Depression, AnxietyPROACTNCT06247527
Psychoeducation, Relaxation, PrOblem Solving, Activation, Cognitive Coping Therapy for Adolescents and Youth in HIV Care
A study testing Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping Therapy in people with Depression, Anxiety and Trauma, run by University of Nairobi at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Depression, Anxiety, Trauma, HIV-1-infection
- What is being tested?
- Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteKenya
- Study dates
- May 2024to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- If any study procedure would put them at an increased risk or if their compliance with study procedures is not possible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site
University of Nairobi
Nairobi, 00202
Dalton Wamalwa, MPH, +254721239493, dalton@africaonline.co.ke
Cyrus Mugo, PhD, +254721599626, cyrusmugodr@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Anxiety, Trauma, HIV-1-infection
- Being tested
- Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping Therapy, Standard of care
- Medical subject headings
- Depression, Anxiety Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping TherapyBehavioural
Also called PROACT, Trauma-focused Cognitive Behavioral 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 careBehavioural
Any intervention, including counseling, provided as a routine intervention at the HIV clinic selected as a control clinic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Symptoms measured using the 9-item Patient Health Questionnaire. Scores range from 0 to 27. Higher scores indicate more severe depressive symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months and 12 months
Secondary outcomes (1)
Viral suppression
HIV viral load measured from abstracted clinic records and defined as viral load of <200 copies/ml
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study startMay 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nairobi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Johns Hopkins University, Kenyatta National Hospital
- Responsible party
- Principal investigator, Dalton Wamalwa, University of Nairobi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247527
- Sponsor's protocol ID
- R01MH133261
- Acronym
- PROACT
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Mugo C, Njuguna I, Maganga V, Flaherty BP, Wagner AD, Mukumbang FC, Dorsey S, Mwai D, Mburu C, Kumar M, Mbwayo A, Mathai M, Collins PY, Wamalwa D. Integration of a brief, transdiagnostic psychological intervention in the care of adolescents and young adults with HIV in Kenya: Protocol for a cluster randomized clinical trial. PLoS One. 2025 Jun 20;20(6):e0325374. doi: 10.1371/journal.pone.0325374. eCollection 2025.
PubMed 40540521
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating a Transdiagnostic Psychological Intervention In The Care For Adolescents And Youth With HIV In Kenya
- ClinicalTrials.gov ID
- NCT06247527
- Acronym / sponsor ID
- PROACT / R01MH133261
- Conditions
- Depression, Anxiety, Trauma, HIV-1-infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of NairobiUniversity, hospital or other
- Collaborators
- University of Washington, Johns Hopkins University, Kenyatta National Hospital
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PROACT group | Experimental | Behavioral: Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping TherapyParticipants 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. |
| Control group | Active comparator | Behavioral: Standard of careParticipants 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. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- If any study procedure would put them at an increased risk or if their compliance with study procedures is not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping TherapyAlso: PROACT, Trauma-focused Cognitive Behavioral TherapyThis 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 | Behavioural | PROACT group |
| Standard of careAny intervention, including counseling, provided as a routine intervention at the HIV clinic selected as a control clinic | Behavioural | Control group |
Primary outcome
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
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
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
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
1 secondary outcome
Viral suppression
Time frame: 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 40540521Mugo C, Njuguna I, Maganga V, Flaherty BP, Wagner AD, Mukumbang FC, Dorsey S, Mwai D, Mburu C, Kumar M, Mbwayo A, Mathai M, Collins PY, Wamalwa D. Integration of a brief, transdiagnostic psychological intervention in the care of adolescents and young adults with HIV in Kenya: Protocol for a cluster randomized clinical trial. PLoS One. 2025 Jun 20;20(6):e0325374. doi: 10.1371/journal.pone.0325374. eCollection 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation, Relaxation, PrOblem solving, Activation, Cognitive coping Therapy in people with Depression, Anxiety and Trauma, run by University of Nairobi at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalton Wamalwa, MPH (+254721239493, dalton@africaonline.co.ke), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: 6 months and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06247527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.