HIVOOHNCT07792070
Pilot Study to Evaluate the Decentralization of Patient Care Among People With HIV in Out-of-hospital Settings
A study testing Implemention of the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point. in people with HIV and HIV Antiretroviral Therapy (ART) Adherence, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Antiretroviral Therapy (ART) Adherence, Health Care Delivery
- What is being tested?
- Implemention of the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 7 Nov 2024to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
About this study
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.
Read the 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.
- Being tested
- Implemention of the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point.
- Keywords
- HIV, Patient Care Management, Decentralization, Carbon Footprint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implemention of the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical care at the Hospital | No intervention | Includes medical follow-up visits, collection of ARV and analytical tests, as per usual rutinary practice, in Hospital. |
| Medical care at Out-of-Hospital community center | Experimental | Evaluates the benefits of implementing the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point. Receives: Other: Implemention of the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 24
Secondary outcomes (4)
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".
Measured: 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).
Measured: 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.
Measured: 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.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start7 Nov 2024
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- BCN Checkpoint
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792070
- Sponsor's protocol ID
- OOH Study
- Acronym
- OOH
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Decentralization of Patient Care Among People With HIV in Out-of-hospital Settings
- ClinicalTrials.gov ID
- NCT07792070
- Acronym / sponsor ID
- OOH / OOH Study
- Keywords
- HIV, Patient Care Management, Decentralization, Carbon Footprint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- BCN Checkpoint
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical care at the Hospital | No intervention | –Includes medical follow-up visits, collection of ARV and analytical tests, as per usual rutinary practice, in Hospital. |
| Medical care at Out-of-Hospital community center | Experimental | Other: Implemention of the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point.Evaluates the benefits of implementing the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Stable ARV treatment for ≥6 months with oral medications including:
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implemention of 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. | Other | Medical care at Out-of-Hospital community center |
Primary outcome
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
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.
4 secondary outcomes
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
To evaluate and compare patients' quality of life
Time frame: week 24
To evaluate and compare patients' perception of illness severity.
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.
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implemention of the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point. in people with HIV and HIV Antiretroviral Therapy (ART) Adherence, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.