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

NCT ID: NCT07112001

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-11-30

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.

Detailed Description

The investigators will conduct a pilot randomized controlled trial to evaluate the preliminary effectiveness of an adapted community health worker (CWH)-delivered positive affect counselling intervention delivered remotely via mHealth. The adapted intervention will include CHW-delivered positive affect skill-based counseling accessible through video call that will be accessible through the mHealth app. The CHW will conduct approximately 5 weekly individual 60-minute counseling sessions via a secure video call feature. If the participant does not have symptomatic improvement, the CHW will refer the participant to a licensed mental health professional. Participants will be randomized to receive access to the counselling intervention that also includes modified features of the mHealth app with increased mental health resources (intervention arm) or to current standard of mental health care that includes the unmodified version of the app (control arm). Participants allocated to the intervention arm will receive the counseling intervention approximately weekly for 5 weeks. The study will continue to abstract data from participants' EMR and mHealth app for approximately 6 months after enrollment. To assess preliminary effectiveness, the investigators will analyze differences by condition in anxiety and depression (primary outcome). Informed consent will be obtained prior to study participation.

Conditions

HIV; Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

PositiveLinks with Counseling

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: 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

Interventions

PositiveLinks with Counseling

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Preeti Manavalan, MD

Role: CONTACT

preeti.manavalan@medicine.ufl.edu

352-294-5480

Facility Contacts

Preeti Manavalan, MD

Role: primary

preeti.manavalan@medicine.ufl.edu

352-294-5480

Other Identifiers

K23MH131463

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202003223

Identifier Type: -

Identifier Source: org_study_id