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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma; Depression, Anxiety; HIV-1-infection
• Intervention / Treatment: Behavioral: Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping Therapy; Behavioral: Standard of care

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dalton Wamalwa, MPH; Phone Number: +254721239493; Email: dalton@africaonline.co.ke
• Study Contact Backup: Name: Cyrus Mugo, PhD; Phone Number: +254721599626; Email: cyrusmugodr@gmail.com

Study Locations

• Kenya
  • Nairobi, Kenya, 00202
    • University of Nairobi
    • Contact: Dalton Wamalwa, MPH; Phone Number: +254721239493; Email: dalton@africaonline.co.ke
    • Contact: Cyrus Mugo, PhD; Phone Number: +254721599626; Email: cyrusmugodr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROACT group; Participants in intervention clinics with at least mild psychological distress (having depressive, anxiety or trauma symptoms) will receive a brief, modular, transdiagnostic psychological intervention (PROACT) delivered by non-specialist health providers at the HIV clinic.	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; Other Names: Trauma-focused Cognitive Behavioral Therapy; PROACT
Active Comparator: Control group; Participants in control clinics with at least mild psychological distress (having depressive, anxiety or trauma symptoms) will be enrolled in the study, and will receive the standard of care interventions available in the HIV clinic.	Behavioral: Standard of care; Any intervention, including counseling, provided as a routine intervention at the HIV clinic selected as a control clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral suppression	HIV viral load measured from abstracted clinic records and defined as viral load of <200 copies/ml	6 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University of Nairobi
• Collaborators: Johns Hopkins University; University of Washington; Kenyatta National Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: R01MH133261 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified data collected from participants after publication upon request. Data will be provided in accordance with the applicable laws and regulations in the United States and Kenya, and following requirements as per the NOT-MH-14-015 on Data Sharing Expectations for NIMH-funded Clinical Trials. We will package our data in a user-friendly format to facilitate use by other investigators, with a codebook documenting all variable names and values. Common data elements will be used to the extent possible. Additionally, we will create a syntax file of all scoring algorithms for computed scales and strategies for identifying and managing missing data.
• IPD Sharing Time Frame: The protocol will be available upon publication by June 2024 and the IPD will be available after publication of relevant papers
• IPD Sharing Access Criteria: Upon request to the study Principal Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No