Long-acting (LA) antiretroviral therapies for human immunodeficiency virus (HIV), such as injectable formulations of cabotegravir and rilpivirine (CAB+RPV LA), are now available. Considering the limited data on the out-of-hospital administration of this combination, evaluating the implementation strategies needed is essential to support future clinical efforts. To gather data on barriers and facilitators of implementation for CAB+RPV LA in alternative outpatient facilities, this study used qualitative interviews informed by the Consolidated Framework for Implementation Research (CFIR), with 13 staff participating in the HOLA study (NCT06185452). Data analysis followed qualitative descriptive methods, assisted by Atlas.ti software version 22. The study adhered to the COREQ guidelines. Findings reveal five main factors to consider for implementation: operational and infrastructure adaptations, integrated management of human and organizational resources, need for coordination and follow-up, professional attitudes and work environment, and patient experience and patients’ needs perceived by professionals. This study emphasizes the comprehensive operational and infrastructure adaptations, adequate staff training, and supportive professional environment required for the successful implementation of CAB+RPV LA, while considering patients’ needs throughout the externalization process (trial registration number: NCT06643897).

Introduction The HOLA study is a 12-month randomised, hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study including virologically suppressed people living with HIV (PWH). HOLA, which started in September 2023, evaluates acceptability, appropriateness, feasibility and satisfaction of out-of-hospital administration of cabotegravir and rilpivirine long-acting (CAB+RPV LA). Methods A total of 110 PWH who are already under treatment with CAB+RPV LA or switch their antiretroviral therapy to CAB+RPV LA will be recruited from two main hospitals in Barcelona (Germans Trias I Pujol and Vall d’Hebrón) and Costa del Sol Hospital, in Marbella. The patients will be randomised 1:1 into a hospital group (administration of CAB+RPV LA in the hospital) and the outpatient group (out-of-hospital administration), including community or primary care centres. The main objectives of the study are to compare the acceptability at month 12 of the administration of CAB+RPV LA in and out-of-hospital centres from the perspective of patients, and assess and compare the safety and tolerability of CAB+RPV LA. The study takes place at nine clinical units in Catalonia and Andalusia (three tertiary hospitals (recruiting centres), one community centre, one sexually transmitted infection clinic and four primary care centres). Ethics and dissemination The current publication refers to V.3.0 of the protocol, with issue date 14 April 2024, as approved by the Comité de Ética de la Investigación con medicamentos del Hospital Universitari Germans Trias i Pujol (approval number AC-23-042-HGT-CEIM). The clinical trial will be conducted according to the principles of the Declaration of Helsinki, Fortaleza, Brazil, October 2013. This study will be conducted according to Spanish regulations regarding clinical trials (Royal Decree 1090/2015) and biomedical investigations (Organic Law 14/2007 of biomedical investigation and the Royal Decree 1716/2011), and the Clinical Trial Regulation (Regulation EU No 536/2014). Confidentiality requirements will follow the required Data Protection legislation. Enrolment completion in the study is expected by the end of May 2024, with an end of study expected in May 2025. Results emerging from this study will be reported in HIV national and international meetings as well as published in international journals with a high impact factor. If the outcome is deemed positive, we will also develop and propose policy guidelines for the integration of the administration of CAB+RPV LA in alternative outpatient facilities into the standard of care in the HIV care pathway. Trial registration number NCT06185452/EUCT number: 2023-503963-41-00.

Introduction: Maintaining adherence and access to antiretroviral treatment is basic for good management of people with HIV (PWH), while enhancing patient satisfaction. With the aim of shifting from drug-centered into patient-centered care and integrating care interventions into community settings, here we share an outpatient hospital pharmaceutical care implementation model for PWH. This model involves the delivery of medication through a community center, BCN-Checkpoint, using a proprietary app and coordinated with automated locker systems. Methods: During the pre-implementation phase the circuit was defined and seven steps were considered critical for successful implementation: (1) assignation of teams and roles; (2) adaptation of the self-developed app; (3) development of a patient journey map; (4) locker installation and system integration with data from the electronic records; (5) staff training; (6) review of data protection regulations; (7) simulation tests. A two-phase simulation—with fictitious users and with real ones—validated the system. The implementation phase included an initial pilot study, in which 46 patients were included in the project. Results: System uptake was high, with strong adherence to the dispensing pathway; only five discontinuations due to personal preferences or availability of alternative dispensing pathways. Several barriers to implementation emerged, primarily categorized into technical issues, process and operational challenges, coordination, and user-related difficulties. However, a communitarian setting, flexible attention times and protocols, and the strong intersectoral collaboration between specialists are believed to increase patient retention and overall satisfaction. Conclusions: The implementation of an outpatient dispensing hospital medication model using an app and automated locker systems is feasible, considering detail to procedures, timely adaptations, and staff training.

Introduction: People with the human immunodeficiency virus (PWH) who were diagnosed long ago are more prone to age-related conditions and comorbidities than the general population. We hypothesized that older PWH have endocrine abnormalities that may influence the patient’s health status. Methods: Mean hormonal values across the thyrotropic, somatotropic, corticotropic, and gonadal axis, and percentage of subjects with abnormal values, were compared between PWH aged ≥50 years (n=30) and people without HIV (n=30) (Over50 cohort). Clinical factors were also analyzed as independent variables. Results: PWH had a higher prevalence of comorbidities (36.67% PWH and 20.69% controls had ≥3 comorbidities). Male PWH exhibited lower estradiol levels than male controls (29.75±7.68 pg/mL vs. 35.45±10.04 pg/mL; p=0.0041). Abnormal concentrations of testosterone were found in 35% of male PWH compared to 55% of male controls (mostly above reference values). Cortisol levels were significantly lower among PWH (9.97±4.33 μg/dL vs. 13.56±3.39 μg/dL; p=0.002); 16.6% of PWH exhibited abnormally low levels (<5 μg/dL), compared to 0% of controls, and 3 PWH met criteria for a definitive diagnosis of adrenal insufficiency (<3.6 μg/dL). For the somatotropic axis, growth hormone (GH) levels were significantly lower in male PWH than in controls (p=0.0394). No significant differences were found in relation to the thyroid axis. Conclusion: Hormones are generally similar between the chronic PWH who are receiving ART treatment and the general control population, except for cortisol in both sexes and testosterone and estradiol in men. Some special attention should be given to cortisol in PWH due to a presumably higher risk of adrenal complications.