Pilot Study to Evaluate the Decentralization of Patient Care Among People With HIV in Out-of-hospital Settings (OOH)
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.
Study Overview
Status
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitario Germans Trias i Pujol
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Stable ARV treatment for ≥6 months with oral medications including:
- Biktarvy (bictegravir/emtricitabina/tenofovir alafenamida)
- Dovato (dolutegravir/lamivudina)
- Juluca (dolutegravir/rilpivirina)
- dolutegravir + emtricitabina/tenofovir
- Symtuza (darunavir/cobicistat/emtricitabina/tenofovir alafenamida)
- Undetectable HIV viral load for ≥6 months.
- Good treatment adherence according to the HIV and pharmacy teams.
- Good adherence to medical appointments
- Using a mobile app and acceptance of the established process.
- Signed Informed Consent.
Exclusion Criteria:
- Acute disease or decompensated chronic diseases in the last 6 months.
- Any other condition that advises against out-of-hospital follow-up.
- Participants who are already using the locker system to pick up their medication.
- Pregnant Women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Medical care at the Hospital
Includes medical follow-up visits, collection of ARV and analytical tests, as per usual rutinary practice, in Hospital.
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Experimental: Medical care at Out-of-Hospital community center
Evaluates the benefits of implementing the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To evaluate and compare the benefits in terms of patients' satisfaction derived from decentralizing the patient care versus continuing with the usual follow-up.
Time Frame: week 24
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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.
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week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
Time Frame: week 24
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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".
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week 24
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To evaluate and compare patients' quality of life
Time Frame: week 24
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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).
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week 24
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To evaluate and compare patients' perception of illness severity.
Time Frame: week 24
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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.
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week 24
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To evaluate and compare expectations and satisfaction among health staff (a nurse and a physician) regarding the positive impact of decentralizing the patient care.
Time Frame: week 24
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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.
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week 24
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Distance to care facility (out-of-hospital facility or hospital)
Time Frame: 24 weeks
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To assess and compare the two-way total transportation distance (in km) to out-of-hospital facility and to the hospital at week 24 for a total of 3 study visits in the study period.
Distance data from a single transfer is requested at the baseline visit.
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24 weeks
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Time to care facility (out-of-hospital facility or hospital)
Time Frame: 24 weeks
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To assess and compare the two-way total transportation time (in minutes) to the out-of-hospital facility and to the hospital at week 24 for a total of 3 study visits in the study period.
Time data from a single transfer is requested at the baseline visit.
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24 weeks
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Carbon footprint associated with healthcare visits
Time Frame: week 24
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Comparison of the estimated carbon footprint (in gCO2) generated by healthcare visits up to Week 24 between participants attending the out-of-hospital facility and those attending the hospital at week 24 for a total of 3 study visits in the study period.
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week 24
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OOH Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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