Project Summary/Abstract
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
(PRO-ACT), 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 PRO-
ACT for the HIV care setting through a stakeholder engagement process with policymakers, mental health and
adolescent HIV practitioners, and AYHIV. To prepare for the execution of trial, the stakeholders will identify and
prioritize potential barriers to implementation and suggest adaptations to the implementation process that
address key barriers. A pilot study at an HIV clinic with 10 providers and 20 AYHIV with mild to moderate
symptoms will enable the study team to further adapt the intervention and study procedures. Using a hybrid 1
cluster randomized trial in 30 HIV clinics in Kenya, we will assess the effectiveness of PRO-ACT 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- activities within the
30 clinics in participating in the study to estimate the implementation costs from a patient and health system
perspective.
