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Telehealth program aims to get HIV treatment to people who inject drugs faster

NCT ID NCT05208697

Disease control Sponsor: University of Miami 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This study tested two ways to offer HIV treatment, hepatitis C treatment, and substance use disorder medications to people who inject drugs. One group received a telehealth-enhanced program with on-demand services like mobile blood draws and counseling, while the other group got standard care. The goal was to see if the telehealth approach helped more people get their HIV under control and cure hepatitis C.

What this could mean

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

Active substance
telehealth-enhanced harm reduction program
What this could lead to
If successful, this approach could make it easier for people who inject drugs to get HIV under control and treat hepatitis C at the same time.
What could go wrong
This was a small study (100 people) and the results may not apply to everyone. The program relies on telehealth and on-site services, which may not be available everywhere.

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

100 people

The number who actually took part.

Started

Oct 2022

Finished

Apr 2026

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: * age 18 or older * able to speak English * enrolled in IDEA Miami or IDEA Tampa SSPs * injection drug use in past 12 months by self-report * willing and able to sign informed consent, provide locator information and medical records release * testing reactive for HIV by rapid test * HIV RNA\>200 copies/ml as determined by on-site labs or abstracted medical records (result within 3 months of randomization date) Exclusion Criteria: * testing HIV negative via rapid test * receipt of THR intervention in the past 6 months * inability to provide informed consent * planning to leave the area within 12 months * Principal or site investigator discretion * currently in prison or jail * Enrollment in Clinical Trials Network 121

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Conditions

The condition(s) this trial relates to.

hepatitis C virus infection HIV infectious disease

As listed by the trial registrant

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

Hepatitis C HIV infections Iv drug usage

Contacts and locations

Locations

  • Care Resource The SPOT

    Fort Lauderdale, Florida, 33311, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

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