IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania

IDEAS for Hope: A Brief Telehealth Intervention to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania

In this project, the investigators will conduct a clinical trial to test the effectiveness and implementation of IDEAS for Hope, a 3-session telehealth counseling intervention delivered by nurses, to reduce suicidality and improve HIV care engagement among PLWH in Tanzania. The investigators will also examine mechanisms of change and implementation outcomes of the intervention, including cost-effectiveness, to disseminate a feasible, scalable, and sustainable intervention and implementation package to address a critical mental health comorbidity in HIV care.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicide Prevention; HIV - Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: IDEAS for Hope; Behavioral: Safety Planning Intervention

Detailed Description

Suicide is a leading cause of death among people living with HIV (PLWH) worldwide and PLWH in Tanzania are two to three times as likely to die by suicide compared to people without HIV. Mental health challenges are also closely linked to poor HIV outcomes, including lapses in clinic attendance, poor medication adherence, risk of HIV transmission, and AIDS-related death. Yet when PLWH receive mental health treatment that addresses barriers to HIV treatment adherence, both mental health and HIV outcomes improve. The investigators are developing innovative approaches to bridge the mental health treatment gap in Tanzania, including telehealth and nurse-led counseling interventions. The investigators previously developed and conducted a pilot feasibility randomized controlled trial of IDEAS for Hope, a 3-session telehealth counseling intervention, led by nurses, to reduce suicide risk and improve HIV care engagement in Tanzania. The IDEAS for Hope intervention, grounded in Motivational Interviewing, CBT, and Problem-Solving Therapy frameworks, facilitates HIV education, stigma reduction, and social support to address social determinants of suicide risk. The pilot trial with 60 PLWH who were experiencing suicidal ideation demonstrated clear feasibility and acceptability of IDEAS for Hope, as well as strong trends toward intervention efficacy to reduce suicide risk. The long-term objective of this research is to develop a scalable implementation package to expand care, reduce suicide risk, and improve HIV care engagement in Tanzania. In Aim 1, the investigators will determine the effectiveness of IDEAS for Hope to reduce suicide risk and improve HIV care engagement in an individually randomized controlled trial. Based on the pilot trial, the investigators hypothesize that IDEAS for Hope will reduce suicidal plan and intent to near zero and will improve HIV care engagement by 17% at 6-month follow-up, which will be statistically superior to brief safety planning. In Aim 2, the investigators will explore mechanisms of change to identify how and for whom IDEAS for Hope is most effective. The investigators will analyze the effect of hypothesized mediators of suicide risk and HIV care engagement, including self-efficacy, depression, anxiety, and stigma; potential moderators include sex, age, and severity of baseline symptoms. These data will inform future refinement for at-risk groups and adaptation to other settings. In Aim 3, the investigators will evaluate implementation outcomes, including cost-effectiveness, guided by the Consolidated Framework for Implementation Research (CFIR). The investigators hypothesize that IDEAS for Hope will be effectively expanded to 12 clinic sites, with a favorable Incremental Cost-Effectiveness Ratio. Structured surveys and qualitative interviews with patients and providers will assess fidelity and sustainability outcomes for implementation. Given the emerging evidence for telehealth and nurse-led approaches, IDEAS for Hope has great potential to reduce the mental health treatment gap in Tanzania. The research is innovative, yet fundamentally essential, and supports NIH Strategic Objectives to prevent suicide across the lifespan in low- and middle-income countries, address mental health comorbidities of HIV, and strengthen the HIV care continuum.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brandon A Knettel, Ph.D.; Phone Number: (919) 660-1218; Email: brandon.knettel@duke.edu

Study Locations

• Tanzania
  • Moshi, Tanzania
    • Kilimanjaro Clinical Research Institute
    • Contact: Blandina Mmbaga, MD, MMED, PhD; Phone Number: +255 27 275 4201; Email: b.mmbaga@kcri.ac.tz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult
• Living with HIV
• Attending HIV care appointments
• Self-report experiencing thoughts of suicide in the last 30 days

Exclusion Criteria:

• Physically or cognitively unable to provide informed consent or complete study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDEAS for Hope; 3-session, nurse-delivered, telehealth counseling intervention developmed by Knettel and colleagues	Behavioral: IDEAS for Hope; The IDEAS for Hope framework integrates Joiner's Interpersonal Theory to address stigma, burdensomeness, and other drivers of suicide risk and improve HIV care engagement. This includes theoretical grounding in Motivational Interviewing-enhanced safety planning (MI-SafeCope), stigma reduction, cognitive-behavioral therapy with adherence counseling (CBT-AD), and problem-solving therapy. MI-SafeCope improves coping for suicide risk by developing an individualized safety plan and facilitating social support. The integration of MI into standard safety planning goes beyond identifying coping strategies to facilitate values-driven improvement in health behavior and address the unique drivers of suicide risk among PLWH in Tanzania.
Active Comparator: Brief Safety Planning; Single session brief safety planning intervention (BSI) developed by Stanely & Brown	Behavioral: Safety Planning Intervention; The single-session safety planning intervention (SPI) will be provided according to protocols developed by Stanley & Brown. The SPI involves collaboratively creating a personalized, step-by-step plan to help individuals recognize warning signs, use coping strategies, seek support, and reduce access to means during a suicidal crisis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Suicidal thinking	Self-report of actual thoughts of suicide in the last 30 days	6 months
Number of participants with a Suicidal plan	Self-report of plan to attempt suicide	6 months
Number of participants with Suicidal intent	Self-report of intent to attempt suicide	6 months
Number of participants with Suicide preparatory behavior	Self-report of preparatory behavior such as writing a suicide note or preparing materials to attempt suicide	6 months
Number of participants with Suicide attempt	Self-report of harming oneself with the intention of ending one's life	6 months
Number of participants with HIV care engagement	Single triangulated variable (yes/no) integrating self-reported antiretroviral medication adherence, HIV clinic attendance, and HIV viral load	6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: RTI International
• Investigators: Principal Investigator: Brandon A Knettel, Ph.D., Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIV; health behavior; telehealth; suicide prevention; stigma reduction; task-shifting; task-sharing; care engagement; nurse-led intervention
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Behavioral Symptoms; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Self-Injurious Behavior; Slow Virus Diseases; Suicide; HIV Infections; Behavior; Suicide Prevention; Acquired Immunodeficiency Syndrome; Health Behavior
• Other Study ID Numbers: Pro00119742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Age, sex, ethnicity, socioeconomic status, depression symptoms, distress, suicide risk, suicide coping self-efficacy, hopelessness, reasons for living, anxiety symptoms, traumatic stress symptoms, impairment, resilience, social support, quality of life, study feedback, method and date of HIV diagnosis, antiretroviral therapy (ART) use and date of initiation, ART adherence, persistence, and retention, beliefs about ART, stigma, HIV knowledge, HIV acceptance.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No