Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe
HIV · Suicide
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 13 years - 19 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 60 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Enhanced Friendship Bench + Safety Planning (FB+SP)
Friendship Bench (FB) problem-solving therapy and Safety Planning (SP)
Behavioral: Behavioral: Enhanced Friendship Bench + Safety Planning
Augmented Usual Care
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
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.
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Study retention (study feasibility)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 measures
Prevalence of suicidal ideation and behaviors
Time frame: 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
Time frame: 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
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (4)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
4 locations
Area 18 Health CenterLilongwe, MalawiStatus unknown
Area 25 Health CenterLilongwe, MalawiStatus unknown
Kawale Health CenterLilongwe, MalawiStatus unknown
Lighthouse Health CenterLilongwe, MalawiStatus unknown
Study team and timeline
- Lead sponsor
- University of Pennsylvania
- Study start
- Jul 1, 2025 Actual
- Primary completion
- Sep 18, 2026 Actual
- Study completion
- Nov 30, 2026 Estimated
- First posted
- Jan 13, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe: SAFETY Planning Pilot Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026
