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-GESIDA

Status and phase: Completed; Phase 4

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05405751

GESIDA 12221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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...)

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Patients received BIKTARVY (BIC/FTC/TAF)

Experimental group

Description:

The patient enrolled in the study and access HIV consulting will start treatment with BIKTARVY the same day of the inclusion. The medication will provided by the sponsor and it will be dispensed by pharmacy service. The delivery of medication to the patient can be delegated by a member of investigator staff who pick up the mediaction from pharmacy service to be delivered to the patient. The patient can pick up the medication directly from the pharmacy service. It will be recorded the face to face on delegated dispensing. The deliver of medication will be bi-monthly and 2 bottles of tablets will be dispensed. The patients will receive a BIC/FTC/TAF single oral dose per day for 12 months.

Treatment:

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