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NCT Number: NCT07637058

Streamlined Treatment and Evidence-based Adolescent Counseling and Medication Support (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.

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Key information

Conditions

Depression in Adolescence Behavior Behavioral Symptoms Depression Personal Satisfaction Psychological Well-Being

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Viral Load

    Time frame: 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

  1. Anxiety

    Time frame: 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.

  2. Adherence measurement

    Time frame: Baseline to 24 months post-intervention initiation

    The three-item Self-reported ART adherence measure used in prior Suubi studies

  3. General functioning

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Philip Kreniske, PhD

CONTACT

[email protected]

(646) 364-9600

Sponsors and collaborators

Lead 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

Registry information

Acronym: STREAMS

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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