NCT07112001 · University of Florida
A Behavioral mHealth Intervention for People With HIV With Anxiety and Depression
What this study is about
This study will adapt and assess the preliminary effectiveness of a community health worker-delivered mental health counselling intervention delivered remotely to reduce anxiety and depression among people with HIV in Florida.
View original scientific description
This study will adapt and assess the preliminary effectiveness of a community health worker-delivered mental health counselling intervention delivered remotely to reduce anxiety and depression among people with HIV in Florida.
Interventions
BEHAVIORAL
PositiveLinks with Counseling
A community health worker delivered, specialized counseling intervention through video call on the PositiveLinks app
BEHAVIORAL
Standard of Care (SOC)
This intervention includes the use of the unmodified PositiveLinks app and the standard of care for addressing anxiety and depression in the HIV clinic
Primary outcome measures
Reduction in Depression
Time frame: 3 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 Anxiety
Time frame: 3 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- HIV diagnosis
- GAD-7 score of 5 or greater
- PHQ-8 score of 5 or greater
Exclusion criteria
- Active psychosis
- Suicidal ideation
Where
- Gainesville, Florida
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 8, 2025 · Source of record for eligibility and locations