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

Официальное название

Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe: SAFETY Planning Pilot Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Behavioral: Enhanced Friendship Bench + Safety Planning
  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 avail
• Поведенческое Augmented usual care
  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

Первичные конечные точки

• Study retention (study feasibility) [Срок оценки: Through study completion- 6 months]
• Recruitment rate (Intervention feasibility) [Срок оценки: Baseline]
• Overall satisfaction with the intervention among participants (intervention acceptability) [Срок оценки: 6 months]
• Proportion of sessions meeting fidelity threshold (intervention fidelity) [Срок оценки: 6 months]

Вторичные конечные точки (3)

• Prevalence of suicidal ideation and behaviors [Срок оценки: 6 months]
• Prevalence of suicide risk [Срок оценки: 6 months]
• Prevalence of depressive symptoms [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• Refuse to participate
• Refuse to be audio-taped for in-depth interviews

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Malawi · 4 центра

• Area 18 Health Center — Lilongwe
• Area 25 Health Center — Lilongwe
• Kawale Health Center — Lilongwe
• Lighthouse Health Center — Lilongwe

Публикации

• 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. PMID 40901775

Идентификаторы

NCT: NCT06770101 · 857370 · R34MH136204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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