NCT07459218

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
60mo left

Started Aug 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2031

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

March 4, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

task-shiftingtask-sharingstigma reductionsuicide preventionhealth behaviorcare engagementHIVtelehealthnurse-led intervention

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

IDEAS for Hope

EXPERIMENTAL

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

Behavioral: IDEAS for Hope

Brief Safety Planning

ACTIVE COMPARATOR

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

Behavioral: Safety Planning Intervention

Interventions

IDEAS for HopeBEHAVIORAL

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.

IDEAS for Hope

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.

Brief Safety Planning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilimanjaro Clinical Research Institute

Moshi, Tanzania

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSuicide PreventionHealth Behavior

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Brandon A Knettel, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon A Knettel, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 9, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 31, 2031

Study Completion (Estimated)

June 30, 2031

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations