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Smart pillbox sends alerts to keep HIV treatment on track

NCT ID NCT06550804

Disease control Sponsor: University of Illinois at Chicago 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests a smart pillbox that sends text alerts when a person misses their HIV medication. The alerts go to the user, a support person, and a case manager to help them get back on track. The study involves African American men who have sex with men and have trouble sticking to their antiretroviral therapy. The goal is to see if this approach is acceptable and feasible, and whether it improves medication adherence and viral suppression.

What this could mean

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

Active substance
A behavioral intervention using an electronic pillbox (Wisepill) that sends text alerts to the user, a support person, and a case manager when doses are missed.
What this could lead to
If effective, this approach could help people with HIV stay on their medication, achieve viral suppression, and reduce the risk of transmitting the virus.
What could go wrong
This is a pilot trial with a small number of participants, so results may not apply broadly. The intervention depends on consistent phone use and may not work for everyone.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 126 people

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

Started

Oct 2024

Expected to finish

Mar 2027

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

Accepted

You do not need to have the condition being studied to take part.

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: Participant inclusion criteria: * AAMSM \>18 years with self-reported HIV infection; * own a working cell phone; * on ART for at least 6 months; * have a case manager willing to participate in the study (for the clinical trial); and * have suboptimal adherence - either have a detectable viral load in the past 6 months, self-reported \<90% adherence based on a 3-item measure or referral by their healthcare provider because of a recognized problem with ART adherence. For social support persons, participants will: * report that they have a self-described meaningful relationship with the participant; * be \>18 years of age; * own a working cell phone and; * be willing to provide support. For case managers, participants will have worked with clients with HIV at least 6 months prior to their participation in this study and own a working cell phone. Exclusion Criteria: * Not meeting the inclusion criteria * Not agreeing to informed consent concerning interactions with research team, data collection, and access to medical records. * Candidates must provide consent to obtain a copy of their viral load results during the 12 months before and following study onset to confirm eligibility and explore long-term follow-up of possible effect.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Medication Adherence

As listed by the trial registrant

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

Adherence, medication HIV infections

Contacts and locations

Locations

  • University of Illinois Chicago

    Chicago, Illinois, 60612, United States

More trials for these conditions

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