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NCT Number: NCT07112001

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32607, United States

Location status: Recruiting

Location contact

Preeti Manavalan, MD

CONTACT

[email protected]

352-294-5480

Preeti Manavalan, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Active psychosis
  • Suicidal ideation

Treatment and study plan

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

Primary outcomes

  1. Reduction in Depression

    Time frame: 3 months

    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.

  2. Reduction in Anxiety

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Preeti Manavalan, MD

CONTACT

[email protected]

352-294-5480

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Adaptation and Implementation of a Behavioral mHealth Intervention to Reduce Anxiety and Depression and End the HIV Epidemic in the Rural South

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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