The experimental EuroQol Toddler and Infant Populations (EQ-TIPS) instrument is currently under development as a health-related quality of life (HRQoL) measure for toddlers and infants aged 0–36 months. Using this protocol, researchers can conduct surveys with discrete choice experiments (DCEs) that examine the key properties of HRQoL instruments, specifically whether severity aligns with preferences across each attribute and the extent to which attributes influence choices. To demonstrate this protocol, we will conduct two waves of DCE surveys using different choice tasks and a common scenario (a 1-month health episode for a 1-year-old child).

In the first wave (a general population sample of 400 Australian adults; 14 kaizen tasks each), respondents will view a single EQ-TIPS-five-level (v3.0) profile for each task and be asked to make a series of choices that sequentially alleviate the child’s health problems. Using this exploratory evidence, we will assess whether EQ-TIPS severity aligns with preferences and the extent to which each attribute level influences choices (ie, main effects). In the second wave (1000 Australian adults; 28 paired comparisons), respondents will see two EQ-TIPS profiles for each task and be asked to choose between them. Using this confirmatory evidence, we will compare the main effects and their uncertainty by wave. For each DCE, we will estimate a main-effects conditional logit model and test for differences in effects using cluster bootstrap techniques. As sensitivity analyses, we will evaluate the effects of task sequence, attribute order and sample size on uncertainty in each wave.

The independent review board at Includovate evaluated the application for ethical clearance and approved the study on 19 February 2025. To disseminate our findings, we will prepare multiple manuscripts for publication in peer-reviewed journals and present highlights at scientific meetings, such as the EuroQol Plenary Meeting and the International Academy of Health Preference Research.

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).

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).

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.

NCT06185452/EUCT number: 2023-503963-41-00.