Back to resultsSimplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (SIMPLIFIED) (SIMPLIFIED)
Primary Purpose
HIV Infections
Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]
Sponsored by
About this trial
This is an interventional health services research trial for HIV Infections
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...)
Sites / Locations
- H. Infanta LeonorRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients received BIKTARVY (BIC/FTC/TAF)
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To assess the implementation and feasibility of the intervention
The evaluation of acceptability, comfort, suitability, usefulness, appropriateness, quality, perceived benefit and satisfaction with the perceived benefit and satisfaction of the intervention at the baseline visit and at the week 24 visit. These parameters will be collected using a scale of 0 to 5 and will be used to measure and assess the implementation of the strategy.
In addittion to assess the implementation of this project it will be used the endpoints referred to above (Evaluate the effectiveness of the strategy and evaluate the security of the strategy). The time frame for evaluate the effectivebes of the strategy and evaluate the security of the strategy are betwen 24 and 48 weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05405751
Brief Title
Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (SIMPLIFIED)
Acronym
SIMPLIFIED
Official Title
Simplified Model of Linkage and Retention to Healthcare System, Using a Mobil Unit and a Same-day Test and Treat Approach Among Excluded Population.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion SEIMC-GESIDA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Pilot, prospective, single-centre, single-arm, single-treatment study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients received BIKTARVY (BIC/FTC/TAF)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
24-48 weeks
Secondary Outcome Measure Information:
Title
To assess the implementation and feasibility of the intervention
Description
The evaluation of acceptability, comfort, suitability, usefulness, appropriateness, quality, perceived benefit and satisfaction with the perceived benefit and satisfaction of the intervention at the baseline visit and at the week 24 visit. These parameters will be collected using a scale of 0 to 5 and will be used to measure and assess the implementation of the strategy.
In addittion to assess the implementation of this project it will be used the endpoints referred to above (Evaluate the effectiveness of the strategy and evaluate the security of the strategy). The time frame for evaluate the effectivebes of the strategy and evaluate the security of the strategy are betwen 24 and 48 weeks.
Time Frame
24-48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta de Miguel
Phone
0034 915568025
Email
mdemiguel@f-sg.org
First Name & Middle Initial & Last Name or Official Title & Degree
Herminia Esteban
Phone
0034 915568025
Email
hesteban@f-sg.org
Facility Information:
Facility Name
H. Infanta Leonor
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Ryan, MD
12. IPD Sharing Statement
Learn more about this trial
Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (SIMPLIFIED)
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