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

NCT ID: NCT05405751

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-04
• Study Completion Date: 2024-06-12

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 Bictegravir (BIC) 50 mg/ Emtricitabine (FTC) 200 mg / Tenofovir Alafenamide (TAF) 25 mg.

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 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.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patients received BIKTARVY (BIC/FTC/TAF)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DRUG

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...)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion SEIMC-GESIDA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

H. Infanta Leonor

Madrid, , Spain

Countries

Spain

Other Identifiers

GESIDA 12221

Identifier Type: -

Identifier Source: org_study_id