Clinical trial NCT05405751: Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot, prospective, single-centre, single-arm, single-treatment study.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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...)

Primary outcomes:
measure: 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.
timeFrame: 24-48 weeks
Secondary outcomes:
measure: To assess the implementation and feasibility of the intervention
timeFrame: 24-48 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: H. Infanta Leonor
Study officials:
References: