NCT05405751

Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (SIMPLIFIED)

Simplified Model of Linkage and Retention to Healthcare System, Using a Mobil Unit and a Same-day Test and Treat Approach Among Excluded Population.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Fundacion SEIMC-GESIDA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Implementation of a model for access and retention of HIV care for vulnerable and excluded population using a mobile screening unit and a strategy of diagnosis and initiation of treatment with Bictegravir (BIC) 50 mg/ Emtricitabine (FTC) 200 mg / Tenofovir Alafenamide (TAF) 25 mg.

Detailed description

The use of a mobile unit to reach vulnerable HIV-infected people with poor access to the health care system and starting/restarting on the same day ("simplified same day test and treat strategy") is feasible, effective and safe and will allow these people to have a rapid access to ART and long-term follow-up and health care for HIV. At the screening visit the patient will sign the informed consent form, revise the clinical history and ensure compliance with criteria. A history of drug abuse, complete physical examination, pregnancy test, rapid hepatitis C test, questionnaires and social situation will be collected from the patient. At the basal visit the patients enrolled in the study will collect lab test (blood count, biochemistry, coagulation, serology, inmunology and virology), vital signs and directed physical examination, concomitant medication and adverse events. After the basal visit the patient will be followed up on visits week 4, 12, 24, 48 and last visit 50 as follow up safety visit.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]	Patients enrolled in the study and accessing the HIV consultation will start treatment with BIKTARVY on the day of enrollment. Medication will be provided by the sponsor and dispensed through the pharmacy service. The drug will be delivered to the patient with a delegated person outside the hospital environment or it will be the patient himself who picks up the medication.

Timeline

• Start date: 2022-07-04
• Primary completion: 2023-12-26
• Completion: 2024-06-12
• First posted: 2022-06-06
• Last updated: 2024-06-28

Locations

1 site across 1 country: Spain