NCT07339189 · Rutgers, The State University of New Jersey
HIV Suicide Prevention With AI-DBT
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
AI-DBT
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.
Primary outcome measures
Self-efficacy to manage emotions
Time frame: baseline, 6 and 12 weeks for long-form.
Scale to determine if someone has self-efficacy to manage negative emotions
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Newark, New Jersey
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 15, 2026 · Source of record for eligibility and locations