Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06247527

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping Therapy

Behavioral

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: PROACT, Trauma-focused Cognitive Behavioral Therapy

Standard of Care

Behavioral

Any intervention, including counseling, provided as a routine intervention at the HIV clinic selected as a control clinic

Primary outcomes

  1. Depressive symptoms

    Time frame: 6 months and 12 months

    Symptoms measured using the 9-item Patient Health Questionnaire. Scores range from 0 to 27. Higher scores indicate more severe depressive symptoms

  2. Anxiety

    Time frame: 6 months and 12 months

    Symptoms measured using the 7-item Generalized Anxiety Disorder scale. Scores range from 0 to 21. Higher scores indicate more severe anxiety

  3. Trauma symptoms for AYHIV <18 years

    Time frame: 6 months and 12 months

    Symptoms measured using the Child and Adolescent Trauma Screen. Scores range from 0 to 60. Higher scores indicate more severe trauma distress symptoms

  4. Trauma symptoms for AYHIV ≥18 years

    Time frame: 6 months and 12 months

    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

Secondary outcomes

  1. Viral suppression

    Time frame: 6 months and 12 months

    HIV viral load measured from abstracted clinic records and defined as viral load of <200 copies/ml

Other outcomes

  1. Reach

    Time frame: Early implementation (3 months) and late implementation (12 months)

    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

  2. Implementation fidelity

    Time frame: Early implementation (3 months) and late implementation (12 months)

    Proportion of intervention clinics implementing PROACT with high fidelity. Assessed using a standardized checklist and self-report

Study contacts

Contact information is provided by the study sponsor or research team.

Cyrus Mugo, PhD

CONTACT

[email protected]

+254721599626

Dalton Wamalwa, MPH

CONTACT

[email protected]

+254721239493

Sponsors and collaborators

Lead sponsor

University of Nairobi

Other

Collaborators

  • Johns Hopkins University
  • Kenyatta National Hospital
  • University of Washington

Registry information

Official study title

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

Acronym: PROACT

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.