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Can a phone app and a health worker ease depression in rural HIV care?

NCT ID NCT07112001

Symptom relief Sponsor: University of Florida 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are adapting a mobile health program that pairs the PositiveLinks app with video counseling from a community health worker. The study enrolls 60 people in Florida who have HIV and mild to moderate anxiety or depression. Participants receive either the enhanced counseling program or the standard app plus usual clinic care. The team measures changes in depression and anxiety using standard questionnaires.

What this could mean

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

Active substance
A community health worker-delivered counseling program through the PositiveLinks mobile app
What this could lead to
If it works, this could give people with HIV in rural areas a way to get mental health counseling from home, without traveling to a clinic.
What could go wrong
The study is small and early, so it may not show a clear benefit. Some people may find video counseling less helpful than in-person care, and the results may not apply to other regions.

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 60 people

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

Started

Jul 2025

Expected to finish

Nov 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 to 90 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: * HIV diagnosis * GAD-7 score of 5 or greater * PHQ-8 score of 5 or greater Exclusion Criteria: * Active psychosis * Suicidal ideation

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Depression depressive disorder HIV infectious disease

As listed by the trial registrant

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

Anxiety Depression HIV

Contacts and locations

Locations

  • University of Florida

    Gainesville, Florida, 32607, United States

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