跳至主要内容
临床试验/NCT06247527
NCT06247527尚未招募不适用

Integrating a Transdiagnostic Psychological Intervention In The Care For Adolescents And Youth With HIV In Kenya

University of Nairobi2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
试验地点
2
主要终点
Depressive symptoms

研究概览

简要总结

The proposed PROACT study will test the effectiveness of a mental health intervention (psychotherapy) for multiple common mental health conditions (depressive, anxiety and trauma symptoms) among adolescents and youth with HIV in Kenya. The study will also evaluate key factors for successful intervention implementation and conduct an economic evaluation to inform future intervention scale-up.

详细描述

Depression, anxiety, and trauma are common mental disorders that disproportionately affect adolescents and youth with HIV (AYHIV), and are associated with antiretroviral treatment (ART) non-adherence and poor treatment outcomes. The integration of mental health services in HIV care for AYHIV is recommended, but is lacking due to few trained mental health providers, and lack of a well validated integration models. Transdiagnostic interventions based on cognitive behavioral therapy (CBT) and delivered by lay health workers are effective in addressing these mental health conditions and could potentially improve HIV treatment outcomes. Barriers to integration of these interventions in the care of AYHIV in sub-Saharan Africa include paucity of effectiveness data among AYHIV and the lack of adaptation to tailor implementation for the HIV care context, including the length of treatment (number and frequency of sessions) and the format of delivery. This proposal builds on the successful pilot of 'Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping Therapy' (PROACT), a brief, modular and transdiagnostic intervention for adolescents and youth with mild to moderate symptoms of depression and anxiety in Kenya that resulted in clinically significant reduction in symptoms. The intervention can be delivered in stand-alone modules either in person or by phone, making it particularly appropriate for AYHIV when school is in session. In this project, we propose to further adapt PROACT for the HIV care setting through a stakeholder engagement process with policymakers, mental health and adolescent HIV practitioners, and AYHIV. Using a hybrid 1 cluster randomized trial in 30 HIV clinics in Kenya, we will assess the effectiveness of PROACT in reducing depressive, anxiety and trauma symptoms 6 months and 12 months after enrolment, comparing 300 AYHIV with mild to moderate symptoms in intervention to 300 in control clinics. To inform the integration of the intervention in routine care, we will measure implementation outcomes including reach, fidelity and maintenance, and explore multilevel determinants influencing reach, fidelity and maintenance in mental health screening and management, acceptability of training by providers and satisfaction with services by AYHIV. We will also conduct an economic evaluation through a time-driven activity-based costing of the intervention's implementation activities within the 30 clinics in participating in the study to estimate the implementation costs from a patient and health system perspective.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Providers and participants will know the assigned arm

入排标准

年龄范围
16 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent or youth ages 16-24 years attending HIV clinic at selected site with at least mild psychological distress who is willing to join the study and capable of providing consent to receive the intervention

排除标准

  • If any study procedure would put them at an increased risk or if their compliance with study procedures is not possible

结局指标

主要结局

Depressive symptoms

时间窗: 6 months and 12 months

Symptoms measured using the 9-item Patient Health Questionnaire. Scores range from 0 to 27. Higher scores indicate more severe depressive symptoms

Anxiety

时间窗: 6 months and 12 months

Symptoms measured using the 7-item Generalized Anxiety Disorder scale. Scores range from 0 to 21. Higher scores indicate more severe anxiety

Trauma symptoms for AYHIV <18 years

时间窗: 6 months and 12 months

Symptoms measured using the Child and Adolescent Trauma Screen. Scores range from 0 to 60. Higher scores indicate more severe trauma distress symptoms

Trauma symptoms for AYHIV ≥18 years

时间窗: 6 months and 12 months

Symptoms measured using the Post Traumatic Stress Disorder checklist for 5th edition of the Diagnostic and Statistical Manual of Mental Disorders. Scores range from 0 to 80. Higher scores indicate more severe trauma distress symptoms

次要结局

  • Viral suppression(6 months and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dalton Wamalwa

Associate Professor

University of Nairobi

研究点 (2)

Loading locations...

相似试验