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

Fundacion SEIMC-GESIDA101 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

101

Conditions

HIV Infections

Interventions

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

H. Infanta Leonor

Madrid, Spain

Outcomes

Primary Outcomes

To Find Out Whether the Implementation of a Model of Access and Retention in Care for HIV Among Vulnerable People Using a Mobile Screening Unit and a Same-day Diagnosis and Treatment Initiation Strategy is Effective and Safety.

Proportion of subjects making visits at weeks 24 and 48.

Time frame: 24-48 weeks

Secondary Outcomes

To Assess the Implementation and Feasibility of the Intervention

Proportion of participants with HIV viral load \<50 copies/ml throughout the study

Time frame: Baseline, week 4, week 12, week 24 and week 48

Data from ClinicalTrials.gov

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