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Fitbit and coaching may help HIV patients cut back on heavy drinking

NCT ID NCT05505942

Symptom relief Sponsor: Boston University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study tests whether a home-based physical activity program, using a Fitbit and coaching sessions, can help people with HIV who drink heavily increase their daily steps and reduce their alcohol intake. The trial involves 222 participants in the U.S. who are low-active and drink above healthy limits. Half receive coaching plus a Fitbit, the other half just a Fitbit, and progress is tracked at 3 and 6 months.

What this could mean

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

Active substance
lifestyle physical activity sessions and a Fitbit
What this could lead to
If it works, this could offer a simple, home-based way to help people with HIV who drink heavily become more active and reduce their drinking.
What could go wrong
This is a small, early-stage trial with only 222 participants, and the results may not apply to everyone. The intervention is behavioral, so success depends on individual motivation and adherence.

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

222 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Sep 2026

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: * Have the ability to confirm HIV diagnosis either through visual evidence of ART medication or medical record * Engaged in unhealthy drinking, defined as: \>7 drinks for women / \> 14 drinks for men per week OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month. * Have a smartphone * Considered low active: 150 minutes or less of average weekly physical activity * Lives in the USA * Has a U.S. mailing address Exclusion Criteria: * History of bipolar, schizophrenia, schizoaffective disorder or mania per self report. * History of withdrawal-related seizures or delirium tremens per self report. * Current non-pharmacological treatment for alcohol use disorder. * Unable to provide one or more individuals for follow up contact. * Current DSM-5 diagnosis of anorexia or bulimia nervosa per self report. * Marked organic impairment according to responses to the diagnostic assessments * Physical or medical problems that would not allow safe participation in a program of moderate intensity PA * Individual who is unwilling to provide their sex at birth * Limited or non-readers

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Conditions

The condition(s) this trial relates to.

alcohol abuse HIV infectious disease Sedentary Behavior

As listed by the trial registrant

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

HIV Physical inactivity Unhealthy alcohol use

Contacts and locations

Locations

  • Boston University, Department of Medicine, remote research

    Boston, Massachusetts, 02118, United States

More trials for these conditions

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