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.
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
If any study procedure would put them at an increased risk or if their compliance with study procedures is not possible
Parallel
Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping Therapy
BehavioralThis is a brief transdiagnostic psychological intervention based on the trauma-focused cognitive behavioral therapy (TF-CBT) designed for delivery by non-specialist providers to adolescents and youth with psychological distress
Standard of care
BehavioralAny intervention, including counseling, provided as a routine intervention at the HIV clinic selected as a control clinic
Depressive symptoms
Symptoms measured using the 9-item Patient Health Questionnaire. Scores range from 0 to 27. Higher scores indicate more severe depressive symptoms
Anxiety
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
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
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
Viral suppression
HIV viral load measured from abstracted clinic records and defined as viral load of \<200 copies/ml
Reach
Proportion of AYHIV in intervention versus control clinics routinely screened using the PHQ-2/PHQ-9 tool out of total AYHIV who should be screened; and proportion of AYHIV in intervention clinics with psychological distress enrolled in the psychological intervention
Implementation fidelity
Proportion of intervention clinics implementing PROACT with high fidelity. Assessed using a standardized checklist and self-report
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University of Nairobi
Lead sponsor
University of Washington
Collaborator
Johns Hopkins University
Collaborator
Kenyatta National Hospital
Collaborator
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