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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07637058
Acronym
STREAMS
Enrollment
588
Registered
2026-06-09
Start date
2026-12-01
Completion date
2030-08-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression in Adolescence

Keywords

HIV, Uganda, mental health, depression

Brief 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.

Interventions

BEHAVIORALStreamlined 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.

BEHAVIORALStreamlined 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

Sponsors

City University of New York, School of Public Health
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
New York University
CollaboratorOTHER
Washington University Bursky School of Public Health
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Participants and care providers will know which intervention is being given but will not know about the interventions given in the other 2 arms of the study.

Eligibility

Sex/Gender
ALL
Age
15 Years to 19 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Depressive symptomatologyBaseline to 24 months post-intervention initiationPHQ-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

MeasureTime frameDescription
Viral LoadBaseline to 12-months post intervention initiationViral 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.

Contacts

CONTACTPhilip Kreniske, PhD
philip.kreniske@sph.cuny.edu(646) 364-9600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026