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Completed

NCT Number: NCT07792070

Pilot Study to Evaluate the Decentralization of Patient Care Among People With HIV in Out-of-hospital Settings

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.

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Key information

Conditions

HIV HIV Antiretroviral Therapy (ART) Adherence Health Care Delivery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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".

  2. To evaluate and compare patients' quality of life

    Time frame: week 24

    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).

  3. To evaluate and compare patients' perception of illness severity.

    Time frame: week 24

    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.

  4. 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

    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.

Other outcomes

  1. Distance to care facility (out-of-hospital facility or hospital)

    Time frame: 24 weeks

    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.

  2. Time to care facility (out-of-hospital facility or hospital)

    Time frame: 24 weeks

    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.

  3. Carbon footprint associated with healthcare visits

    Time frame: week 24

    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.

Sponsors and collaborators

Lead sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Other

Collaborators

  • BCN Checkpoint

Registry information

Acronym: OOH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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