Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe
HIV · Suicide
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 13 años - 19 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 60 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Study retention (study feasibility)
Plazo: 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)
Plazo: 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)
Plazo: 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)
Plazo: 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.
Medidas secundarias
Prevalence of suicidal ideation and behaviors
Plazo: 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
Plazo: 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
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (4)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
4 centros
Area 18 Health CenterLilongwe, MalawiEstado desconocido
Area 25 Health CenterLilongwe, MalawiEstado desconocido
Kawale Health CenterLilongwe, MalawiEstado desconocido
Lighthouse Health CenterLilongwe, MalawiEstado desconocido
Equipo y fechas
- Patrocinador principal
- University of Pennsylvania
- Inicio del estudio
- 1 jul 2025 Real
- Finalización primaria
- 18 sept 2026 Real
- Finalización del estudio
- 30 nov 2026 Estimado
- Primera publicación
- 13 ene 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe: SAFETY Planning Pilot Trial
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026
