Depression in AdolescenceSTREAMSNCT07637058
Streamlined Treatment and Evidence-based Adolescent Counseling and Medication Support (STREAMS)
A study testing Streamlined Suubi+Adherence and Streamlined Interpersonal Psychotherapy Groups (IPT-G) in people with Depression in Adolescence, run by City University of New York, School of Public Health.
Trial summary
Combination interventions to address mental health and adherence to HIV care in low- and middle-income countries (LMICs), are crucial to achieving the UNAIDS 95-95-95 targets as one in four adolescents living with HIV (ALWHIV) experience poor mental health and this contributes to suboptimal medication adherence and… Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Depression in Adolescence
- What is being tested?
- Streamlined Suubi+Adherence and Streamlined Interpersonal Psychotherapy Groups (IPT-G)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Aug 2030
- 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 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Living with HIV with confirmation by medical report and aware of their status
- Living within a family (defined broadly, not necessarily with biological parents); - - Between the ages of 15 to 19 years
- Prescribed ART
- Score a 10 or greater on the PHQ-9
Who cannot join
- an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or caregiver.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Combination interventions to address mental health and adherence to HIV care in low- and middle-income countries (LMICs), are crucial to achieving the UNAIDS 95-95-95 targets as one in four adolescents living with HIV (ALWHIV) experience poor mental health and this contributes to suboptimal medication adherence and lack of viral suppression. Yet few evidence-based mental health and adherence interventions have been evaluated in sub-Saharan Africa (SSA), the region where the majority of the 1.7 million ALWHIV reside. STREAMS will determine if our streamlined combination intervention approach to mental health screening, provision of evidence-based interpersonal psychotherapy groups (IPT-G), and evidence-based family strengthening, and medication counseling is feasible and efficacious for ALWHIV in Uganda.
- Conditions
- Depression in Adolescence
- Being tested
- Streamlined Suubi+Adherence, Streamlined Interpersonal Psychotherapy Groups (IPT-G)
- Keywords
- HIV, Uganda, mental health, depression
- Medical subject headings
- Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streamlined Suubi+AdherenceBehavioural
Participants in this intervention arm will receive:
- Financial literacy training
- Youth savings accounts The intervention aims to strengthen economic stability and support long-term treatment adherence and psychosocial well-being.
Streamlined Interpersonal Psychotherapy Groups (IPT-G)Behavioural
- Participants in the IPT-G intervention arms will attend:
- Six weekly group counseling sessions,
- Conducted in groups of approximately 6-10 adolescents,
- Facilitated by trained StrongMinds counselors.
The sessions will focus on:
- Emotional wellbeing
- Relationships
- Coping with stress
- Grief and loss
- Social support
- Problem-solving skills
| Study group | Role | What they receive |
|---|---|---|
| streamlined IPT-G with streamlined Suubi+Adherence | Experimental | Streamlined IPT-G (6 weeks) one 90-min StrongMinds group counseling session per week \& Suubi+Adherence (36 weeks) Receives: Behavioral: Streamlined Suubi+Adherence; Behavioral: Streamlined Interpersonal Psychotherapy Groups (IPT-G) |
| streamlined IPT-G with SOC ART counseling | Experimental | Streamlined IPT-G (6 weeks) as described above \& Standard Of Care (SOC) ART counseling (8 weeks) individual 30-min counseling sessions once per week Receives: Behavioral: Streamlined Interpersonal Psychotherapy Groups (IPT-G) |
| SOC mental health counseling with SOC ART counseling. | No intervention | Receive treatment per Uganda national guidelines Standard Of Care (SOC) Mental Health Counseling (6-weeks) delivered by HIV clinic staff in 60-min sessions once per week and SOC ART counseling (8-weeks). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptomatology
PHQ-9, a standardized 9-item self-report instrument used to assess depression, is used. Participants rate the frequency of their symptoms over the past 2 weeks. Items are rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day), and scale scores range from 0 to 27. PHQ-9 scores of 5 to 9 represent minimal to mild depression and 10 to 20 represent moderate to severe depression. A score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression.
Measured: Baseline to 24 months post-intervention initiation
Secondary outcomes (1)
Viral Load
Viral Load (VL) Suppression (Biological assay) will be assessed through blood draws. In accordance with in-country cutoffs, VL will be dichotomized between undetectable (< 200 copies/ml) and detectable (≥ 200 copies/ml) levels.
Measured: Baseline to 12-months post intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies 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
- Masking
- None (open label)
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City University of New York, School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), New York University, Washington University Bursky School of Public Health
- Responsible party
- Principal investigator, Philip Kreniske, City University of New York, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637058
- Sponsor's protocol ID
- R01MH140406
- Other IDs
- R01MH140406
- Acronym
- STREAMS
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streamlined Treatment and Evidence-based Adolescent Counseling and Medication Support (STREAMS)
- ClinicalTrials.gov ID
- NCT07637058
- Acronym / sponsor ID
- STREAMS / R01MH140406
- Conditions
- Depression in Adolescence
- Keywords
- HIV, Uganda, mental health, depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- City University of New York, School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), New York University, Washington University Bursky School of Public Health
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 9 Jun 2026 (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.
Combination interventions to address mental health and adherence to HIV care in low- and middle-income countries (LMICs), are crucial to achieving the UNAIDS 95-95-95 targets as one in four adolescents living with HIV (ALWHIV) experience poor mental health and this contributes to suboptimal medication adherence and lack of viral suppression. Yet few evidence-based mental health and adherence interventions have been evaluated in sub-Saharan Africa (SSA), the region where the majority of the 1.7 million ALWHIV reside. STREAMS will determine if our streamlined combination intervention approach to mental health screening, provision of evidence-based interpersonal psychotherapy groups (IPT-G), and evidence-based family strengthening, and medication counseling is feasible and efficacious for ALWHIV in Uganda.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| streamlined IPT-G with streamlined Suubi+Adherence | Experimental | Behavioral: Streamlined Suubi+Adherence, Behavioral: Streamlined Interpersonal Psychotherapy Groups (IPT-G)Streamlined IPT-G (6 weeks) one 90-min StrongMinds group counseling session per week \& Suubi+Adherence (36 weeks) |
| streamlined IPT-G with SOC ART counseling | Experimental | Behavioral: Streamlined Interpersonal Psychotherapy Groups (IPT-G)Streamlined IPT-G (6 weeks) as described above \& Standard Of Care (SOC) ART counseling (8 weeks) individual 30-min counseling sessions once per week |
| SOC mental health counseling with SOC ART counseling. | No intervention | –Receive treatment per Uganda national guidelines Standard Of Care (SOC) Mental Health Counseling (6-weeks) delivered by HIV clinic staff in 60-min sessions once per week and SOC ART counseling (8-weeks). |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Living with HIV with confirmation by medical report and aware of their status
- Living within a family (defined broadly, not necessarily with biological parents); - - Between the ages of 15 to 19 years
- Prescribed ART
- Score a 10 or greater on the PHQ-9
Key exclusion criteria (1 listed)
- an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or caregiver.
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 |
|---|---|---|
| Streamlined Suubi+AdherenceParticipants in this intervention arm will receive: * Financial literacy training * Youth savings accounts The intervention aims to strengthen economic stability and support long-term treatment adherence and psychosocial well-being. | Behavioural | streamlined IPT-G with streamlined Suubi+Adherence |
| Streamlined Interpersonal Psychotherapy Groups (IPT-G)* Participants in the IPT-G intervention arms will attend: * Six weekly group counseling sessions, * Conducted in groups of approximately 6-10 adolescents, * Facilitated by trained StrongMinds counselors. The sessions will focus on: * Emotional wellbeing * Relationships * Coping with stress * Grief and loss * Social support * Problem-solving skills | Behavioural | streamlined IPT-G with SOC ART counseling, streamlined IPT-G with streamlined Suubi+Adherence |
Primary outcome
Depressive symptomatology
Time frame: Baseline to 24 months post-intervention initiation
PHQ-9, a standardized 9-item self-report instrument used to assess depression, is used. Participants rate the frequency of their symptoms over the past 2 weeks. Items are rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day), and scale scores range from 0 to 27. PHQ-9 scores of 5 to 9 represent minimal to mild depression and 10 to 20 represent moderate to severe depression. A score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression.
1 secondary outcome
Viral Load
Time frame: Baseline to 12-months post intervention initiation
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 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Depression in Adolescence
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Recruiting
Our Voices Matter: Intervention for Depression in Youth
Depressive Symptoms, Allostatic Load
Active, not recruiting
Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)
Depressive Symptoms
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.
Questions about this trial
What is this clinical trial studying?
A study testing Streamlined Suubi+Adherence and Streamlined Interpersonal Psychotherapy Groups (IPT-G) in people with Depression in Adolescence, run by City University of New York, School of Public Health.
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 4 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Philip Kreniske, PhD ((646) 364-9600, philip.kreniske@sph.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptomatology (time frame: Baseline to 24 months post-intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.