Streamlined Treatment and Evidence-based Adolescent Counseling and Medication Support (STREAMS) (STREAMS)

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 Overview

• Status: Not yet recruiting
• Conditions: Depression in Adolescence
• Intervention / Treatment: Behavioral: Streamlined Suubi+Adherence; Behavioral: Streamlined Interpersonal Psychotherapy Groups (IPT-G)

• Study Type: Interventional
• Enrollment (Estimated): 588
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip Kreniske, PhD; Phone Number: (646) 364-9600; Email: philip.kreniske@sph.cuny.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or caregiver.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: streamlined IPT-G with streamlined Suubi+Adherence; Streamlined IPT-G (6 weeks) one 90-min StrongMinds group counseling session per week & Suubi+Adherence (36 weeks)	Behavioral: Streamlined Suubi+Adherence; 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.; Behavioral: 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
Experimental: streamlined IPT-G with SOC ART counseling; Streamlined IPT-G (6 weeks) as described above & Standard Of Care (SOC) ART counseling (8 weeks) individual 30-min counseling sessions once per week	Behavioral: 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
No Intervention: SOC mental health counseling with SOC ART counseling.; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 24 months post-intervention initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 12-months post intervention initiation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	The GAD-7 is a standardized instrument that asks participants to rate their symptoms over the past two weeks on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Overall scores for the GAD-7 range from 0 to 21. At a cut-point of 10 (indicative of clinically significant symptoms), the sensitivity and specificity of the scale equals 89% and 82% respectively. The GAD-7 has a Cronbach's of .92, indicating good internal consistency with an intra-class correlation of .83, indicating good procedural validity.	Baseline to 24-months post intervention initiation
Adherence measurement	The three-item Self-reported ART adherence measure used in prior Suubi studies	Baseline to 24 months post-intervention initiation
General functioning	Children's Global Assessment Scale (CGAS)136, an adaptation of the Global Assessment Scale for adults, young people scored between 1 to 100, with 10 categories. Participants with CGAS score of 1-10 needs constant supervision, with scores of 91-100 means superior functioning. CGAS can be a useful measure of overall severity of disturbance. It was found to have moderate to good reliability between raters and across time, as measured by intraclass correlation	Baseline to 24 months post-intervention initiation

Collaborators and Investigators

• Sponsor: City University of New York, School of Public Health
• Collaborators: National Institute of Mental Health (NIMH); New York University; Washington University Bursky School of Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: HIV; depression; mental health; Uganda
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Personal Satisfaction; Depression; Psychological Well-Being
• Other Study ID Numbers: R01MH140406 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No