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

NCT06247527 | Not Yet Recruiting DMC

• 1 other identifier: R01MH133261
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety; Trauma; HIV-1-infection

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Viral suppression

  6 months and 12 months

Other Outcomes (2)

• Reach

  Early implementation (3 months) and late implementation (12 months)

• Implementation fidelity

  Early implementation (3 months) and late implementation (12 months)

Study Arms (2)

PROACT group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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

Also known as: PROACT, Trauma-focused Cognitive Behavioral Therapy

PROACT group

Standard of care BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nairobi: lead
• University of Washington: collaborator
• Johns Hopkins University: collaborator
• Kenyatta National Hospital: collaborator

Study Sites (1)

University of Nairobi

Nairobi, 00202, Kenya

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Wounds and Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Dalton Wamalwa, MPH

CONTACT

+254721239493; dalton@africaonline.co.ke

Cyrus Mugo, PhD

CONTACT

+254721599626; cyrusmugodr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Providers and participants will know the assigned arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 8, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The protocol will be available upon publication by June 2024 and the IPD will be available after publication of relevant papers
• Access Criteria: Upon request to the study Principal Investigator

Locations

KE (1)