Actively Recruiting
Adaptation and Implementation of a Behavioral mHealth Intervention to Reduce Anxiety and Depression and End the HIV Epidemic in the Rural South
Led by University of Florida · Updated on 2025-08-08
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a community health worker-delivered mental health counseling intervention delivered remotely via a mobile health app to reduce anxiety and depression among people living with HIV in Florida. This pilot randomized controlled trial aims to assess the preliminary effectiveness of this adapted positive affect counseling approach compared to the standard version of the app and usual mental health care. The study is sponsored by the University of Florida and focuses on improving mental health outcomes in this population. Participants will be randomly assigned to one of two groups. The intervention group will receive approximately five weekly 60-minute individual counseling sessions via secure video calls through a modified PositiveLinks app that includes enhanced mental health resources. If symptoms do not improve, participants may be referred to a licensed mental health professional. The control group will use the standard PositiveLinks app, which provides feedback on anxiety and depression symptoms and a list of local mental health resources without counseling. During the study, data will be collected from participants' electronic medical records and the app for about six months after enrollment. Researchers will measure changes in anxiety and depression levels at three months as primary outcomes. Participants will provide informed consent before joining, and there is no masking or blinding in the trial. The study will monitor mental health symptoms and the use of counseling through app data and medical records to evaluate the intervention's preliminary effectiveness.
CONDITIONS
Brief Title
A Behavioral mHealth Intervention for People With HIV With Anxiety and Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV diagnosis
- GAD-7 score of 5 or greater
- PHQ-8 score of 5 or greater
- Age between 18 and 90 years
You will not qualify if you...
- Active psychosis
- Suicidal ideation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for consent and eligibility assessment
Duration - Approximately 5 weeks
Participants in the intervention arm receive community health worker-delivered positive affect counseling sessions via video calls through the mHealth app.
Weekly video call counseling sessions for up to 5 weeks
Duration - Approximately 6 months after enrollment
Participants' electronic medical records and app data are monitored to assess anxiety and depression outcomes after counseling or standard care.
Data collection from medical records and app usage without additional visits
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32607
Actively Recruiting
Research Team
P
Preeti Manavalan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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