Recruiting

Mental Health Counselling

Sponsor:

University of Florida

Code:

NCT07112001

Conditions

HIV

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PositiveLinks with Counseling

Standard of Care (SOC)

Study Details

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

Study ID

NCT07112001

Start date

Jul 31, 2025

Status verified date

Aug, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Active psychosis
  • Suicidal ideation

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

PositiveLinks with Counseling

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

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

Primary outcome measure

  • Reduction in Depression [ Time Frame: 3 months ]
  • Reduction in Anxiety [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Preeti Manavalan, MD

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

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32607

Contacts

Preeti Manavalan, MD

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

Principal Investigator:

Preeti Manavalan, MD

More Information

Sponsor

University of Florida

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Keywords

  • HIV
  • Depression
  • Anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-08-08.