Clinical trial NCT06770101: Suicide Assessment and Feasible Evidence-based Treatments for Youth Living with HIV in Lilongwe
Official title: Suicide Assessment and Feasible Evidence-based Treatments for Youth Living with HIV in Lilongwe: SAFETY Planning Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Suicide
Keywords: HIV
Suicide
Suicidal Ideation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm individually randomized pilot study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Study retention (study feasibility)
timeFrame: Through study completion- 6 months
measure: Recruitment rate (Intervention feasibility)
timeFrame: Baseline
measure: Overall satisfaction with the intervention among participants (intervention acceptability)
timeFrame: 6 months
measure: Proportion of sessions meeting fidelity threshold (intervention fidelity)
timeFrame: 6 months
Secondary outcomes:
measure: Prevalence of suicidal ideation and behaviors
timeFrame: 6 months
measure: Prevalence of suicide risk
timeFrame: 6 months
measure: Prevalence of depressive symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Area 18 Health Center
city: Lilongwe
country: Malawi
facility: Area 25 Health Center
city: Lilongwe
country: Malawi
facility: Kawale Health Center
city: Lilongwe
country: Malawi
facility: Lighthouse Health Center
Study officials:
affiliation: University of Pennsylvania
name: Melissa Stockton, PhD
role: PRINCIPAL_INVESTIGATOR
References: