Assessment domains, constructs, and measures.

BackgroundThis pilot trial will investigate the feasibility, acceptability, fidelity, and preliminary efficacy of a combined youth-friendly suicide prevention and problem-solving intervention in reducing suicidal ideation and behaviors in adolescents living with HIV (ALWH) in Malawi.MethodsALWH (N = 60) aged 13–19 who reported suicidal ideation and behaviors will be recruited from 5 health clinics. Participants will be randomized 1:1 either to the Safety Planning and Friendship Bench (SP + FB) (n = 30) or to augmented usual care (n = 30) and followed for 6 months. SP + FB includes 6 individual counseling sessions and 6 bi-monthly peer support group sessions delivered by psychological counselors. Feasibility, acceptability, fidelity, and preliminary efficacy will be assessed at 6-weeks and 3- and 6-month study visits and compared across the 2 study arms.DiscussionThe results of this study will provide insights into the feasibility, acceptability, fidelity, and preliminary efficacy of the combined SP + FB for reducing chronic and acute suicidality in ALWH compared to standard of care. This pilot study will lay the groundwork to test the SP + FB in a large-scale cluster randomized controlled trial to improve suicide prevention resources and interventions for ALWH in Malawi. The findings of the study will add to a critical body of research aiming to implement feasible, acceptable, and effective suicide prevention interventions as part of adolescent HIV care in low-resource settings.Trial registerationClinicalTrials.gov: NCT06770101背景 本先导临床试验将评估一项青年友好型自杀预防与问题解决联合干预措施在降低马拉维艾滋病病毒感染者青少年（Adolescents Living with HIV, ALWH）自杀意念与自杀行为方面的可行性、可接受性、干预保真度及初步疗效。 方法 本研究将从5家卫生诊所招募60名年龄介于13~19岁、报告存在自杀意念与自杀行为的艾滋病病毒感染者青少年。参与者将以1:1比例随机分配至安全计划与友谊长椅（Safety Planning and Friendship Bench, SP+FB）组（n=30）或强化常规护理组（n=30），并接受为期6个月的随访。SP+FB干预包含由心理咨询师提供的6次个体心理咨询会谈与6次每两月一次的同伴支持小组会谈。研究将在随访第6周、3个月及6个月的访视中评估可行性、可接受性、干预保真度与初步疗效，并在两个研究组间开展对比分析。 讨论 本研究结果将阐明相较于标准护理，SP+FB联合干预用于降低艾滋病病毒感染者青少年慢性与急性自杀倾向的可行性、可接受性、干预保真度及初步疗效。本先导研究将为后续开展大规模整群随机对照试验验证SP+FB干预效果奠定基础，以改善马拉维艾滋病病毒感染者青少年的自杀预防资源与干预措施。本研究发现将为旨在资源匮乏地区将自杀预防干预纳入青少年艾滋病护理体系的关键研究领域补充实证依据，此类干预需兼具可行性、可接受性与有效性。 临床试验注册 ClinicalTrials.gov: NCT06770101