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Phone therapy aims to boost brain health in older HIV patients

NCT ID NCT07272863

Symptom relief Sponsor: University of Alabama, Tuscaloosa 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a short, telephone-delivered insomnia treatment (BBTI) can improve sleep and cognitive function in 214 older adults with HIV, compared to a mindfulness approach (BMT). Participants will complete four weekly phone sessions and attend in-person visits for sleep and thinking tests over one year. The goal is to find a practical way to support brain health in this aging population.

What this could mean

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

Active substance
Brief Behavioral Treatment for Insomnia (BBTI) and Brief Mindfulness Treatment (BMT), both delivered via telephone
What this could lead to
If successful, this could offer a simple, phone-based way to improve sleep and thinking in older adults with HIV, potentially reducing dementia risk.
What could go wrong
This is an early-stage study with no results yet. The benefits may be small or not last long, and the findings may not apply to everyone with HIV.

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 214 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

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

50 to 99 years

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: * must be age 50 or older * have a DSM-5 diagnostic criteria for insomnia including sleep difficulty that occurs at least 3 times per week and has been a problem for at least 3 consecutive months (indicated on the Structured Clinical Interview for Sleep Disorders, SCISD) during telephone screening * have a confirmed HIV diagnosis and a prescribed ART regimen for at least 12 months. Exclusion Criteria: * unable to speak English * have a reported or documented (in medical records) diagnosis of AD or dementia * have severe neurocognitive impairment (\>7 errors on the Short Portable Mental Status Questionnaire, SPMSQ) during telephone screening * have a history of a stroke * currently undergoing radiation/chemotherapy * reports a history of brain trauma with loss of consciousness greater than 30 minutes * have a learning disability * have a documented diagnosis of sleep apnea (in medical records) * reports use of a continuous positive airway pressure machine * have been identified as high risk for moderate to severe sleep apnea (Snoring, Tiredness, Observed sleep apnea, Pressure, BMI, Age, Neck circumference, and Gender, STOP BANG ≥ 5) during telephone screening * have restless leg syndrome and/or have narcolepsy * have a documented history of bipolar disorder or psychotic disorder * not be receiving efavirenz as part of their current ART regimen

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Conditions

The condition(s) this trial relates to.

Alzheimer disease HIV infectious disease insomnia

As listed by the trial registrant

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

Aging Cognition HIV Insomnia

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

  • The University of Alabama

    Tuscaloosa, Alabama, 35401, United States

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

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