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.
The OOH (Out-Of-Hospital) study is a 24-week, open-label, randomized pilot study assessing the feasibility and impact of decentralized HIV care in a community setting (BCN Checkpoint), focusing on patient satisfaction and experience and carbon footprint. Participants are randomized 2:1 to receive medical care and pick up ART at the BCN Checkpoint community centre (OOH Group) or at the Hospital (Hospital Group). Medical care encompass medical follow-up visits, collection of ART medication, vaccinations and analytical tests. Those who are randomized to the OOH Group are attended by the same physician they had at the hospital, and ART is collected every two months through self-automated lockers. Those who are randomized to the Hospital Group are attended as usual, at the hospital, and ART is collected every two months at the pharmacy service from the hospital. For both Groups, study visits are scheduled at baseline, week 8, week 16, and week 24. The baseline visit includes medical evaluation and randomization; visits at weeks 8 and 16 consist exclusively of ART collection, while the week 24 visit includes ART collection, a medical consultation, and blood testing. After the 24-week study period, all participants have the option to switch their medical care to the other centre.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
54
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.
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
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.
Time frame: 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
Compare between groups the median of the obtained scores from items 1 to 7 in a patients' expectations and satisfaction questionnaire self-developed ad hoc for this study at week 24. Items 1 to 7 of the questionnaire consist of a 5-point likert scale were 1 corresponds to "completely disagree" and 5 corresponds to "completely agree".
Time frame: week 24
To evaluate and compare patients' quality of life
Compare between groups the percentage of participants who report a very good or good quality of life, obtaining a score between 1 or 2 on the Medical Outcomes study HIV Health Survey (MOS-HIV) scale at week 24. MOS-HIV quality of life and transitory health items were quantified separately, and the score ranged from 1 (best) to 5 (worse).
Time frame: week 24
To evaluate and compare patients' perception of illness severity.
Compare between groups the percentage of patients with moderate illness severity perception (Score 42 to 49) and patients with severe illness severity perception (score ≥ 50) using the 8-item Brief Illness Perception Questionnaire, were each item consists of a 10-point scale ranging from 0 (no influence) to 10 (major influence). Additionally, among illness perception criteria, Cognitive Representation is obtained from the sum of items 1-5; the Emotional Representation is obtained from the sum of items 6 and 8; and the item 7 corresponds to the Disease Understanding dimension.
Time frame: 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.
Compare changes at week 24 in the median of the obtained scores from all items in the health staff's expectations and satisfaction questionnaire self-developed ad hoc for this study at week 24. Items 1 to 7 of the questionnaire consist of a 5-point likert scale were 1 corresponds to "completely disagree" and 5 corresponds to "completely agree". item No. 8 consists of a 10-point scale were 10 is the maximum expression of satisfaction and 1 is the lowest rank.
Time frame: week 24
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