Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-29
Brief Title:
Psychoeducation Relaxation PrOblem Solving Activation Cognitive Coping Therapy for Adolescents and Youth in HIV Care
Sponsor:
University of Nairobi
Organization:
University of Nairobi
Study Overview
Official Title:
Integrating a Transdiagnostic Psychological Intervention In The Care For Adolescents And Youth With HIV In Kenya
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROACT
Brief Summary:
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
Detailed Description:
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 interventions implementation activities within the 30 clinics in participating in the study to estimate the implementation costs from a patient and health system perspective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None