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

NCT07792070

CompletedNA

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

Conditions: HIV, HIV Antiretroviral Therapy (ART) Adherence, Health Care Delivery

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

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Badalona, Barcelona, Spain