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 | Completed Phase 4

• 1 other identifier: GESIDA 12221
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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 agreeing to participate in the study, proportion of subjects starting ART after inclusion, median time from the study inclusion to ART starting, proportion of subjects with HIV-1 RNA \<50 copies/mL at 24 weeks after inclusion, absolute values and changes from baseline in CD4+ cell count and CD4:CD8 at 24 weeks and proportion of subjects making visits at weeks 24 and 48 will be the endponts to measure the effectiveness of the strategy. The effectiveness threshold defined is: \>80% of enrolled subjects have plasma HIV-1 RNA \<50 copies/mL at 24 weeks post-inclusion and who are on follow-up and on ART at remain on follow-up and on ART at week 48. Incidence and severity of adverse events (clinical and laboratory) up to 24 weeks, incidence of adverse events leading to discontinuation of treatment up to week 24 and incidence of genotypic resistance mutations in participants with virological failure will be the endpoints to measure the safety of the strategy.

  24-48 weeks

Secondary Outcomes (1)

• To assess the implementation and feasibility of the intervention

  24-48 weeks

Study Arms (1)

Patients received BIKTARVY (BIC/FTC/TAF)

EXPERIMENTAL

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.

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

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.

Patients received BIKTARVY (BIC/FTC/TAF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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...)

Sponsors & Collaborators

• Fundacion SEIMC-GESIDA: lead

Study Sites (1)

H. Infanta Leonor

Madrid, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

bictegravir; Emtricitabine; tenofovir alafenamide; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, prospective, single-centre, single-arm, single-treatment study.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: June 6, 2022
• Study Start: July 4, 2022
• Primary Completion: December 26, 2023
• Study Completion: June 12, 2024
• Last Updated: June 28, 2024

Record last verified: 2023-07

Locations

ES (1)