Preventing loss of autonomy has become a public health issue due to the increase in healthcare costs associated with ageing. It has become even more pressing with the arrival of the baby-boomer generation. This has given rise to several initiatives. This is the background to the VIVADOM project. The project provides a complete kit for older adults aged 60 years and over living at home. First, the kit includes a technological package (telecare, light path and digital tablet). Then, these older adults benefit from personalised human support provided by postal workers trained in gerontology. The aim of this study will be to carry out a health economic assessment (HEA) of the VIVADOM project as part of the prevention of frailty and/or dependency (by comparing beneficiaries of the complete kit with non-beneficiaries). The comparator will be the fact of not benefiting from the complete kit. In addition, the efficiency of the project in preventing falls and cognitive problems will be studied. We will calculate three incremental cost-effectiveness ratios (ICER) for these three issues.

The economic model used will be the Markov model. Transition probabilities, average costs and average quality-adjusted life year (QALY) will be calculated for the two groups being compared. The ICER will be obtained by dividing the difference in average costs by the difference in average QALYs. Finally, ICERs will be compared with willingness-to-pay (WTP) to assess the efficiency of the system. Thus, the VIVADOM project will be efficient when these ICERs are lower than the WTP. Univariate and probabilistic sensitivity analysis will be carried out to ensure the robustness of the analysis results.

The HEA of the VIVADOM project has been approved by the research unit of the University of Limoges in France. The results will be published in a peer-reviewed journal and presented at relevant national and international conferences.

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.

We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.

Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.

Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.

V. 2.0 dated 21 May 2024.

NCT03194308.

Major depressive disorder (MDD) is a major global healthcare challenge. This is, in part, due to the lack of treatment response and chronic course of MDD. Such a course of illness is often termed treatment-resistant depression (TRD) and is seen in over one-third of people with MDD. Reasons for treatment resistance are not well established, nor is the definition of TRD. Duration and severity of depression, however, are associated with TRD and are also associated with cognitive deficits. Thus, TRD could be particularly prone to cognitive deficits and at heightened risk for neuroprogression. While the cognitive profile of MDD has been investigated in several systematic reviews, no systematic review of cognition in TRD exists to date. The present study will fill this gap in the literature. It is expected that TRD will show more severe cognitive deficits than generally reported in MDD and deficits in all cognitive functions are expected.

A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be performed of the databases Embase, Pubmed/MEDLINE, PsychINFO and Cochrane including peer-reviewed studies on humans using standardised cognitive tests. Pilot searching was performed in January 2025 and the full search will be commenced in June 2025, with additional searches following completion. Where sufficient data are reported, a meta-analysis comparing deficits in TRD with MDD and healthy control participants will be performed; alternatively, effects based on norms will be calculated. Meta-regression, subgroup and sensitivity analyses will be conducted to explore moderators that are sufficiently reported in the literature. The quality of studies will be assessed by the Newcastle-Ottawa Scale.

Ethical approval is not necessary to perform the study, and results will be presented at a suitable conference and published in a peer-reviewed journal.

CRD42024538898.