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

NCT06770101 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-08

No results posted yet for this study

Summary

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.

Conditions

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 available on weekends. Each structured session lasts 30-45 minutes and conducted in the participant's local language (Chichewa). After 4 sessions of individual therapy, the counselor can refer participants not improving or with suicidal ideation to a supervisor trained in mental health to reassess and manage the case. Case management may include additional counseling or pharmacotherapy, at the discretion of the managing clinician. Participants may also receive text message support and peer-support.

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) to assess ALWH considered at elevated risk for suicide. For this study, usual care will be augmented by a trained study nurse who will provide mental health evaluation, brief supportive counseling, information, education and support on SIBs, and (if indicated) facilitation of referral to the clinic's psychiatric nurse or to Bwaila Hospital.

Sponsors & Collaborators

Principal Investigators

  • Melissa Stockton, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-14
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Malawi

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06770101 on ClinicalTrials.gov