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

Not Applicable

Not yet recruiting

• Conditions: HIV; Suicide

• Registration Number: NCT06770101
• Lead Sponsor: University of Pennsylvania

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.

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-13
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Study Start: 2025-07
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Study retention (study feasibility)	Through study completion- 6 months	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.
Recruitment rate (Intervention feasibility)	Baseline	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).
Overall satisfaction with the intervention among participants (intervention acceptability)	6 months	The proportion of participants who found the intervention acceptable and helpful among all participants who received the intervention.
Proportion of sessions meeting fidelity threshold (intervention fidelity)	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of suicidal ideation and behaviors	6 months	The proportion of participants in each arm who report experiencing suicidal ideation and behaviors out of all participants in that arm. Suicidal ideation and behaviors will be documented using question 9 of the Patient Health Questionnaire-9 modified for Adolescents (PHQ-A), which is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression with scores ranging from 0 to 27, where higher scores indicate greater self-reported depression and the Ask Suicide-Screening Questions (ASQ), which is a brief screening tool of five yes/no items addressing suicide risk.
Prevalence of suicide risk	6 months	The proportion of participants in each arm with passive to active suicide risk out of all participants in that arm. Suicide risk will be measured using the study's Suicide Risk Assessment Protocol.
Prevalence of depressive symptoms	6 months	The proportion of participants in each arm who report elevated depressive symptoms out of all participants in that arm. Depressive symptoms will be measured using the Patient Health Questionnaire-9 modified for Adolescents (PHQ-A) which is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression with scores ranging from 0 to 27, where higher scores indicate greater self-reported depression.

Trial Locations

Locations (4)

Area 18 Health Center; 🇲🇼 Lilongwe, Malawi

Kawale Health Center; 🇲🇼 Lilongwe, Malawi

Lighthouse Health Center; 🇲🇼 Lilongwe, Malawi

Area 25 Health Center; 🇲🇼 Lilongwe, Malawi