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

NCT06770101 | Recruiting

• 2 other identifiers: 857370R34MH136204
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief 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

HIV; Suicide

Keywords

HIV; Suicide; Suicidal Ideation

Outcome Measures

Primary Outcomes (4)

• Study retention (study feasibility)

  This outcome measure of feasibility will be measured as the ability to retain ALWH in the pilot trial. Feasibility will be evaluated by measuring the number of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial) through study completion.

  Through study completion- 6 months

• Recruitment rate (Intervention feasibility)

  This outcome measure of feasibility will be measured as the ability to successfully enroll ALWH in the pilot trial. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).

  Baseline

• Overall satisfaction with the intervention among participants (intervention acceptability)

  The proportion of participants who found the intervention acceptable and helpful among all participants who received the intervention.

  6 months

• Proportion of sessions meeting fidelity threshold (intervention fidelity)

  The proportion of sessions meeting or exceeding expectations for at least 80% of the total number of fidelity checklist items assessed per session during random monitoring sessions out of all sessions monitored.

  6 months

Secondary Outcomes (3)

• Prevalence of suicidal ideation and behaviors

  6 months

• Prevalence of suicide risk

  6 months

• Prevalence of depressive symptoms

  6 months

Study Arms (2)

Enhanced Friendship Bench + Safety Planning (FB+SP)

EXPERIMENTAL

Friendship Bench (FB) problem-solving therapy and Safety Planning (SP)

Behavioral: Behavioral: Enhanced Friendship Bench + Safety Planning

Augmented Usual Care

ACTIVE COMPARATOR

Continue with usual outpatient care, augmented to 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.

Behavioral: Augmented usual care

Interventions

Behavioral: Enhanced Friendship Bench + Safety Planning BEHAVIORAL

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.

Enhanced Friendship Bench + Safety Planning (FB+SP)

Augmented usual care BEHAVIORAL

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.

Augmented Usual Care

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Area 18 Health Center

Lilongwe, Malawi

RECRUITING

Area 25 Health Center

Lilongwe, Malawi

RECRUITING

Kawale Health Center

Lilongwe, Malawi

RECRUITING

Lighthouse Health Center

Lilongwe, Malawi

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Suicide; Suicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Melissa Stockton, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Stockton, PhD

CONTACT

1-419-340-7476; melissaann.stockton@pennmedicine.upenn.edu

Kazione Kulisewa, MBBS MMed

CONTACT

+265-997-210-381; kkulisewa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: 2-arm individually randomized pilot study

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: June 14, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

MA (4)