SETTINGS: A SCOPING REVIEW

Background Remote delivery of HIV services (often facilitated by digital technology) has increased over recent years, especially in response to the COVID-19 pandemic. Using scoping methods, we synthesise current knowledge about remote HIV healthcare services. Methods We systematically searched literature using multiple databases, supplementing this with searches of grey literature. We included papers reporting on empirical studies in high income countries (OECD) of remote HIV healthcare delivery by digital technology including mobile apps, video, SMS and telephone. We extracted data using a standardised tool and analysed data thematically. Results A large proportion of studies focus on interventions supporting antiretroviral therapy adherence, often via mobile apps or SMS. There has been a recent uptick in work describing remote routine HIV clinical appointments in the context of COVID-19. There was a dearth of evidence on the impact of remote HIV healthcare services on clinical and patientreported outcomes, as well as factors shaping access to remote HIV healthcare services. Discussion There is an increasingly large body of work investigating remote HIV healthcare services, much of it focusing on adherence support. Less is known on barriers to and facilitators of remote HIV healthcare service provision and access, and how these services impact patient experience and outcomes. Given the enduring change to models of HIV healthcare as a result of COVID-19, we urgently require a robust evidence-base to inform inclusive, equitable and effective service design.

HOW DID THE COVID-19 PANDEMIC AFFECT UNMET NEED FOR CONDOMS AT A POPULATION LEVEL? (NATSAL-COVID)

Introduction Use of condoms to prevent STIs/HIV and unplanned pregnancy remains important during the COVID-19 pandemic. However, it is unknown whether the pandemic affected condom access and which population groups were most impacted. Methods 6658 participants (18-59y) completed a cross-sectional web survey one-year after the initial British lockdown from 23 March 2020. Quota-based sampling and weighting resulted in a sample that was quasi-representative of the British population. We report the prevalence of unmet need for condoms because of the pandemic among sexually-experienced participants aged 18-44 years (n=2869). Adjusted odds ratios (AOR) quantify associations with demographic and behavioural factors. Results Overall, 6.9% of women and 16.2% of men reported unmet need for condoms in the past year because of the pandemic. This was more likely to be reported by participants who: were aged 18-24 years vs. 35-44 (AOR: men 2.25 [95% CI:1.26-4.01], women 2.95[1.42-6.16]);were Black or Black British vs. White (men 2.86 [1.45-5.66], women 1.93 [1.03- 8.30]);reported same-sex sex vs. not (past five years;men 2.85 [1.68-4.86], women 5.00 [2.48-10.08]);or ≥1 new relationships vs. not (past year, men 5.85 [3.55-9.66], women 6.38 [3.24-12.59]). Men, but not women, reporting STIrelated service use (past year) were more likely to report unmet need for condoms compared to men that did not report service use (3.83 [2.18-6.71]). Discussion Unmet need for condoms because of the pandemic was more likely to be reported by populations at higher risk of adverse sexual health outcomes, including STI/HIV transmission. Improved access to free/low-cost condoms is crucial for all.

INEQUALITIES IN REPRODUCTIVE HEALTH OUTCOMES DURING COVID-19 IN BRITAIN: NATIONAL SURVEY (NATSAL COVID)

Introduction The COVID-19 pandemic presented challenges to delivery of reproductive health services. To explore effects, we examined patterns of contraceptive use, service access and pregnancy planning in the year following the first UK lockdown. Methods The Natsal-COVID Wave 2 survey was conducted in March-April 2021, one year after the first lockdown began in Britain. We analysed a subset of sexually-active participants aged 18-44 years and described as female at birth. We estimated differences in outcomes by age and markers of vulnerability. We examined changing contraception use, access to and unmet need for contraceptive services, and London Measure of Unplanned Pregnancy scores (LMUP;range 0-12). Results Of 1,488 eligible participants, 78.0% were considered at risk of unplanned pregnancies. Of 441 at-risk participants who tried to access contraceptive services, 16.4% faced barriers. Young participants (18-24 years) were most likely to report trying to access contraceptive services (38.4%;(32.2, 45.0);vs 28.4% overall) and to face barriers doing so (OR: 2.87 (1.36, 6.06)). Encountering barriers was more likely among participants reporting no educational qualifications and those reporting symptoms of anxiety or depression. 199 participants reported a pregnancy in the last year. Pregnancies to young participants were less likely to be 'planned' (difference in mean LMUP score: -2.95;(-3.91, -1.99)). Less 'planned' pregnancies were associated with lower social grades and becoming unemployed. Discussion Young and vulnerable participants were more likely to report difficulties accessing reproductive services and less planned pregnancies during the pandemic. In navigating pandemic recovery, sexual health services should consider the needs of these at-risk groups.

ETHNIC VARIATIONS IN SEXUAL RISK BEHAVIOUR, SEXUAL HEALTH SERVICE USE AND UNMET NEED DURING THE FIRST YEAR OF THE COVID-19 PANDEMIC: AN ANALYSIS OF POPULATION-BASED SURVEY AND SURVEILLANCE DATA

Introduction Prior to the COVID-19 pandemic, STIs disproportionately affected some Black communities. We examined ethnic inequalities in sexual health during the pandemic. Methods Analyses were restricted to England residents aged 18-59. We included 5,240 sexually-experienced participants from Natsal-COVID survey Wave 2 (quasi-representative web panel survey) reporting one-year outcomes from March 2020- April 2021. We estimated weighted proportions and adjusted odds ratios (AORs) between ethnicity and sexual risk behaviour (condomless sex with new partner on first occasion), sexual health service (SHS) use, and unmet need (trying but failing to access SHS). Using GUMCAD national surveillance data from before (March 2019-March 2020) and during (March 2020-March 2021) the pandemic, we compared proportional differences in rates of STI tests and diagnoses by ethnicity. Results Compared to Natsal-COVID participants of White ethnicity, sexual risk behaviour (8%) was higher among participants of Mixed/Other (22%, AOR:2.26 [95% CI 1.08-4.73]) and Asian (15%, 1.58 [1.07-2.35]);SHS use (5%) was higher in Black (20%, 3.04 [1.75-5.28]) and Mixed/Other (20%, 2.64 [1.35-5.14]);and unmet need (2%) was higher in Black (11%, 5.01 [2.26-11.09]) and Asian (5%, 2.33 [1.11-4.90]) ethnicity. In GUMCAD, among people attending SHS, we observed similar reductions of around 50% in testing and diagnoses during the pandemic across different ethnic groups, although the greatest reduction was in people of Asian ethnicity (56% and 52% respectively). Discussion Two independent national data sources showed sexual health inequalities persisted during the first year of the pandemic with evidence of more unmet need among minority ethnicities, but further work is needed to assess whether these worsened.

WHAT IS THE ACCEPTABILITY OF ONLINE HIV PREEXPOSURE PROPHYLAXIS (PREP) CARE, DRAWING ON LESSONS LEARNED FROM REMOTE PREP PROVISION DURING THE COVID-19 PANDEMIC? FINDINGS FROM A QUALITATIVE STUDY WITH GAY, BISEXUAL AND OTHER MEN WHO HAVE SEX WITH MEN (GBMSM)

Introduction Online provision of PrEP care could help expand coverage to achieve HIV transmission elimination goals. An online PrEP clinic is being developed in Scotland, consisting of postal self-sampling for STIs and BBVs, an automated online consultation, and remote provision of medication. PrEP users' experiences of telephone-based PrEP care introduced during the Covid pandemic could inform the development of the online PrEP clinic. We explored the acceptability of the online PrEP clinic, drawing on PrEP users' experiences of telephone- based PrEP services. Methods We conducted semi-structured interviews with 15 GBMSM PrEP users recruited via an urban NHS sexual health service and online cohort (May-December 2021). Glasgow Caledonian University and NHS Scotland granted ethical approval. We used framework thematic analysis to analyse data. Results Participants felt that telephone-based PrEP care often lacked continuity, was burdensome, and felt impersonal. Despite this, participants felt the quality of care remained high and found the system easy to navigate. Participants found the proposed online PrEP clinic highly acceptable and identified potential benefits (e.g. convenience, privacy, and normalising PrEP) and challenges (e.g. fewer opportunities to ask questions and potentially forgetting to complete the self-sampling kit). Participants felt that SMS reminders, a helpline, and the ability to switch to in-person care when needed would support them to self-manage their PrEP care online. Discussion The proposed online PrEP clinic was highly acceptable to GBMSM, but integral support features will be needed to optimise its use, including personalisation and integration within existing care pathways to ensure continuity of care.

A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnostics

Addressing the COVID-19 pandemic has created many challenges for the Food and Drug Administration (FDA). One of the largest challenges in coping with COVID-19 has stemmed from the ongoing need for access to accurate diagnostic tests for the virus. FDA has well-established programs for reviewing in vitro diagnostic (IVD) tests. The agency also has had experience with accelerating the introduction of new IVDs in response to a public health emergency by granting Emergency Use Authorizations. However, no other new virus has overwhelmed FDA's resources and decision-making capacity the way the novel coronavirus has. This Article examines FDA's evolving approach to regulation of COVID-19 tests since the beginning of the pandemic, assesses the impact of FDA policies on IVD manufacturers and clinical laboratories and on the quality and availability of tests, and recommends areas for improvement. There is an urgent need for prompt FDA examination of its role in overseeing COVID-19 tests so the agency can evaluate what has gone well and much has and what can be improved. FDA should learn from COVID-19 how to regulate the new diagnostic tests needed for the next pandemic.

Exploring the data-sharing ecosystem in HIV care: Healthcare professionals' beliefs and practices

Background: Understanding data-sharing in HIV care is timely given the shift to remote consultations during COVID-19 and increasing expectations for self-management. We describe the 'data-sharing ecosystem' in HIV care by analysing HIV healthcare professional (HCP) beliefs and practices around sharing diverse types of service user and clinic-generated data across multiple contexts. Method: During February-October 2020, we conducted 14 semi-structured interviews with HCPs working in a large UK HIV outpatient service. Participants engaged in a card sorting task, sorting 33 data types routinely shared in HIV care into categories (comfortable/not comfortable/ not sure) across three data-sharing contexts: (a) from service users to HCPs in consultations;(b) HCPs to GPs;and (c) HCPs to non-HIV HCPs. Data were analysed thematically. Results: Over half (57%) of participants were female;57% were doctors. Participants had worked in HIV for 12 years on average. HCPs were comfortable with a wide range of data being shared with them by service users. Across all sharing contexts, HCPs were uncomfortable with sharing of service user photographs, perceiving them as not routinely shared, unnecessary, and potentially risking inadvertent sharing of inappropriate content. HCPs were comfortable sharing data with GPs and other non-HIV HCPs in two broad categories: (a) demographic data (e.g. age) and (b) non-sensitive data related to general health (e.g. sleep). HCPs were less comfortable sharing sensitive information about HIV status, sexual health, behaviour and identity, perceiving them as not relevant to care provided by other HCPs or as risking stigmatisation. Service user consent and relevance of data to sharing context were key determinants of data-sharing comfort. Conclusion: With a growing emphasis on self-management of HIV and on remote care provision, understanding the context of data-sharing in HIV care is increasingly important, particularly given the perceived durability of some current service changes as a result of COVID-19. We demonstrate the complex interplay of data types, relationship dynamics, and contexts of care provision that shape the data-sharing ecosystem in HIV care. Developing guidance on the sharing of service user and clinic-generated data in HIV care must account for these complexities.

Maintaining access to HIV PrEP in a pandemic: PrEP-user and healthcare professional perspectives on a telephone-based PrEP service

Background: To maintain access to PrEP during the COVID-19 pandemic our PrEP service (1000 PrEP-users) shifted to a largely telephone-based model (tele-PrEP). A service evaluation of this tele-PrEP service was conducted to explore the views and experiences of PrEP-users and sexual health care professionals (HCPs) to understand the benefits and drawbacks to inform future service delivery. Method: Parallel web-based anonymous surveys of PrEP-users and HCPs were developed using validated questions wherever possible. The PrEP-user survey was offered to those who had a tele-PrEP appointment between 13.11.2020-17.12.2020 and consented to participation. All HCPs conducting tele-PrEP appointments were invited to participate. Basic demographic data was captured. Data were analysed in Excel using descriptive statistics. Free text responses were thematically categorised using the Framework for a Systems Approach to Healthcare Delivery. Results: Sixty-two PrEP-users and 8 HCPs completed the surveys (response rate 55% and 89% respectively). Demographic characteristics of PrEP-user respondents were broadly representative of our whole PrEP-cohort. Most PrEP-user respondents booked their tele-PrEP appointment using the online booking tool (54/62) and for follow up appointments (52/62). The service was rated “excellent” or “good” by 61/62 PrEP-users, and 59/62 would recommend it to friends. Of the 62 respondents, 49 would like to continue with tele-PrEP in the future and 10/62 would prefer face-to- face appointments. PrEP-users identified convenience as a key benefit along with access to PrEP with reduced potential for COVID-19 exposure. Drawbacks were largely technological, including poor connection or issues with online booking. All HCPs felt that tele-PrEP allowed them to assess patients safely and confidently. Seven of eight HCPs felt well supported to undertake tele-PrEP appointments. One HCP expressed a preference for face-to- face appointments. HCPs also rated its convenience highly and felt it enabled better use of limited face-to- face clinic capacity. However, HCPs thought that tele-PrEP might create barriers for vulnerable patients, particularly those with low digital, health and/ or English-language literacy. Conclusion: Tele-PrEP is feasible and highly acceptable. While most respondents rated the service highly, others identified a need or preference for face-to- face appointments. Therefore, our service will continue tele-PrEP whilst ensuring availability of face-to- face care for those who require or request it.

Do gbmsm's preferences for in-person, telephone or digital sexual healthcare vary according to health concerns and symptoms? a cross-sectional survey

Background As sexual healthcare moves online, it's important to understand the needs and preferences of groups with a higher burden of poor sexual health, to ensure equitable services. We explored gay, bisexual, and other men who have sex with men's [GBMSM] preferences for in-person, telephone, and online provision of sexual healthcare and whether preferences change in the presence of symptoms and/or concerns about STI risk. Methods Cross-sectional online survey of GBMSM in Scotland recruited from sexual-social media 12/2019-03/2020 (pre- Covid-19 pandemic). Participants were asked their preferences (or no preference) for accessing appointment booking, providing sexual/medical history, and accessing HIV/STI results in two scenarios: routine check-up (no symptoms/concerns);and concerned about new symptoms/possible infection. Data were analysed using Pearson chi-squared, McNemar-Bowker, and post-hoc McNemar tests. Results 755 GBMSM participated, median age 39, 71.4% completed higher education, 69.9% were White Scottish. When accessing a routine check-up, proportions preferring in person, telephone and online care respectively were: booking appointments [27/755 (3.6%), 113/755 (15.0%), 520/755 (68.9%)];reporting sexual behaviour [184/748 (24.6%), 39/ 748 (5.2%), 382/748 (51.1%)];reporting symptoms [254/747 (34.0%), 46/747 (6.2%), 308/747 (41.2%)];reporting medication [163/745 (21.9%), 46/745 (6.2%), 358/745 (48.1%)];receiving HIV results [200/699 (28.6%), 73/699 (10.4%), 304/ 699 (43.5%)];receiving STI results [143/746 (19.2%), 96/746 (12.9%), 361/746 (48.4%)]. A significant proportion of participants' preferences changed across all elements of care measured, when concerned about symptoms or infection (p<0.005). Post-hoc analyses suggest that these changes were mostly attributed to a shift in preference from online to inperson care in the presence of symptoms/STI risk. Conclusions In this online-recruited sample of highly educated, older GBMSM, online care was highly acceptable but a significant proportion preferred in-person care in the presence of symptoms/STI risk. Choice in sexual healthcare provision is essential as GBMSM's preferences are not static and appear highly associated with emotional context..

Maintaining access to HIV prep in a pandemic: Prep-user and health care professional perspectives on a telephone-based prep service

Background To maintain access to PrEP during the COVID-19 pandemic our PrEP service (1000 PrEP-users) shifted to a largely telephone-based model (tele-PrEP). Objectives To conduct a service evaluation of tele-PrEP, exploring the views and experiences of PrEP-users and sexual health care professionals (HCPs), to understand benefits and drawbacks to inform future service delivery. Methods Parallel, web-based, anonymous surveys of PrEP-users and HCPs were developed using validated questions wherever possible. The PrEP-user survey was offered to people who had a tele-PrEP appointment between 13.11.2020-17.12.2020 and consented to participate. All HCPs conducting tele-PrEP appointments were invited to participate. Basic demographic data was captured. Data were analysed in Excel using descriptive statistics. Free text responses were thematically categorised using the Framework for a Systems Approach to Healthcare Delivery. Results Sixty-two PrEP-users and 8 HCPs completed the surveys (response rate 55% and 89% respectively). Demographic characteristics of PrEP-user respondents were broadly representative of our whole PrEP-cohort. Tele-PrEP was rated 'excellent' or 'good' by 61/62 PrEP-users, and 59/62 would recommend it to friends. PrEP-users identified convenience as a key benefit along with access to PrEP with reduced potential for COVID-19 exposure. Drawbacks were largely technological, including poor connection or issues with online booking. All HCPs felt that tele-PrEP allowed them to assess patients safely and confidently. HCPs also rated its convenience highly and felt it enabled better use of limited face-to-face clinic capacity. However, HCPs thought that tele-PrEP might create barriers for vulnerable patients, particularly those with low digital, health and/or English-language literacy. One HCP and 10/62 PrEP-users expressed a personal preference for face-toface appointments. Conclusion Tele-PrEP is feasible and acceptable. While most respondents rated the service highly, others identified a need/ preference for face-to-face appointments. Therefore, our service will continue tele-PrEP whilst ensuring availability of faceto- face care for those who require or request it..

Exploring the data-sharing ecosystem in HIV care: healthcare professionals' beliefs and practices

Background Understanding data-sharing in HIV care is timely given the shift to remote consultations during COVID-19. We describe the 'data-sharing ecosystem' in HIV care by analysingHIV healthcare professional (HCP) beliefs and practices around sharing diverse types of service user and clinic-generated data across multiple contexts. Methods During February-October 2020, we conducted 14 semi-structured interviews with HCPs working in a large UK HIV outpatient service. Participants engaged in a card sorting task, sorting 33 data types routinely shared in HIV care into categories (comfortable/not comfortable/not sure) across three data-sharing contexts: (a) service users to HCPs in consultations;(b) HCPs to GPs;(c) HCPs to non-HIV HCPs. Data were analysed thematically. Results Over half (57%) of participants were female;57% were doctors. Participants had worked in HIV for 12 years on average. HCPs were comfortable with a wide range of data being shared with them by service users. Across all sharing contexts, HCPs were uncomfortable with sharing of service user photographs, perceiving them as not routinely shared, unnecessary, and potentially risking inadvertent sharing of inappropriate content. HCPs were comfortable sharing data with GPs and other non-HIV HCPs in two broad categories: (a) demographic data (e.g. age) and (b) non-sensitive data related to general health (e.g. sleep). HCPs were less comfortable sharing sensitive information about HIV status, sexual health, behaviour and identity. Service user consent and relevance of data to sharing context were key determinants of data-sharing comfort. Conclusion Understanding the context of data-sharing in HIV care is increasingly important given the shift to remote consultations and expectations for self-management. We demonstrate the complex interplay of data types, relationship dynamics, and contexts of care provision that shape the data-sharing ecosystem in HIV care. Developing guidance on the sharing of service user and clinic-generated data in HIV care must account for these complexities.

O05.2 A mixed-method investigation into challenges in accessing sexual and reproductive health (SRH) services in Britain during the COVID-19 pandemic (Natsal-COVID)

BackgroundCOVID-19 restrictions led to widespread disruption of SRH services in Britain following the first national lockdown (23/3/2020). One-in-ten people who tried to access SRH services during reported being unable to do so (Natsal-COVID). We used mixed-methods research to quantify unmet need and explore its context and impact.Methods6,657 participants aged 18–59 years completed a web-panel survey (29/07–10/08/20). Quota-based sampling and weighting enabled a quasi-representative population sample to be achieved. Quantitative analysis focused on participants’ challenges accessing contraception and STI-related services since lockdown. We conducted 23 in-depth interviews with participants, 15 who reported not receiving an SRH service and eight who discussed this in a different topic interview.ResultsReasons for not receiving STI-related (n=103) or contraception services (n=144) despite need included that appointments were unavailable (STI-related services: 28.6% (95%CI:19.5–39.8)/Contraception services 36.3% (28.1% – 45.4%)), were cancelled (22.8% (14.9%- 33.3%)/23.9% (16.8%-32.8%) or services were closed (21.2% (13.7%-31.4)/26.1% (19.1%-34.5%). Discomfort with using online/telephone services was more common amongst those not receiving STI-related services 26.0% (17.4%-36.9%) than for contraception services 6.7% (3.4%-12.8%).Interviewees described how some services were unavailable, while others were disrupted. Many were offered and received alternatives to in-person service (e.g. telephone/online) and some had to use different contraceptive methods. Most understood attempts to limit SARS-CoV-2 transmission and found alternatives convenient, though others saw them as inferior due to interaction limitations. Tenacity was required to access some services. Several participants described how they had avoided or deprioritised their own needs. Fears of contracting COVID-19 and of judgement for having sex against restrictions deterred help-seeking.ConclusionWhile some people were unable to access an anticipated service, many were offered alternatives with varied consequences. Services may need to adapt further to improve access by offering efficient face-to-face and remote provision while emphasising lack of judgement and validating help seeking.

O04.4 Measuring impacts of COVID-19 on sexual and reproductive health service use in Britain: findings from a large, quasi-representative survey (Natsal-COVID)

BackgroundSexual and reproductive health (SRH) services in Britain shifted rapidly in response to COVID-19 and the first national lockdown. We investigated SRH service access and unmet need in Britain in the 4-months following lockdown (23/03/2020) to inform service delivery during and after the pandemic.Methods6,657 participants aged 18–59 years completed a web-panel survey (29/07/2020–10/08/2020). Quota-based sampling and weighting enabled a quasi-representative population sample. We estimated the prevalence of reported SRH service access and failed access, and calculated age-adjusted odds ratios (aOR) for sexually-experienced (≥1 sexual partner/lifetime;n=3,065) and sexually-active (≥1 sexual partner/past year;n=2,752) participants aged 18–44 years.Results20.8% (95%CI:19.3%-22.3%) of sexually-experienced participants reported accessing ≥1 SRH service in the 4-months from lockdown. 9.7% (8.6%-10.8%) reported being unable to access a service they needed, though many of these participants (76.4%) also reported successful access. 14.8% (13.1%-16.6%) of sexually-experienced women reported accessing contraception services since lockdown, and this was more likely for younger women (OR, 18–24 vs. 35–44 years: 2.96 (1.95 – 4.49)). Among sexually-active participants, 4.8% (4.0%-5.7%) reported accessing STI-related services (STI/HIV testing and follow-up care) and this was higher in those aged 18–24 years (10.1%). Participants reporting any new condomless partner(s) since lockdown were more likely to report accessing STI-related services (aOR, men: 23.77 (11.55–48.92), women: 10.53 (3.94–28.15)) and, amongst men, to report a failed attempt (aOR 13.32 (5.39–32.93)). Among those reporting STI testing (n=106), 33.4% (24.1%-44.2%) did so online, 31.5% (22.0%-42.9%) by phone, 43.9% (33.4%-55.0%) in-person, and 14.8% (8.3%-25.2%) via video consultation.ConclusionOur findings are consistent with SRH services in Britain adapting rapidly in response to COVID-19 and prioritising access for those in need. However, a significant proportion of participants reported difficulty accessing care, suggesting that services may need to adapt further to address and prevent a backlog of need among some high-risk groups.