An interventional study of IDEAS for Hope and Safety Planning Intervention in HIV - Human Immunodeficiency Virus and Suicide Prevention, sponsored by Duke University. Not yet recruiting at 1 site in Tanzania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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.
186 studies on the registry are indexed under Suicide Prevention; 92 are open to participants now.
This study's planned enrollment of 600 is above the median of 140 across 167 interventional studies indexed under Suicide Prevention.
Browse Suicide Prevention studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Compared within Suicide Prevention, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3-session, nurse-delivered, telehealth counseling intervention developmed by Knettel and colleagues
Behavioral: IDEAS for Hope
Single session brief safety planning intervention (BSI) developed by Stanely \& Brown
Behavioral: Safety Planning Intervention
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.
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.
Number of participants with Suicidal thinking
Self-report of actual thoughts of suicide in the last 30 days
Time frame: 6 months
Number of participants with a Suicidal plan
Self-report of plan to attempt suicide
Time frame: 6 months
Number of participants with Suicidal intent
Self-report of intent to attempt suicide
Time frame: 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
Time frame: 6 months
Number of participants with Suicide attempt
Self-report of harming oneself with the intention of ending one's life
Time frame: 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
Time frame: 6 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Aug 2031, 56 months later.
Of 127 non-industry interventional studies with no phase under Suicide Prevention, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's planned 56 months is above that.
Counting every sponsor, half of 129 studies reached it within 28 months; a quarter within 12 and three quarters within 53.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 14, 2026: start Aug 2026 → Dec 2026, primary completion Jan 2031 → Aug 2031 and completion Jun 2031 → Aug 2031.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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