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Quick HIV meds may slash stigma for drug users

NCT ID NCT06541028

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests whether starting antiretroviral therapy within 7 days of an HIV diagnosis can reduce stigma and improve health outcomes for people who inject drugs. Researchers will develop a rapid-start strategy and pilot it with 135 participants at HIV clinics. The goal is to lower stigma and viral load, making it easier for this group to stay healthy.

What this could mean

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

Active substance
rapid-start antiretroviral therapy (ART) within 7 days of diagnosis
What this could lead to
If successful, this could show that starting HIV treatment quickly after diagnosis reduces stigma and improves viral suppression in people who inject drugs.
What could go wrong
This is a small pilot study (135 participants) testing a behavioral strategy, not a new drug. Results may not apply to all clinics or populations, and stigma is complex to change.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

May 2028

An estimate. End dates often move.

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: PWID in general population: * Be a PWID from the general population enrolling into ART services at one of the study's HIV clinics. PWID can include patients injecting opioids, amphetamines, or other combinations of injectable drugs. Some of these patients may be diagnosed with Opioid Use Disorder (OUD). * Provide informed consent. * HIV clinicians prescribing ART 1. Be the HIV clinician who prescribes ART for a PWID in one of the selected clinics. 2. Be willing to use the RS-ART protocol. 3. Be at least 18 years old. No minors below age 18 will be enrolled in the study. 4. Provide informed consent. PWID in prison population: * Be a PWID enrolling into ART services at Kajang prison. PWID can include patients injecting opioids, amphetamines, or other combinations of injectable drugs. Some of these patients may be diagnosed with Opioid Use Disorder (OUD). * Provide informed consent. Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease substance abuse

As listed by the trial registrant

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

Drug use HIV

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre of Excellence for Research in AIDS (CERiA) - University of Malaya

    ACTIVE_NOT_RECRUITING

    Kuala Lumpur, 50450, Malaysia

  • Kajang Prison

    RECRUITING

    Kajang, 43000, Malaysia

  • Primary Healthcare Centers

    RECRUITING

    Kuala Lumpur, 50450, Malaysia

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