HIV - Human Immunodeficiency VirusNCT07459218
IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania
A study testing IDEAS for Hope and Safety Planning Intervention in people with HIV - Human Immunodeficiency Virus and Suicide Prevention, run by Duke University at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV - Human Immunodeficiency Virus, Suicide Prevention
- What is being tested?
- IDEAS for Hope and Safety Planning Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Dec 2026to Aug 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- Living with HIV
- Attending HIV care appointments
- Self-report experiencing thoughts of suicide in the last 30 days
Who cannot join
- Physically or cognitively unable to provide informed consent or complete study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tanzania1 site
Kilimanjaro Clinical Research Institute
Moshi
Blandina Mmbaga, MD, MMED, PhD, +255 27 275 4201, b.mmbaga@kcri.ac.tz
About this study
Official title: 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.
Read the 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.
- Being tested
- IDEAS for Hope, Safety Planning Intervention
- Keywords
- task-shifting, task-sharing, stigma reduction, suicide prevention, health behavior, care engagement, HIV, telehealth, nurse-led intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Suicide Prevention, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDEAS for HopeBehavioural
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.
Safety Planning InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| IDEAS for Hope | Experimental | 3-session, nurse-delivered, telehealth counseling intervention developmed by Knettel and colleagues Receives: Behavioral: IDEAS for Hope |
| Brief Safety Planning | Active comparator | Single session brief safety planning intervention (BSI) developed by Stanely \& Brown Receives: Behavioral: Safety Planning Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Suicidal thinking
Self-report of actual thoughts of suicide in the last 30 days
Measured: 6 months
Number of participants with a Suicidal plan
Self-report of plan to attempt suicide
Measured: 6 months
Number of participants with Suicidal intent
Self-report of intent to attempt suicide
Measured: 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
Measured: 6 months
Number of participants with Suicide attempt
Self-report of harming oneself with the intention of ending one's life
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Dec 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV - Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International
- Responsible party
- Sponsor
- Investigators
- Brandon A Knettel, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459218
- Sponsor's protocol ID
- Pro00119742
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.