Behavioral mHealth Intervention for HIV with Anxiety and Depression

This study is testing a specialized counseling program called PositiveLinks with Counseling for people with HIV who also experience anxiety and depression. This program uses video calls with a community health worker through the PositiveLinks app. The study will compare this new approach to the standard care, which uses the unmodified PositiveLinks app and usual clinic care for anxiety and depression. To join, you must be 18 to 90 years old, have an HIV diagnosis, and have certain scores on anxiety (GAD-7) and depression (PHQ-8) questionnaires. The main goal is to see if PositiveLinks with Counseling can reduce anxiety and depression after 3 months. The study is currently recruiting about 60 participants.

Study design
This is a pilot randomized controlled trial, meaning participants will be randomly assigned to one of two groups. Approximately 60 people will participate.
What's involved
If you are in the intervention group, you will have about five weekly 60-minute counseling sessions via video call. Data will be collected from your electronic medical records and the mHealth app.
Compensation
Not stated in the trial record.
Follow-up
Data will be collected from participants' electronic medical records and mHealth app for approximately 6 months after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07112001

A Behavioral mHealth Intervention for People With HIV With Anxiety and Depression

Active, Not Recruiting
NAAges 18–90InterventionalSupportive care
University of Florida
~60 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:PositiveLinks with CounselingStandard of Care (SOC)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction in Depression
Measured over 3 months
+1 more outcome measured
HIV
Depression
Anxiety

NCT07112001

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Florida

    Gainesville, Floridano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

HIV diagnosis
GAD-7 score of 5 or greater
PHQ-8 score of 5 or greater

Exclusion

Active psychosis
Suicidal ideation
  • Reduction in Depression3 months

    The intervention aims to reduce depression. This will be assessed using the Patient Health Questionnaire-8 (PHQ-8). The minimum score is 0. The maximum score is 24. A higher score indicates a worse outcome.

  • Reduction in Anxiety3 months

    The intervention aims to reduce anxiety. This will be assessed using the Generalized Anxiety Disorder-7 (GAD-7). The minimum score is 0. The maximum score is 21. A higher score indicates a worse outcome.