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

NCT07112001 | Recruiting

• 2 other identifiers: 202003223K23MH131463
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Depression; Anxiety

Keywords

HIV; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Reduction in Depression

  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.

  3 months

• Reduction in Anxiety

  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.

  3 months

Study Arms (2)

Modified PositiveLinks app with CHW-delivered counseling

EXPERIMENTAL

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

Behavioral: PositiveLinks with Counseling

Unmodified PositiveLinks with no counseling

ACTIVE COMPARATOR

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

Behavioral: Standard of Care (SOC)

Interventions

PositiveLinks with Counseling BEHAVIORAL

A community health worker delivered, specialized counseling intervention through video call on the PositiveLinks app

Modified PositiveLinks app with CHW-delivered counseling

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

Unmodified PositiveLinks with no counseling

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active psychosis
• Suicidal ideation

Sponsors & Collaborators

• University of Florida: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32607, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Counseling; Standard of Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Preeti Manavalan, MD

CONTACT

352-294-5480; preeti.manavalan@medicine.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 8, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)