HIV Suicide Prevention With AI-DBT

NCT07339189 | Recruiting DMC

• 2 other identifiers: PRO2024000600R34MH134693
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Suicidal Ideation and Behavior; HIV; AIDS (Acquired Immune Deficiency Syndrome)

Keywords

suicide; HIV; mHealth

Outcome Measures

Primary Outcomes (1)

• Self-efficacy to manage emotions

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

  baseline, 6 and 12 weeks for long-form.

Study Arms (2)

usual care

NO INTERVENTION

Usual care

AI-DBT

EXPERIMENTAL

AI-DBT group will receive 14 videos under 5 minutes across 7 weeks and the opportunity to engage in skills coaching with an AI chatbot

Behavioral: AI-DBT

Interventions

AI-DBT BEHAVIORAL

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.

AI-DBT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

New Jersey Community Research Initiative

Newark, New Jersey, 07103, United States

RECRUITING

RWJB Infectious Disease

Newark, New Jersey, 07112, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Behavior; Acquired Immunodeficiency Syndrome; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Elissa Kozlov, PhD

  Rutgers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jared Khan, MPH

CONTACT

2016672414; khanjj@sph.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 14, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)