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Clinical Trials/NCT07459218
NCT07459218
Not yet recruiting
Not Applicable

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

Duke University1 site in 1 country600 target enrollmentStarted: August 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
600
Locations
1
Primary Endpoint
Number of participants with Suicidal thinking

Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Arms & Interventions

IDEAS for Hope

Experimental

3-session, nurse-delivered, telehealth counseling intervention developmed by Knettel and colleagues

Intervention: IDEAS for Hope (Behavioral)

Brief Safety Planning

Active Comparator

Single session brief safety planning intervention (BSI) developed by Stanely & Brown

Intervention: Safety Planning Intervention (Behavioral)

Outcomes

Primary Outcomes

Number of participants with Suicidal thinking

Time Frame: 6 months

Self-report of actual thoughts of suicide in the last 30 days

Number of participants with a Suicidal plan

Time Frame: 6 months

Self-report of plan to attempt suicide

Number of participants with Suicidal intent

Time Frame: 6 months

Self-report of intent to attempt suicide

Number of participants with Suicide preparatory behavior

Time Frame: 6 months

Self-report of preparatory behavior such as writing a suicide note or preparing materials to attempt suicide

Number of participants with Suicide attempt

Time Frame: 6 months

Self-report of harming oneself with the intention of ending one's life

Number of participants with HIV care engagement

Time Frame: 6 months

Single triangulated variable (yes/no) integrating self-reported antiretroviral medication adherence, HIV clinic attendance, and HIV viral load

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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