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

NCT07637058 | Not Yet Recruiting DMC

• 1 other identifier: R01MH140406
• Study Type: interventional
• Target: 588
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression in Adolescence

Keywords

HIV; Uganda; mental health; depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Viral Load

  Baseline to 12-months post intervention initiation

Other Outcomes (3)

• Anxiety

  Baseline to 24-months post intervention initiation

• Adherence measurement

  Baseline to 24 months post-intervention initiation

• General functioning

  Baseline to 24 months post-intervention initiation

Study Arms (3)

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)

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

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).

Interventions

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 IPT-G with streamlined Suubi+Adherence

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

streamlined IPT-G with SOC ART counseling; streamlined IPT-G with streamlined Suubi+Adherence

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• City University of New York, School of Public Health: lead
• National Institute of Mental Health (NIMH): collaborator
• New York University: collaborator
• Washington University Bursky School of Public Health: collaborator

MeSH Terms

Conditions

Psychological Well-Being; Depression

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms

Central Study Contacts

Philip Kreniske, PhD

CONTACT

(646) 364-9600; philip.kreniske@sph.cuny.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share