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

NCT07792070 | Completed DMC

• 1 other identifier: OOH Study
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HIV; HIV Antiretroviral Therapy (ART) Adherence; Health Care Delivery

Keywords

HIV; Patient Care Management; Decentralization; Carbon Footprint

Outcome Measures

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.

  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

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

  week 24

• 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

Other Outcomes (3)

• 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

Study Arms (2)

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.

Other: Implemention of the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point.

Interventions

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.

Medical care at Out-of-Hospital community center

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BCN Checkpoint: collaborator
• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead

Study Sites (1)

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 28, 2026
• Study Start: November 7, 2024
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)