Pilot Study to Evaluate the Decentralization of Patient Care Among People With HIV in Out-of-hospital Settings
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.
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.
Inclusion Criteria:
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.
Signed Informed Consent.
Exclusion Criteria: