Psychoeducation, Relaxation, PrOblem Solving, Activation, Cognitive Coping Therapy for Adolescents and Youth in HIV Care

Trauma Clinical Trial

— PROACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06247527
• Other study ID #: R01MH133261
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2028

Study information

• Verified date: February 2024
• Source: University of Nairobi
• Contact: Dalton Wamalwa, MPH
• Phone: +254721239493
• Email: dalton[@]africaonline.co.ke
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• HIV-1-infection
• Trauma

Intervention

Behavioral:
• Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping Therapy
This 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
Any intervention, including counseling, provided as a routine intervention at the HIV clinic selected as a control clinic

Locations

Country	Name	City	State
Kenya	University of Nairobi	Nairobi

Sponsors (4)

Lead Sponsor	Collaborator
University of Nairobi	Johns Hopkins University, Kenyatta National Hospital, University of Washington

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Early implementation (3 months) and late implementation (12 months)
Other	Implementation fidelity	Proportion of intervention clinics implementing PROACT with high fidelity. Assessed using a standardized checklist and self-report	Early implementation (3 months) and late implementation (12 months)
Primary	Depressive symptoms	Symptoms measured using the 9-item Patient Health Questionnaire. Scores range from 0 to 27. Higher scores indicate more severe depressive symptoms	6 months and 12 months
Primary	Anxiety	Symptoms measured using the 7-item Generalized Anxiety Disorder scale. Scores range from 0 to 21. Higher scores indicate more severe anxiety	6 months and 12 months
Primary	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	6 months and 12 months
Primary	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	6 months and 12 months
Secondary	Viral suppression	HIV viral load measured from abstracted clinic records and defined as viral load of <200 copies/ml	6 months and 12 months