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Mobile clinic brings HIV treatment to the streets: Same-Day start could transform care for the excluded

NCT ID NCT05405751

Disease control Sponsor: Fundacion SEIMC-GESIDA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests a new way to help vulnerable people with HIV get diagnosed and start treatment right away using a mobile screening unit. Participants receive the once-daily pill Biktarvy on the same day they are enrolled. The goal is to see if this approach helps them stay in care and keep the virus under control over 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy)
What this could lead to
If effective, this approach could help hard-to-reach groups get HIV under control quickly and stay in care, reducing transmission and improving health outcomes.
What could go wrong
This is a small, single-group study without a comparison group, so results may not apply broadly. Side effects from the medication or challenges in keeping participants engaged could limit success.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

101 people

The number who actually took part.

Started

Jul 2022

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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...)

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • H. Infanta Leonor

    Madrid, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.