Status:
COMPLETED
Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (SIMPLIFIED)
Lead Sponsor:
Fundacion SEIMC-GESIDA
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 Bictegr...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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...)
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05405751
Start Date
July 4 2022
End Date
June 12 2024
Last Update
June 28 2024
Active Locations (1)
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1
H. Infanta Leonor
Madrid, Spain