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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion SEIMC-GESIDA
• Treatments: Emtricitabine; Emtricitabine tenofovir alafenamide; Tenofovir

Criteria

Inclusion Criteria:

• Vulnerable person ≥18 years

• Understand and sign the informed consent form

• Confirmed HIV infection

• Not receiving ART or on ART with a PVL > copies/ml

Exclusion Criteria:

• Unable to provide contact details

• History of allergy to any of the following drugs: bictegravir, tenofovir alafenamide or emtricitabine

• Taking antiretroviral treatment for less than 1 month

• Pregnancy or breastfeeding at the time of screening or gestational desires during the study period.

• Suspected or diagnosed of active opportinistic disease

• History of severe liver disease (Child- Pugh C) or history of descompensated liver disease (defined as the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice)

• History of kidney disease CKP-EPI< 30ml/min

• Have any condition that, as per investigator criteria, makes the patient not candidate to be included (active disease, social situation, intoxication...)