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Suicidal Ideation and BehaviorNCT07339189

HIV Suicide Prevention With AI-DBT

A study testing AI-DBT in people with Suicidal Ideation and Behavior and HIV, run by Rutgers, The State University of New Jersey at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
AI-DBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesUnited States
Study dates
7 Jan 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 50+
  • evidence of suicide risk as defined by at least one of the following: PHQ-9 suicide item > 0, Ask Suicide Questions (ASQ, an NIMH-supported suicide risk screener with a version tailored for primary care) > 0, expression of suicidal thoughts to the provider during appointment, a suicide attempt in the past year, or PHQ-9 total score ≥ 8,
  • ability to read and communicate fluently in English or Spanish
  • not at imminent risk for suicide (does not have significant intent to die within 48 hours)
  • has a smartphone capable of texting and accessing the internet.

Who cannot join

  • deemed clinically inappropriate to participate because of severe psychosis, severe substance use, or severe cognitive deficits that would interfere with their comprehending study and intervention material.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jared Khan, MPH contact

2016672414

khanjj@sph.rutgers.edu

United States2 sites, 2 recruiting
  • New Jersey Community Research Initiative

    Newark, New Jersey, 07103

    Recruiting
  • RWJB Infectious Disease

    Newark, New Jersey, 07112

    Jared Khan, MPH, khanjj@sph.rutgers.edu

    Not yet recruiting

Other trials in United States

About this study

Official title: Piloting AI-Delivered Dialectical Behavioral Therapy for Suicide Prevention in Older Patients Living With HIV

One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, investigators will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, Empower Health. Investigators will then pilot test the feasibility, usability, acceptability and preliminary efficacy to improve self-efficacy to manage negative emotions in n=50 older adults living with HIV/AIDS.

Read the detailed description

One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk of death by suicide is 100 times higher in PLWHA than in the general population. In the United States, there are approximately 1.2 million PLWHA, and 35% are adults aged 55 and over. Older PLWHA experience unique combinations of stressors including externalized and internalized stigma from advanced age and disease status. Despite the increased risk and unique risk factors older PLWHA have for suicide mortality, there have been no interventions developed specifically for this population to address suicide risk. Dialectical Behavioral Therapy (DBT) shows significant impact at reducing suicidal behaviors by improving one's self-efficacy to manage negative emotions. DBT has never been evaluated with PLWHA for suicide prevention, representing a critical gap in the science. Innovative solutions to mental health care, such as AI-powered chatbots, have also not been studied extensively in older PLWHA. The objective of this R34 Intervention Development and Pilot grant proposal is to adapt DBT Skills and Coaching for suicide prevention in older PLWHA to be delivered via brief videos and Angel. Angel is an artificial intelligence (AI)-powered conversational agent developed by CareAngel, a company that leverages cutting edge AI and natural language processing technology. Investigators plan to adapt existing evidence-based DBT skills videos and add coaching support from Angel in a 6-week intervention with older PLWHA. This proposal has the following specific aims: Phase 1: Adaptation: Aim 1) To adapt DBT Skills and Coaching for PLWHA seeking care in infectious disease practices to be delivered via Angel. Phase 2: Pilot feasibility and preliminary efficacy RCT with n=50 PLWHA: Aim 2) To establish the feasibility, acceptability, and usability of the adapted DBT Skills and Coaching intervention through key metrics of use, survey item responses, and qualitative interviews surrounding barriers and facilitators to use with patients enrolled in the intervention. Aim 3) To explore the preliminary efficacy, relative to usual care control, of DBT skills videos and Angel-delivered DBT Coaching on the target mechanism, self-efficacy to manage negative emotions, as well as exploratory clinical outcomes including suicide outcomes, mood, and medical treatment adherence. This proposed work is of high scientific and public health significance for numerous reasons: 1.) older PLWHA have elevated suicide risk. 2.) there is a paucity of suicide prevention intervention research for PLWHA. 3.) while Dialectical Behavioral Therapy has been studied in over 30 randomized controlled trials with demonstrated efficacy to improve psychological outcomes in diverse populations, to our knowledge, this intervention has never been piloted with older PLWHA. 4.) Innovative solutions to mental health care, such as AI-powered chatbots + videos, have not been studied in older PLWHA, thus this proposal represents an exciting opportunity to fill critical gaps in the literature on potentially scalable, implementable, and effective approaches to suicide prevention in PLWHA.

Being tested
AI-DBT
Keywords
suicide, HIV, mHealth
Medical subject headings
Suicidal Ideation, Behavior, Acquired Immunodeficiency Syndrome, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-DBTBehavioural

    Participants will receive 14, 5 minute videos delivered 2x/week that describe DBT skills and tools. They will also receive the option of engaging in coaching sessions.

Study groups in NCT07339189
Study groupRoleWhat they receive
usual careNo interventionUsual care
AI-DBTExperimentalAI-DBT group will receive 14 videos under 5 minutes across 7 weeks and the opportunity to engage in skills coaching with an AI chatbot
Receives: Behavioral: AI-DBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-efficacy to manage emotions

    Scale to determine if someone has self-efficacy to manage negative emotions

    Measured: baseline, 6 and 12 weeks for long-form.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start7 Jan 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07339189
Sponsor's protocol ID
PRO2024000600
Other IDs
R34MH134693
Status last verified
Jan 2026
First submitted
12 Jan 2026
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The plan is to share data with the NIMH NDA repository.

Questions about this trial

What is this clinical trial studying?

A study testing AI-DBT in people with Suicidal Ideation and Behavior and HIV, run by Rutgers, The State University of New Jersey at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jared Khan, MPH (2016672414, khanjj@sph.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-efficacy to manage emotions (time frame: baseline, 6 and 12 weeks for long-form.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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