Pilot Study to Evaluate the Decentralization of Patient Care Among People With HIV in Out-of-hospital Settings
OOH
Sponsor study identifier
interventional
54
1 country
1
Study Start
November 7, 2024
Actual (reported)Primary Completion
January 20, 2026
Actual (reported)Study Completion
January 20, 2026
Actual (reported)The goal of this 24-week, open-label, randomized pilot study is to assess the feasibility and impact of decentralized HIV care in a community setting (BCN Checkpoint), focusing on patient satisfaction and experience and carbon footprint. The main question it aims to answer is patients' satisfaction with the medical care at week 24, derived from decentralizing the patient care compared to continuing with the usual follow-up at the hospital. Participants will attend a medical follow-up visit at week 24, an analytical test visit at week 24, and collect ARV every 8 weeks, at the center assigned during randomization (Hospital or BCN Checkpoint); as well as to fill a series of questionnaires at baseline and week 24.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 20, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2024
Actual (reported)January 20, 2026
Actual (reported)January 20, 2026
Actual (reported)August 19, 2026
Actual (reported)August 28, 2026
Actual (reported)To evaluate and compare the benefits in terms of patients' satisfaction derived from decentralizing the patient care versus continuing with the usual follow-up.
Compare between groups the percentage of patients who, in the item No. 8 of the patients' expectations and satisfaction questionnaire self-developed ad hoc for this study, have indicated ≥ 8 points of satisfaction at week 24. This item consists of a 10-point scale were 10 is the maximum expression of satisfaction and 1 is the lowest rank.
week 24
To evaluate and compare patients' expectations regarding a positive impact of decentralizing the patient care in the following areas: treatment adherence, visits follow-up, disease perception, physical and emotional QoL, family and social relationships
week 24
Includes medical follow-up visits, collection of ARV and analytical tests, as per usual rutinary practice, in Hospital.
Evaluates the benefits of implementing the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point.
Decentralization of medical care includes: medical follow-up visits, collection of ARV and analytical tests. As per usual rutinary practice, medication will be collected every two months at both facilities. The study will have a duration of 24 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
54 participants (actual enrollment reported by the registry).
First Submitted
August 19, 2026
First Posted
August 28, 2026
Study Start
November 7, 2024
Actual (reported)Finishing HIV Project
To evaluate and compare patients' quality of life
week 24
To evaluate and compare patients' perception of illness severity.
week 24
To evaluate and compare expectations and satisfaction among health staff (a nurse and a physician) regarding the positive impact of decentralizing the patient care.
week 24
Distance to care facility (out-of-hospital facility or hospital)
24 weeks
Time to care facility (out-of-hospital facility or hospital)
24 weeks
Carbon footprint associated with healthcare visits
week 24
Contact the study team to confirm eligibility.
Primary Completion
January 20, 2026
Actual (reported)Study Completion
January 20, 2026
Actual (reported)Last Updated
August 28, 2026
Record last verified: 2026-08
The raw and individual personal data are protected and not available to anyone due to applicable data privacy legislation: The processing of the data are subjected to current legislation as regards data protection (LOPD, The Organic Law 3/2018 of 5 December on the Protection of Personal Data and the Guarantee of Digital Rights complementary to the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data). The raw dataset that supports the findings of this study are available from Fundació FLS de Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la Salut i La Ciència but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Raw datasets results are however available for other researchers from the authors upon reasonable request.
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Source: ClinicalTrials.gov.
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