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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07112001
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • PositiveLinks with Counseling — BEHAVIORAL
    A community health worker delivered, specialized counseling intervention through video call on the PositiveLinks app
  • Standard of Care (SOC) — BEHAVIORAL
    This intervention includes the use of the unmodified PositiveLinks app and the standard of care for addressing anxiety and depression in the HIV clinic

Study Details

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.

Key Dates

Start date
Jul 31, 2025
Status verified
Aug 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Modified PositiveLinks app with CHW-delivered counseling
    This arm includes a modified version of the PositiveLinks app which includes access to community health worker-delivered positive affect counseling via a video call feature on the app
  • Active Comparator: Unmodified PositiveLinks with no counseling
    This arm includes the standard of care which includes the standard version of the PositiveLinks app and feedback on self-reported anxiety and depression symptoms and a list of local mental health resources

Primary Outcome Measure

Reduction in Depression [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32607
Preeti Manavalan, MD
[email protected]
352-294-5480
Preeti Manavalan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By condition
DepressionHIV
By specialty
PsychiatryMental healthBehavioral healthInfectious disease
By research site
University of Florida· Gainesville, FL

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