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

February 6, 2024 updated by: Dalton Wamalwa, University of Nairobi

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months and 12 months
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
6 months and 12 months
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
6 months and 12 months
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
6 months and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 months and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Early implementation (3 months) and late implementation (12 months)
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
Early implementation (3 months) and late implementation (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nairobi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
University of Washington
Kenyatta National Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings