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

NCT05405751

CompletedPhase 4

Sponsor: Fundacion SEIMC-GESIDA

Conditions: HIV Infections

Interventions: Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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...)

Locations (1)

Madrid, Spain