Menu
Recruiting NCT06770101

Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe

No phase Interventional HIV Suicide

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral: Enhanced Friendship Bench + Safety Planning, Augmented usual care.
Who it may be relevant to
Registry conditions: HIV, Suicide. Basic parameters: 13 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malawi
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe: SAFETY Planning Pilot Trial

Overview

The overall aim of this study is to determine the feasibility, fidelity, acceptability, and preliminary effectiveness of the Friendship Bench +Safety Planning intervention in reducing suicidal ideation and behaviors (SIBs) and improving HIV engagement amongst adolescents living with HIV (ALWH) when compared to augmented usual care.

Detailed description

This project aims to evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the enhanced Friendship Bench+Safety Planning (FB+SP) intervention model. We will enroll 60 depressed ALWH who report suicidality from four facilities in Lilongwe, Malawi, and randomize them 1:1 to the enhanced FB+SP model or augmented usual care. This pilot trial is a step toward our long-term goal of generating and implementing an evidence-based model to prevent suicide in Malawi amongst ALWH by enhancing the capacity of the health system to identify suicidality and provide evidence-based care. Information gathered in this proposal will be used to develop a subsequent randomized control trial.

Interventions

  • Behavioral Behavioral: Enhanced Friendship Bench + Safety Planning
    The protocol will include six sessions, starting with the development of the SP during the first session. Each of the following sessions will include SIBs and suicide risk assessments, SP check-ins and revisions, as well as FB problem-solving to address SIBs and suicide risk. SP+FB will be delivered by selection of young counselors (mixed genders, aged 20-35) who are motivated to work with young people. Counseling sessions will take place in a discrete location within the HIV clinic and be avail
  • Behavioral Augmented usual care
    Care for suicidality in public facilities in Malawi includes options for basic supportive counseling by the primary provider or nurse, medication management by the primary provider, referral to the clinic's psychiatric nurse, or, for acute cases or crises, referral to the psychiatric units at tertiary care hospitals (Bwaila Hospital in Lilongwe District). Nurses and clinicians at the study sites have been specifically trained to use the Tool for Assessment of Suicide Risk for Adolescents (TASR-A

Primary outcome measures

  • Study retention (study feasibility) [Time frame: Through study completion- 6 months]
  • Recruitment rate (Intervention feasibility) [Time frame: Baseline]
  • Overall satisfaction with the intervention among participants (intervention acceptability) [Time frame: 6 months]
  • Proportion of sessions meeting fidelity threshold (intervention fidelity) [Time frame: 6 months]
Secondary outcome measures (3)
  • Prevalence of suicidal ideation and behaviors [Time frame: 6 months]
  • Prevalence of suicide risk [Time frame: 6 months]
  • Prevalence of depressive symptoms [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Age 13-19
  • Diagnosed with HIV
  • Report current or historical suicidal ideation and behaviors (SIBs) on question 9 of the Patient Health Questionnaire modified for adolescents (PHQ-9-A) and the Ask Suicide-Screening questionnaire (ASQ)
  • Living in the clinic's catchment area with intention to remain for more than 1 year
  • Willing to provide consent (age 18+ or 16-17 years old and married and thereby considered emancipated minors per Malawi law) or assent with parental consent (age 13-17).

Exclusion criteria

  • Refuse to participate
  • Refuse to be audio-taped for in-depth interviews

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Malawi · 4 centers
  • Area 18 Health Center — Lilongwe
  • Area 25 Health Center — Lilongwe
  • Kawale Health Center — Lilongwe
  • Lighthouse Health Center — Lilongwe

Publications

  • Stockton MA, Waddell K, Mphonda SM, Bhushan NL, January J, Masulani C, Brown G, Udedi MM, Pence BW, Chiwanda J, Gaynes BN, Kulisewa K. Suicide assessment and feasible evidence-based treatments for adolescents living with HIV in Malawi: Protocol for a pilot randomized controlled trial. PLoS One. 2025 Sep 3;20(9):e0330847. doi: 10.1371/journal.pone.0330847. eCollection 2025. PMID 40901775

Identifiers

NCT: NCT06770101 · 857370 · R34MH136204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗