Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 10:01 PM
Study NCT ID:
NCT05405751
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2022-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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)
Sponsor:
Fundacion SEIMC-GESIDA
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMPLIFIED
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: