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Smart pill bottles and health coaches team up to tackle HIV in the deep south

NCT ID NCT06472206

Disease control Sponsor: Columbia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether combining community health worker support with a smart pill bottle that tracks medication and sends reminders can improve HIV treatment adherence and viral suppression. The study enrolls 420 adults with HIV in Alabama, Louisiana, and Mississippi who have detectable virus levels. Participants receive either standard care or the CHAMPS+ intervention, which includes counseling and the CleverCap device.

What this could mean

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

Active substance
Community health worker sessions and a smart pill bottle (CleverCap) that tracks medication and sends reminders
What this could lead to
If effective, this approach could help more people with HIV achieve viral suppression and reduce transmission in underserved regions.
What could go wrong
The trial is relatively small and focused on three states, so results may not apply broadly. The intervention relies on smartphone ownership and consistent engagement.

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 420 people

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

Started

Sep 2024

Expected to finish

Dec 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

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: * Be able to speak, read, and write in English; * Be above 18 years of age; * Be willing to participate in any assigned arm of the intervention; * Have an HIV-1 RNA level \>200 copies/mL; * Own a smartphone; * Be able and willing to provide informed consent for study participation and consent for access to medical records. * Live, work and or receive care in AL, LA, or MS Exclusion Criteria: * Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment; * Terminal illness with life expectancy \<6 months; and * Planning to move out of the area in the next 12 months.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

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

HIV/AIDS

How to take part

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

  1. The places running it

    5 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

  • Health Services Center, Inc.

    RECRUITING

    Hobson City, Alabama, 36202, United States

  • Louisiana State University Health Sciences Center in New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Tulane University

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Unity Wellness Center

    RECRUITING

    Opelika, Alabama, 36801, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

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