PositiveLinks with Counseling for Anxiety and Depression in People With HIV

Overseen By Preeti Manavalan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Active psychosis, Suicidal ideation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist people with HIV who also experience anxiety or depression. Researchers are evaluating the effectiveness of a modified app, PositiveLinks with Counseling, which includes video calls with a community health worker, in reducing these mental health issues. The study compares this to the standard version of the app, which provides feedback and local resources. Individuals diagnosed with HIV who frequently feel anxious or down and have scores indicating mild anxiety or depression may be suitable for this trial. As an unphased trial, this study presents a unique opportunity to contribute to innovative research that could enhance mental health support for people with HIV.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mental health counseling intervention is safe for people with HIV?

Research has shown that the PositiveLinks app, when combined with counseling, is generally easy to use. The app primarily helps people with HIV manage their health by providing support and resources. Studies have found that this method effectively reduces anxiety and depression without major side effects. Users have reported positive experiences, indicating its safety for those seeking mental health support alongside their HIV care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PositiveLinks with Counseling because it offers a unique approach to managing anxiety and depression in people with HIV. Unlike standard care options, which might involve separate counseling sessions and mental health resources, this treatment integrates positive affect counseling directly into the PositiveLinks app through video calls with community health workers. This innovative delivery method makes mental health support more accessible and immediate, potentially improving adherence and outcomes. Additionally, the app's modification allows for tailored interventions that are seamlessly integrated into the user's daily routine, offering a personalized and convenient solution.

What evidence suggests that PositiveLinks with Counseling is effective for reducing anxiety and depression in people with HIV?

Past research has shown that combining mental health counseling with HIV care reduces anxiety and depression in people living with HIV. In this trial, one group of participants will use a modified version of the PositiveLinks app. This version includes counseling delivered by community health workers via video call to promote positive feelings and support mental well-being. Studies have shown that patients using the PositiveLinks app, along with counseling, experience better mental health. This approach has proven effective and is expected to improve mental health by helping individuals feel more supported and connected. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with HIV in Florida who are experiencing anxiety and depression, as indicated by scores of 5 or more on the GAD-7 and PHQ-8 scales. It's not suitable for individuals with active psychosis or those having thoughts about suicide.

Inclusion Criteria

GAD-7 score of 5 or greater

PHQ-8 score of 5 or greater

I have been diagnosed with HIV.

Exclusion Criteria

Active psychosis

Suicidal ideation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CHW-delivered positive affect counseling via video call approximately weekly for 5 weeks

5 weeks

5 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment through data abstraction from EMR and mHealth app

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PositiveLinks with Counseling

Trial Overview The study is testing a mental health counseling intervention delivered remotely by community health workers using PositiveLinks, compared to the standard care that patients usually receive for their conditions.

How Is the Trial Designed?

Group I: Modified PositiveLinks app with CHW-delivered counseling Experimental Treatment 1 Intervention

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 II: Unmodified PositiveLinks with no counseling Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. withpower.com withpower.com/trial/phase-depression-6-2025-ebbd3

PositiveLinks with Counseling for Anxiety and Depression ... ... Counseling will have tolerable side effects & efficacy for patients with Anxiety Disorders, HIV/AIDS, Depression, Depression and Anxiety. See if you qualify

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10127013/

Mapping the effectiveness of integrating mental health in ... Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS) are major public health issues globally, with high mortality ...

3. researchgate.net researchgate.net/publication/380951171_Patient_Perspectives_on_Portal-Based_Anxiety_and_Depression_Screening_in_HIV_Care_A_Qualitative_Study_Using_the_Consolidated_Framework_for_Implementation_Research

(PDF) Patient Perspectives on Portal-Based Anxiety and ... The effect of antidepressant treatment on HIV and depression outcomes: Results from a randomized trial. AIDS 2015,29, 1975–1986. [CrossRef] [ ...

4. iapac.org iapac.org/files/2022/12/ADH-23-Poster-Abstracts-Book-06-06-23.pdf

This activity is supported by independent medical ... specific tailoring for SU, PositiveLinks facilitates good HIV outcomes ... human immunodeficiency virus (YLWH) face challenges in achieving viral ...

5. iapac.org iapac.org/AdherenceConference/assets/Adherence2017_Abstracts3.pdf

Adherence Conference 2017 Abstracts Methods: Data from 188 men and women living with HIV/AIDS in Miami,. FL ... human immunodeficiency virus (HIV) infection case rate and by year-end. 2014 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7071062/

Secure Messaging Through PositiveLinks: Examination ... Keywords: mobile health, smartphone app, HIV/AIDS, patient–provider communication, PositiveLinks, telemedicine ... HIV care and clinical outcomes with 12-month ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6446157/

Development of PositiveLinks: A Mobile Phone App to ... HIV care visits and time to viral suppression, 19 US jurisdictions, and implications for treatment, prevention and the national HIV/AIDS strategy. PLoS One ...

8. link.springer.com link.springer.com/article/10.1007/s10461-018-2174-6

A Mixed Methods Study of the PositiveLinks Mobile Health ... Developing a model for online support group use, empowering processes and psychosocial outcomes for individuals living with HIV/AIDS.

9. researchgate.net researchgate.net/publication/332244974_Original_Paper_Development_of_PositiveLinks_A_Mobile_Phone_App_to_Promote_Linkage_and_Retention_in_Care_for_People_With_HIV

(PDF) Original Paper Development of PositiveLinks ... outcomes with 12-month follow-up. AIDS Patient Care ... Objective Latinx people comprise 30% of all new human immunodeficiency virus (HIV) ...