ObjectivesA novel long-acting regimen (LAR) of cabotegravir and rilpivirine for HIV treatment requires dosing every 2 months instead of daily. We assessed what proportion of people living with HIV and physicians would be interested in trying and offering LAR respectively and why.Methods688 people living with HIV on treatment, and 120 HIV physicians completed web-based surveys in Germany, Italy, the UK and France during 2019. Balanced description of a hypothetical LAR regarding efficacy, administration and possible side effects were provided. The hypothetical long-acting injections were assumed to be cost-neutral to current daily oral antiretrovirals. Interest of people living with HIV in trying (‘very’/’highly’) and physicians’ willingness to offer (‘definitely’/’probably’) this LAR in different situations, with perceived benefits/concerns was measured.ResultsOf people living with HIV, 65.8% were interested in trying LAR. The majority (~80%–90%) of those with unmet needs felt LAR would help, including those with strong medical needs (malabsorption and interfering gastrointestinal conditions), suboptimal adherence, confidentiality/privacy concerns and emotional burden of daily dosing. Of physicians, percentage willing to offer LAR varied situationally: strong medical need (dysphagia, 93.3%; malabsorption, 91.6%; interfering gastrointestinal issues, 90.0%; central nervous system disorders, 87.5%); suboptimal adherence (84.2%); confidentiality/privacy concerns (hiding medications, 86.6%) and convenience/lifestyle (84.2%). People living with HIV liked LAR for not having to carry pills when travelling (56.3%); physicians liked the increased patient contact (54.2%). Furthermore, 50.0% of people living with HIV perceived LAR would minimise transmission risk and improve their sexual health. The most disliked attribute was scheduling appointments (37.2%) and resource constraints (57.5%) for people living with HIV and physicians, respectively. Physicians estimated 25.7% of their patients would actually switch.ConclusionProviders and people living with HIV viewed the described LAR as addressing several unmet needs. Alternative treatment routes and especially LAR may improve adherence and quality of life.

INTRODUCTION Current antiretroviral therapies (ARTs) require daily oral dosing, which is a challenge for some people living with HIV (PLHIV). Measures of treatment needs that are associated with daily oral ARTs have been identified in studies/ interviews with healthcare professionals (HCPs) and PLHIV, and are grouped in four main categories: 1) medical conditions interfering with daily oral administration, 2) suboptimal adherence, 3) confidentiality concerns, and 4) emotional wellbeing related to daily tablet requirements. We quantified these categories to assess the potential benefits of alternatives to daily oral ARTs such as long-acting injectable regimens. METHODS Two separate online studies were completed by HCPs (n=120) and PLHIV (n=698) in France, Germany, Italy and the UK, in 2019. HCPs reported the number and percentage of their patients with challenges; unit of analysis among PLHIV was the respondents (%). Descriptive analyses were performed with R 3.6.1. RESULTS HIV physicians reported managing a mean of 299 (SD=177) patients, of whom 85.7% were on ART. Among PLHIV, 98.6% (688/698) were currently on ART, with mean age of 40.9 (SD=12.0) years, and 66.4% men. HCPs estimated that 10-15% of their patients were affected by each medical condition identified as interfering with daily oral administration. HCPs further estimated that 33.6% of their patients were suboptimally adherent. 'Non-adherence for any non-medical reason' was reported by HCPs as the primary cause of virologic failure. Of surveyed PLHIV on ART, 43.3% (298/688) reported hiding their medication and 29.7% (204/688) indicated they had never shared their HIV status with others. Furthermore, some PLHIV reported that having to remember to dose at the right time every day was stressful (27.3%; 188/688) and many saw their tablets as a daily reminder of HIV (45.1%; 310/688). CONCLUSIONS A significant proportion of PLHIV struggle with daily oral ART because of medical and/or HIV-specific issues. Alternatives to daily oral ARTs have the potential to improve treatment adherence and quality of life in PLHIV.

Background The daily oral dosing requirement for antiretroviral therapy (ART) may be challenging for some people living with HIV (PLWHIV) with comorbid conditions, confidentiality concerns or pill fatigue. We investigated suboptimal adherence from the perspective of PLWHIV and HIV physicians. Methods PLWHIV on ART (n = 688) and HIV physicians (n = 120) were surveyed during 2019 in France, Germany, Italy and the UK. Suboptimal adherence was a report the participant missed taking their dose as prescribed ‘Sometimes’/‘Often’/‘Very often’. Physicians’ interest in offering a hypothetical long-acting HIV regimen for suboptimally adherent patients was assessed. Descriptive and multivariable analyses were performed (P < 0.05). Results Of PLWHIV, 23.8% (164/688) reported suboptimal adherence vs. providers’ estimated prevalence of 33.6% (SD = 28.8). PLWHIV-reported prevalence of specific suboptimal adherence behaviors were: mistimed dose [16.1% (111/688)]; missed a dose [15.7% (108/688)]; dosed under wrong conditions [e.g. food restrictions, 10.5% (72/688)] and overdosed [3.3% (23/688)]. Odds of suboptimal adherence were higher among those with vs. without a report of the following: dysphagia (AOR = 3.61, 95% CI = 2.28–5.74), stress/anxiety because of their daily dosing schedule (AOR = 3.09, 95% CI = 1.97–4.85), gastrointestinal side effects (AOR = 2.09, 95% CI = 1.39–3.15), neurocognitive/mental health conditions (AOR = 1.88, 95% CI = 1.30–2.72) or hiding their HIV medication (AOR = 1.51, 95% CI = 1.04–2.19). Of providers, 84.2% indicated they Definitely/Probably will offer a hypothetical long-acting HIV regimen ‘for patients who have suboptimal levels of adherence to daily oral therapy (50–90%) for non-medical reasons’. Conclusions Dysphagia, stressful daily oral dosing schedule, gastrointestinal side effects, neurocognitive/mental health conditions and confidentiality concerns were associated with suboptimal adherence in our study. Adherence support and alternative regimens, such as long-acting antiretroviral therapies, could help address these challenges.

Introduction Cabotegravir and Rilpivirine (CAB+RPV-LA) is recommended as a treatment for HIV-1 allowing people living with HIV to receive two-monthly injectable treatment, rather than daily pills. Providing injectable therapy in a system designed to provide and manage patients on oral treatments poses logistical challenges namely how resources are used to accommodate patient preference within constrained health economies with capacity limitations. In this pragmatic multi-centre study, we aim to understand the implementation of CAB-RPV-LA administration in two settings via mixed methods to explore perspectives of participants and the clinical team delivering CAB+RPV-LA. Methods and Analysis Women, racially minoritised people and older people are chronically under-represented in HIV clinical trials so the ILANA trial has set recruitment caps to ensure recruitment of 50% women, 50% ethnically-diverse people and 30% over 50 years of age to include a more representative study population. Utilising a mixed-methods approach, the primary objective is to identify and evaluate the critical implementation strategies for CAB+RPV-LA in both hospital and community settings. Secondary objectives include evaluating feasibility and acceptability of CAB+RPV-LA administration at UK clinics and community settings from the perspective of HIV care providers, nurses, and representatives at community sites, evaluating barriers to implementation, the utility of implementation strategies, and adherence. Ethics and Dissemination Ethical approval has been obtained from the Health Research Authority Research Ethics Committee (REC reference: 22/PR/0318). The dissemination strategy has been formulated with the SHARE Collaborative Community Advisory Board in order to maximise the impact of this work on clinical care and policy. This strategy draws upon and leverages existing resources within the participating organisations, such as their academic infrastructure, professional relationships and community networks fully. The strategy will particularly harness the Public Engagement Team and press office to support dissemination of findings. Registration Number ClinicalTrials.gov Identifier:NCT05294159

IntroductionCabotegravir and rilpivirine (CAB+RPV long-acting (LA)) is recommended as a treatment for HIV-1 allowing people living with HIV to receive 2 monthly injectable treatment, rather than daily pills. Providing injectable therapy in a system designed to provide and manage study participants on oral treatments poses logistical challenges namely how resources are used to accommodate patient preference within constrained health economies with capacity limitations. In this pragmatic multicentre study, we aim to understand the implementation of CAB-RPV-LA administration in two settings via mixed methods to explore perspectives of participants and the clinical team delivering CAB+RPV LA.Methods and analysisWomen, racially minoritised people and older people are chronically under-represented in HIV clinical trials so the ILANA trial has set recruitment caps to ensure recruitment of 50% women, 50% ethnically diverse people and 30% over 50 years of age to include a more representative study population. Using a mixed-methods approach, the primary objective is to identify and evaluate the critical implementation strategies for CAB+RPV LA in both hospital and community settings. Secondary objectives include evaluating feasibility and acceptability of CAB+RPV LA administration at UK clinics and community settings from the perspective of HIV care providers, nurses and representatives at community sites, evaluating barriers to implementation, the utility of implementation strategies and adherence.Ethics and disseminationEthical approval has been obtained from the Health Research Authority Research Ethics Committee (REC reference: 22/PR/0318). The dissemination strategy has been formulated with the SHARE Collaborative Community Advisory Board to maximise the impact of this work on clinical care and policy. This strategy draws on and leverages existing resources within the participating organisations, such as their academic infrastructure, professional relationships and community networks. The strategy will leverage the Public Engagement Team and press office to support dissemination of findings.Trial registration numberNCT05294159.