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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-19
SponsorCity University of New York, School of Public Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

588 Participants
are divided into 3 treatment groups
Group A: streamlined IPT-G with streamlined Suubi+AdherenceExperimental treatment 2 interventions
Group B: streamlined IPT-G with SOC ART counselingExperimental treatment 1 intervention
Group C: SOC mental health counseling with SOC ART counseling.No intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline to 24 months post-intervention initiation

Secondary outcomes

1

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.

Time frame
Baseline to 12-months post intervention initiation

Other outcomes

1

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.

Time frame
Baseline to 24-months post intervention initiation
2

Adherence measurement

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

Time frame
Baseline to 24 months post-intervention initiation
3

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

Time frame
Baseline to 24 months post-intervention initiation

Locations

This trial has no locations.

Sponsors and contacts

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City University of New York, School of Public Health

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

New York University

Collaborator

Washington University Bursky School of Public Health

Collaborator

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