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

NCT07637058 — Not applicable, Not yet recruiting, 588 participants, City University of New York, School of Public Health

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Registry	NCT07637058, acronym STREAMS
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	588 (Estimated)
Sponsor	City University of New York, School of Public Health (Other); collaborators: National Institute of Mental Health (NIMH), New York University, Washington University Bursky School of Public Health
Conditions	Depression in Adolescence
Interventions	Streamlined Suubi+Adherence, Streamlined Interpersonal Psychotherapy Groups (IPT-G) (Behavioral)
Dates	start 2026-12-01 (estimated), primary completion 2028-12-01 (estimated), completion 2030-08-01 (estimated), first posted 2026-06-09, last updated 2026-06-09

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
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).

Streamlined Suubi+Adherence (Behavioral): 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) (Behavioral): * 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

+Outcome measures

Primary outcomes

Depressive symptomatology [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.

Secondary outcomes

Viral Load [Baseline to 12-months post intervention initiation]: 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.

Other outcomes

Anxiety [Baseline to 24-months post intervention initiation]: 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.
Adherence measurement [Baseline to 24 months post-intervention initiation]: The three-item Self-reported ART adherence measure used in prior Suubi studies
General functioning [Baseline to 24 months post-intervention initiation]: 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

+Eligibility

Sex: All, ages: 15 Years to 19 Years

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.

+Funding

NIH grants: R01MH140406