NCT06770101|Recruiting
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Sponsor study identifier
Secondary identifiers
NIH
interventional
60
1 country
4
Study Start
July 1, 2025
Actual (reported)Primary Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 9, 2025
Actual (reported)January 13, 2025
Actual (reported)July 1, 2025
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Prevalence of suicidal ideation and behaviors
6 months
Prevalence of suicide risk
6 months
Prevalence of depressive symptoms
6 months
Friendship Bench (FB) problem-solving therapy and Safety Planning (SP)
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.
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.
Area 18 Health Center
Lilongwe, Malawi
Area 25 Health Center
Lilongwe, Malawi
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.
Melissa Stockton, PhD
University of Pennsylvania
First Submitted
January 9, 2025
First Posted
January 13, 2025
Study Start
July 1, 2025
Actual (reported)Primary Completion
Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities
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.
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Contact the study team to confirm eligibility.
Kawale Health Center
Lilongwe, Malawi
Lighthouse Health Center
Lilongwe, Malawi
September 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 5, 2026
Record last verified: 2026-06
Deidentified data will be posted to the National Insititute of Mental Health (NIMH) Data Archive pursuant to the requirements of that site.
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Source: ClinicalTrials.gov.
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