Remote app-based counseling for people with HIV who have anxiety or depression
Adaptation and Implementation of a Behavioral mHealth Intervention to Reduce Anxiety and Depression and End the HIV Epidemic in the Rural South
This project will test whether weekly video counseling delivered by community health workers through an app can reduce anxiety and depression in people living with HIV in Florida.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT07112001 on ClinicalTrials.gov |
What this trial studies
Investigators will run a pilot randomized controlled trial comparing an adapted mHealth app that adds community health worker (CHW)-delivered positive affect counseling to the standard app. Participants will be randomized to receive approximately five weekly 60-minute individual counseling sessions by secure video plus enhanced app resources or to the unmodified app representing standard mental health care. If a participant does not show symptomatic improvement, the CHW will refer them to a licensed mental health professional, and the team will continue to collect EMR and app data for about six months. Primary outcomes are changes in anxiety and depression symptoms measured with validated scales (GAD-7 and PHQ-8).
Who should consider this trial
Good fit: Ideal candidates are adults living with HIV in Florida who have at least mild anxiety (GAD-7 ≥ 5) and mild depression (PHQ-8 ≥ 5) and do not have active psychosis or current suicidal ideation.
Not a fit: Patients with active psychosis, current suicidal ideation, or those who require more intensive psychiatric care or cannot use private video calls are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could expand access to brief, remote mental health support and reduce anxiety and depression among people living with HIV.
How similar studies have performed: Related CHW-delivered and positive-affect mHealth interventions have shown promising results in small pilot studies, but robust evidence in people living with HIV is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Preeti Manavalan, MD
- Email: preeti.manavalan@medicine.ufl.edu
- Phone: 352-294-5480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.